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🗂 Field Registry field_registry_3_4.yaml 238 fields

Study Design And Definition

43 fields

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Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
study_design_and_definition.id	ALWAYS	—	Title Page Header/Footer Synopsis	Protocol No. Protocol Number Protocol ID Study ID Study Number +2
Definition: Unique protocol identifier or number. Format: `Text string` Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND Protocol Number: BRX-RA-2024-001 NOT_FOUND The protocol does not explicitly state the id.
study_design_and_definition.name	ALWAYS	ICH M11 §1.1; SPIRIT 2013 Item 1; CDISC SDTM TS TSPARMCD=TITLE	Title Page Synopsis Protocol Cover	Title of Study Study Title Protocol Title Title: A Phase +3
Definition: The official title of the clinical study as it appears on the protocol cover page. Format: `Free text string` Capture Guidance: Use the full formal title from the cover page or header. Do not abbreviate. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Drug X in Patients... FOUND Study to Evaluate Safety and Efficacy of Compound ABC NOT_FOUND The protocol does not explicitly state the name.
study_design_and_definition.protocolVersion	ALWAYS	ICH M11 §1; SPIRIT 2013 Item 3	Title Page Synopsis Title Page (Version field) Header/Footer Cover Page	Version Revision Protocol Version Document Version Amendment +8
Definition: The version number or identifier of the current protocol document. If the protocol uses numeric version numbers (e.g., "1.0", "2.1"), extract the number directly. If the protocol uses only amendment numbers without explicit version numbering (e.g., "Amendment 2"), extract the amendment label as-is. Do NOT infer a numeric version from the amendment sequence unless explicitly stated in the document. Format: `String — numeric (e.g., "3.0") or amendment label (e.g., "Amendment 2")` Capture Guidance: Take the latest version identifier from the cover page or amendment history. If the protocol states both a version number and an amendment number, extract the version number. If only an amendment number is stated (common in industry protocols), extract the amendment label (e.g., "Amendment 2"). Do not infer sequential version numbers (e.g., "3") from amendment count (e.g., Original + Amendment 1 + Amendment 2 ≠ version "3" unless the protocol explicitly says so). Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND Protocol Version 3.0, dated 15 January 2025 FOUND Amendment 2 to Protocol v1.1 FOUND Protocol Amendment 2, 16 Aug 2022 (no version number stated)
study_design_and_definition.protocolDate	ALWAYS	ICH M11 §1; SPIRIT 2013 Item 3	Title Page Synopsis Adjacent to Version on Title Page Header/Footer (date stamp) Cover Page	Effective date Date Protocol Date Approved Version Date +10
Definition: The date the protocol version was finalized or approved. Format: `ISO date string (YYYY-MM-DD)` Capture Guidance: Extract the date associated with the current protocol version from cover page. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND Protocol Date: 15 January 2025 FOUND Approved Jan 2025 NOT_FOUND The protocol does not explicitly state the protocolDate.
study_design_and_definition.sponsor	ALWAYS	ICH M11 §1; SPIRIT 2013 Item 5a; ICH E6(R2) §1.53	Title Page (Sponsor field) [HIGH PRIORITY] Cover Page Administrative Information Protocol Number prefix for NIH intramural [MEDIUM -- requires institute code lookup] Synopsis	Sponsor Sponsored by Funding Sponsor name Sponsor: +8
Definition: The organisation that initiates, manages, and finances the study. Format: `Free text string` Capture Guidance: Use the formal sponsor name from the cover page. For NIH intramural protocols: the sponsoring institute is encoded in the protocol number prefix (e.g., CH = NICHD, DK = NIDDK, HG = NHGRI, AI = NIAID, CC = Clinical Center). The PI's home institute may differ from the protocol-owning institute. Use the protocol number prefix to determine the sponsor. For academic investigator-initiated studies: the sponsor is the institution holding the IND/IDE or listed as responsible party. If the IND is held by an external entity (e.g., pharma partner under CRADA), note both the study sponsor and IND sponsor in evidence but extract the study sponsor here. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND This study is sponsored by Acme Pharmaceuticals, Inc. FOUND Project Number: 11-CH-0208. PI: Dr. Smith, NIDDK. IND 113698 sponsored by HRA-Pharma. NOT_FOUND The protocol does not explicitly state the sponsor.
study_design_and_definition.regulatoryIdentifier	COND_PROTECTED	ICH M11 §1; SPIRIT 2013 Item 2a	Title Page Synopsis Title Page (IND/IDE/CTA field) Administrative Information Regulatory section	Protocol number IND Sponsor protocol number EudraCT IND No. +9
Definition: Official regulatory tracking numbers associated with the study (e.g. IND, EudraCT). Format: `Free text or structured identifier string` Capture Guidance: Collect the main protocol identifier. EudraCT format: YYYY-NNNNNN-NN. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the regulatoryIdentifier: Example regulatoryIdentifier. FOUND An abbreviated or edge-case statement still identifies the regulatoryIdentifier:... NOT_FOUND This protocol section indicates the regulatoryIdentifier does not apply for this study design.
study_design_and_definition.trialRegistryIdentifier	COND_PROTECTED	ICH M11 §1; SPIRIT 2013 Item 2a; WHO ICTRP	Title Page Synopsis Title Page (NCT/EudraCT field) Background section Administrative Information	NCT ClinicalTrials.gov Registry CTRI JRCT +11
Definition: Public trial registry identifier (e.g. NCT number from ClinicalTrials.gov). Format: `String (e.g. 'NCT01234567')` Capture Guidance: NCT numbers start with 'NCT' followed by 8 digits. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the trialRegistryIdentifier: Example trialRegistryIdentifier. FOUND An abbreviated or edge-case statement still identifies the trialRegistryIdentifier:... NOT_FOUND This protocol section indicates the trialRegistryIdentifier does not apply for this...
study_design_and_definition.usdmVersion	SYSTEM	CDISC USDM	Synopsis Study Design	—
Definition: Version of the CDISC Unified Study Definitions Model (USDM) used for the study definition. Format: `String (e.g. '3.0')` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the usdmVersion.
study_design_and_definition.rationale	CONDITIONAL	ICH M11 §3; SPIRIT 2013 Item 6a; ICH E8(R1) §3	Synopsis Study Design Background Background and Rationale section Scientific Rationale section Study Rationale section	Scientific rationale Rationale Unmet need Background Justification +12
Definition: Scientific justification for conducting the study, including unmet need and design rationale. Format: `Free text (paragraph)` Capture Guidance: Summarise the key rationale, focusing on why this study is needed. Extraction Boundary: Extract the scientific or clinical rationale for conducting the study. Do not substitute the study objective or endpoint statement for the rationale. Examples: FOUND The protocol explicitly states the rationale: Example rationale. FOUND An abbreviated or edge-case statement still identifies the rationale: Abbrev rationale. NOT_FOUND This protocol section indicates the rationale does not apply for this study design.
study_design_and_definition.studyType	ALWAYS	ICH M11 §4; CDISC SDTM TS TSPARMCD=STYPE	Title Page Study Design Synopsis DO NOT SEARCH — This field is DERIVED	Study type Interventional Expanded access Observational
Definition: High-level classification of the study (e.g. interventional, observational, expanded access). Format: `Enum string` Capture Guidance: Classify as INTERVENTIONAL if the protocol administers any treatment, drug, device, or procedure to participants. OBSERVATIONAL if no intervention is assigned. EXPANDED_ACCESS for compassionate use. Most protocols with randomization, study drug, or placebo are INTERVENTIONAL. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND Prospective, randomized, placebo-controlled, cross-over study FOUND INFERRED: Protocol describes drug administration, IND, and randomization but does not... NOT_FOUND The protocol does not explicitly state the studyType. Allowed Values: INTERVENTIONAL OBSERVATIONAL EXPANDED_ACCESS Value Aliases: `INTERVENTIONAL`: Interventional, interventional, Clinical trial, Interventional study, Treatment study `OBSERVATIONAL`: Observational, observational, Non-interventional, non-interventional, NIS, Registry, Surveillance `EXPANDED_ACCESS`: Expanded access, expanded access, Compassionate use, compassionate use, Named patient, Emergency use, EXPANDED ACCESS
study_design_and_definition.trialType	CONDITIONAL	ICH M11 §4; SPIRIT 2013 Item 7; CDISC SDTM TS TSPARMCD=TTYPE	Study Design Synopsis Objectives section (primary objective) Synopsis (study purpose) Title Page	Efficacy Pharmacokinetic Safety Dose-finding Trial type +20
Definition: Classification of the trial by its primary scientific purpose. Format: `Enum string` Capture Guidance: Classify by the primary scientific purpose of the study — what the trial MEASURES, not what the trial DOES. This field captures the measurement purpose (EFFICACY, SAFETY, PHARMACOKINETICS, etc.), NOT the intervention category (treatment, prevention, diagnostic). A treatment trial that measures clinical outcomes is EFFICACY. A prevention trial that measures vaccine efficacy is also EFFICACY. Do not return TREATMENT, PREVENTION, or DIAGNOSTIC — those describe what the intervention does, not what the trial measures. If the primary endpoint is a biomarker or pharmacodynamic parameter (e.g., insulin sensitivity index, tumor shrinkage on imaging) rather than a clinical outcome (e.g., overall survival, HbA1c reduction over 6+ months), classify as PHARMACODYNAMICS, not EFFICACY. Pilot studies measuring drug effect on physiological parameters are typically PHARMACODYNAMICS. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND Primary outcome: change in insulin sensitivity index based on FSIVGTT. FOUND Primary endpoint: overall survival at 24 months. NOT_FOUND This protocol section indicates the trialType does not apply for this study design. Allowed Values: SAFETY EFFICACY PHARMACOKINETICS PHARMACODYNAMICS BIOEQUIVALENCE DOSE_FINDING EXPANDED_ACCESS OTHER Value Aliases: `SAFETY`: Safety, safety, Safety study, Tolerability `EFFICACY`: Efficacy, efficacy, Efficacy study, Effectiveness `PHARMACOKINETICS`: Pharmacokinetics, pharmacokinetics, PK, pk, PK study, Pharmacokinetic study, Bioavailability `PHARMACODYNAMICS`: Pharmacodynamics, pharmacodynamics, PD, pd, PD study, Pharmacodynamic study, Proof of concept, Proof-of-concept, POC, Biomarker study, Pilot efficacy with biomarker endpoint `BIOEQUIVALENCE`: Bioequivalence, bioequivalence, BE, BE study, Bioequivalence study `DOSE_FINDING`: Dose-finding, dose-finding, Dose finding, dose finding, Dose ranging, dose-ranging, Dose escalation
study_design_and_definition.phaseCode	COND_PROTECTED	ICH M11 §4.1; SPIRIT 2013 Item 7; CDISC SDTM TS TSPARMCD=TPHASE;...	Title Page Study Design Synopsis Enforced order: Title Page Synopsis/Protocol Summary Study Design Overview	Phase 2 Phase 1 First-in-human Phase 4 Phase 3 +16
Definition: The clinical development phase of the study. Format: `Enum string` Capture Guidance: Use combined phases (PHASE1/PHASE2) when both are stated. EARLY_PHASE1 for first-in-human. If the protocol does not state any phase and is described solely as a "pilot study" or "proof-of-concept" without a phase designation, return null. Do not infer a phase from study size or design alone. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the phaseCode: EARLY_PHASE1. FOUND An abbreviated or edge-case statement still identifies the phaseCode: PHASE1. NOT_FOUND The protocol does not explicitly state the phaseCode. Allowed Values: EARLY_PHASE1 PHASE1 PHASE1/PHASE2 PHASE2 PHASE2/PHASE3 PHASE3 PHASE4 NA Value Aliases: `EARLY_PHASE1`: Early Phase 1, Early Phase I, Phase 0, Phase 0/1, Pre-clinical/Phase 1, First-in-human, FIH, early phase 1, EARLY_PHASE_1, EarlyPhase1 `PHASE1`: Phase 1, Phase I, PHASE I, P1, Ph1, Ph 1, Phase1, PHASE_1, phase 1, phase i, Phase-1, Phase Ⅰ, Phase 1a, Phase 1b, Phase Ia, Phase Ib `PHASE1/PHASE2`: Phase 1/2, Phase I/II, Phase 1/Phase 2, Phase I/Phase II, PHASE1_PHASE2, Phase 1b/2a, Phase 1b/2, Phase 1/2a, Phase Ib/IIa, Phase Ib/II, P1/P2, Ph1/2, phase 1/2, Phase 1 / Phase 2, Phase I / II, Phase Ⅰ/Ⅱ, PHASE1-PHASE2, PHASE1PHASE2 `PHASE2`: Phase 2, Phase II, PHASE II, P2, Ph2, Ph 2, Phase2, PHASE_2, phase 2, phase ii, Phase-2, Phase Ⅱ, Phase 2a, Phase 2b, Phase IIa, Phase IIb `PHASE2/PHASE3`: Phase 2/3, Phase II/III, Phase 2/Phase 3, Phase II/Phase III, PHASE2_PHASE3, Phase 2b/3, Phase IIb/III, P2/P3, Ph2/3, phase 2/3, Phase 2 / Phase 3, Phase II / III, Phase Ⅱ/Ⅲ, PHASE2-PHASE3, PHASE2PHASE3 `PHASE3`: Phase 3, Phase III, PHASE III, P3, Ph3, Ph 3, Phase3, PHASE_3, phase 3, phase iii, Phase-3, Phase Ⅲ, Phase 3a, Phase 3b, Phase IIIa, Phase IIIb, Pivotal `PHASE4`: Phase 4, Phase IV, PHASE IV, P4, Ph4, Ph 4, Phase4, PHASE_4, phase 4, phase iv, Phase-4, Phase Ⅳ, Post-marketing, Post-approval, Postmarketing `NA`: N/A, Not Applicable, not applicable, NA, n/a, None, NOT_APPLICABLE
study_design_and_definition.studyPhase	ALWAYS	ICH M11 §4.1; ICH E8(R1) §4	Synopsis Study Design	Phase Development phase
Definition: Human-readable description of the study phase (may include narrative elaboration). Format: `Free text` Capture Guidance: Narrative version of phaseCode. E.g. 'Phase 2b dose-finding study'. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the studyPhase: Example studyPhase. FOUND An abbreviated or edge-case statement still identifies the studyPhase: Abbrev studyPhase. NOT_FOUND The protocol does not explicitly state the studyPhase.
study_design_and_definition.interventionModel	CONDITIONAL	ICH M11 §4.2; SPIRIT 2013 Item 7; CDISC SDTM TS TSPARMCD=INTMODEL	Title Page Study Design Synopsis Synopsis (study design descriptor) Study Design section Methods	Crossover Sequential Factorial Parallel Single group +19
Definition: The general design framework describing how participants are assigned to interventions. Format: `Enum string` Capture Guidance: PARALLEL = separate groups concurrently. CROSSOVER = all groups receive all treatments in sequence with washout. SINGLE_GROUP = one arm, no comparator. SEQUENTIAL = dose escalation or adaptive. FACTORIAL = 2+ factors combined. For crossover: the presence of washout between treatment periods, "each subject serving as own control," or "AB/BA" design confirms CROSSOVER. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the interventionModel: PARALLEL. FOUND An abbreviated or edge-case statement still identifies the interventionModel: CROSSOVER. NOT_FOUND This protocol section indicates the interventionModel does not apply for this study design. Allowed Values: PARALLEL CROSSOVER SEQUENTIAL SINGLE_GROUP FACTORIAL Value Aliases: `PARALLEL`: Parallel, Parallel-group, Parallel group, Parallel arm, parallel, parallel-group, PARALLEL_GROUP, Parallel assignment, Parallel Assignment, Parallel Group, Parallel Design, Parallel design `CROSSOVER`: Crossover, Cross-over, Cross over, crossover, cross-over, CROSS_OVER, AB/BA, Crossover Assignment, Crossover Design, Crossover design, 2x2 crossover, 2-period crossover, N-of-1 `SEQUENTIAL`: Sequential, sequential, Dose escalation, dose-escalation, Dose-finding, Sequential Assignment, Sequential assignment, Sequential Design, 3+3 `SINGLE_GROUP`: Single group, Single-group, Single arm, Single-arm, single group, single-group, single arm, single-arm, SINGLE_ARM, Single Group Assignment, Single Arm, One Arm, One-arm, one arm `FACTORIAL`: Factorial, factorial, 2x2 factorial, 2×2 factorial, Factorial Assignment, Factorial Design, Factorial design, Multi-factorial
study_design_and_definition.interventionType	CONDITIONAL	ICH M11 §4.3; SPIRIT 2013 Item 11a; CDISC SDTM TS TSPARMCD=INTTYPE	Study Design Interventions Synopsis Interventions section Study Arms Investigational Product section	Drug Dietary supplement Behavioral Biological Device +16
Definition: The category of intervention being studied. Format: `Enum string` Capture Guidance: Identify the primary intervention category from the protocol. Classify by the SCIENTIFIC NATURE of the substance, not by the regulatory filing pathway (NDA vs BLA). Peptide analogues with high homology to endogenous human proteins (e.g., GLP-1 receptor agonists like semaglutide, liraglutide; insulin analogues; growth hormone analogues) should be classified as BIOLOGICAL, even if they are regulated under a drug application (NDA) rather than a biologic license application (BLA). Small molecules (e.g., metformin, atorvastatin) = DRUG. Monoclonal antibodies, vaccines, mRNA = BIOLOGICAL. Implants, devices = DEVICE. When uncertain, prefer BIOLOGICAL for any substance described as an 'analogue', 'peptide', 'protein', or having 'homology to human' protein sequences. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the interventionType: DRUG. FOUND Semaglutide is a next-generation GLP-1 receptor analogue with a high degree of... NOT_FOUND This protocol section indicates the interventionType does not apply for this study design. Allowed Values: DRUG BIOLOGICAL DEVICE BEHAVIORAL DIETARY_SUPPLEMENT PROCEDURE RADIATION GENETIC COMBINATION OTHER Value Aliases: `DRUG`: Drug, drug, Small molecule, Chemical entity, Pharmaceutical, pharmaceutical, Compound `BIOLOGICAL`: Biological, Biologic, biological, biologic, Antibody, Monoclonal antibody, mAb, Biosimilar, Protein, Fusion protein, Vaccine, vaccine, mRNA, Gene therapy, Cell therapy, Peptide analogue, Peptide, GLP-1 receptor agonist, Insulin analogue, Growth hormone analogue, Analogue `DEVICE`: Device, device, Medical device, medical device, Implant, Diagnostic device `BEHAVIORAL`: Behavioral, Behavioural, behavioral, behavioural, Psychological, Cognitive behavioral therapy, CBT `DIETARY_SUPPLEMENT`: Dietary supplement, dietary supplement, Supplement, Nutraceutical, Nutritional supplement `PROCEDURE`: Procedure, procedure, Surgical, Surgery, Surgical procedure, Intervention procedure `RADIATION`: Radiation, radiation, Radiotherapy, RT, Radiation therapy, Irradiation `GENETIC`: Genetic, genetic, Gene therapy, gene therapy, Antisense, siRNA, ASO, CRISPR `COMBINATION`: Combination, combination, Combination product, Drug-device combination, Multi-modal
study_design_and_definition.allocation	CONDITIONAL	ICH M11 §4.2; SPIRIT 2013 Item 16a; CDISC SDTM TS TSPARMCD=RANDOM	Study Design Synopsis Title Page	Randomized Randomised Allocation Non-randomized randomized +6
Definition: Method by which participants are assigned to study arms. Format: `Enum string` Capture Guidance: RANDOMIZED if any random allocation method is described, including block randomization, stratified randomization, or IWRS. NON_RANDOMIZED for physician-choice, consecutive enrollment, or single-arm designs with no comparator. Observational studies (cohort, case-control, cross-sectional, registry) are inherently NON_RANDOMIZED — do not return RANDOMIZED for an observational study even if the word 'random' appears in a sampling context (random sampling is not random allocation). If the study type is observational, default to NON_RANDOMIZED. Extraction Boundary: Extract only whether arm assignment is randomized or non-randomized. Do not extract the allocation ratio, the randomization method, or stratification factors here. Examples: FOUND Patients will be randomized in a 1:1 ratio to Drug A or placebo. FOUND Assignment will follow the treating physician's clinical judgment. NOT_FOUND This is a single-arm, open-label study in which all participants receive the... Allowed Values: RANDOMIZED NON_RANDOMIZED Value Aliases: `RANDOMIZED`: Randomized, Randomised, randomized, randomised, Random allocation, Random Allocation, Randomly assigned, randomly allocated, RCT, random, Random, RANDOM `NON_RANDOMIZED`: Non-randomized, Non-randomised, Non Randomized, Nonrandomized, Nonrandomised, non-randomized, non-randomised, Not randomized, Not Randomized, Not randomised, Single-arm, single arm, Open enrollment, Physician choice, NON-RANDOMIZED, NONRANDOMIZED
study_design_and_definition.allocationRatio	CONDITIONAL	ICH M11 §4.5; SPIRIT 2013 Item 16a	Study Design Synopsis Randomization section (ratio statement) Study Arms section Sample Size section	Randomization ratio 1:1 Ratio Allocation ratio 2:1 +13
Definition: The ratio describing how participants are allocated across arms. Format: `Colon-separated ratio string (e.g., '1:1', '2:1:1')` Capture Guidance: Extract the explicit colon-separated ratio (e.g., 1:1, 2:1). For crossover designs, the ratio refers to assignment to treatment sequences (e.g., AB vs BA), not to arms directly. If the ratio is not explicitly stated (e.g., only "randomized in blocks of 6" without stating the ratio), return null. Do not infer 1:1 from block size alone. REDACTION RULE: If the allocation ratio text is redacted (CCI, PPD, or similar) but sample sizes per arm are stated, the ratio MAY be computed from sample sizes. In this case, set confidence to "medium" and prefix reasoning_summary with "DERIVED: Ratio computed from stated sample sizes. Explicit ratio text was redacted." Simplify to lowest integer terms (e.g., 50:100:100:100:100:100 → 1:2:2:2:2:2). Extraction Boundary: Extract only the colon-separated assignment ratio such as 1:1 or 2:1:1. Remove surrounding randomization wording and do not capture the allocation classification or randomization method. Examples: FOUND Subjects will be randomized 2:1 to active treatment or placebo. FOUND Participants are assigned in a 1:1:1 ratio across three treatment groups. FOUND Participants are randomized [CCI REDACTED] to Group 1 (n=50), Group 2 (n=100), Group 3 (n=100).
study_design_and_definition.randomizationMethod	CONDITIONAL	ICH M11 §4.5; SPIRIT 2013 Item 16a; ICH E9 §2.3.1	Study Design Synopsis Randomization section Study Design section Statistical Methods	Permuted block IWRS Block randomization Central randomization IVRS +18
Definition: The specific technique used to generate the random allocation sequence. Format: `Free text` Capture Guidance: Describe the method (e.g., "Block randomization in blocks of 6", "Stratified block randomization via IWRS"). Include the block size if stated. Include the entity performing randomization if stated (e.g., "Pharmaceutical Development Service", "central IWRS"). Extraction Boundary: Extract only the implementation method of randomization such as block, stratified, centralized, or IWRS. Do not restate whether the study is randomized or the allocation ratio. Examples: FOUND The protocol explicitly states the randomizationMethod: Example randomizationMethod. FOUND An abbreviated or edge-case statement still identifies the randomizationMethod: Abbrev... NOT_FOUND This protocol section indicates the randomizationMethod does not apply for this study design. Value Aliases: `BLOCK`: Block Randomization, Blocked Randomization, Permuted Block, Permuted block, permuted block randomization, Block randomization, blocked randomization `STRATIFIED`: Stratified Randomization, Stratified Block, Stratified randomization, stratified block, Stratified block randomization `SIMPLE`: Simple Randomization, Simple randomization, Complete randomization, Complete Randomization `ADAPTIVE`: Adaptive Randomization, Response-Adaptive, Response-adaptive randomization, Minimization, minimization, Covariate-adaptive, covariate-adaptive randomization, Biased coin, Dynamic randomization
study_design_and_definition.stratificationFactors	CONDITIONAL	ICH M11 §4.5; SPIRIT 2013 Item 16a; ICH E9 §2.3.2	Statistical Considerations Study Design Synopsis Randomization section Statistical Methods IWRS/IRT description	Stratified by Strata Stratification factors Stratification stratified by +8
Definition: Factors used to stratify randomization to ensure balance across prognostic variables. Format: `List of strings` Capture Guidance: List each factor (e.g. 'disease severity', 'geographic region'). Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the stratificationFactors: ['Example item 1', 'Example item 2']. FOUND An abbreviated or edge-case statement still identifies the stratificationFactors:... NOT_FOUND This protocol section indicates the stratificationFactors does not apply for this study design.
study_design_and_definition.blindingSchema	CONDITIONAL	ICH M11 §4.2; SPIRIT 2013 Item 11b; CDISC SDTM TS TSPARMCD=BLIND	Study Design header [HIGH -- e.g., "double-blind" in design descriptor] Synopsis Pharmaceutical Safety / Randomization [HIGH -- matching placebo + blinding procedures] Study Arms section	Double-blind Masking Blinding Open-label Single-blind +18
Definition: The degree of masking/blinding applied in the study. Format: `Enum string` Capture Guidance: Map to the enum using the declared masking label. Observer-blind maps to SINGLE. Double-blind maps to DOUBLE. Open-label maps to NONE. IMPORTANT: "Observer-blind" protocols vary in actual masking scope. Some are functionally double-blind (participants + observers blinded) but labeled "observer-blind" because matching is imperfect (e.g., different injection volumes or appearances). When "observer-blind" is stated but the protocol ALSO describes participant blinding (e.g., opaque syringe sleeves, identical-appearing IPs), extract the declared label (maps to SINGLE) but note the discrepancy in reasoning_summary: "Protocol declared observer-blind (SINGLE) but describes blinding of [list all blinded parties]. Functionally closer to DOUBLE. See maskingRoles for detail." Capture the per-role detail in the new study_design_and_definition.maskingRoles field. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND This is a double-blind, placebo-controlled study. FOUND A look-alike inert placebo will be formulated. The investigators will not be informed... FOUND This is an open-label study. Allowed Values: NONE SINGLE DOUBLE TRIPLE QUADRUPLE Value Aliases: `NONE`: Open-label, Open label, Unblinded, No blinding, No masking, open-label, open label, OPEN_LABEL, OPEN-LABEL, Open Label, Not blinded, Unmasked, non-blinded, Non-blinded, None (Open Label), No Masking `SINGLE`: Single-blind, Single blind, Single-masked, Single masked, single-blind, SINGLE_BLIND, Single Blind, Participant-blind, Investigator-blind, Assessor-blind, Rater-blind, Observer-blind, Observer blind, OBSERVER_BLIND, Observer Blind, observer-blind `DOUBLE`: Double-blind, Double blind, Double-masked, Double masked, double-blind, DOUBLE_BLIND, Double Blind, Dual masked, Participant and investigator blinded, Subject and investigator blind, Participant, Investigator `TRIPLE`: Triple-blind, Triple blind, Triple-masked, Triple masked, triple-blind, TRIPLE_BLIND, Triple Blind `QUADRUPLE`: Quadruple-blind, Quadruple blind, Quadruple-masked, quadruple-blind, QUADRUPLE_BLIND, Quadruple Blind
study_design_and_definition.studyTypeMasking	CONDITIONAL	ICH M11 §4.4; SPIRIT 2013 Item 11b	Study Design Synopsis Title Page (in study descriptor) Synopsis (Design section) Study Design section	Unblinding Masking Blinding procedures Who is blinded open-label +26
Definition: Narrative description of the masking/blinding approach including which parties are masked. Format: `Free text` Capture Guidance: Describe which parties are blinded and how blinding is maintained. Explicitly list ALL blinded parties named in the protocol, including those with advisory blinding (e.g., 'should preferably be unaware'). Distinguish between mandatory and advisory blinding in the narrative. For double-blind studies, explicitly name the blinding mechanism (e.g., visually identical products, IWRS-based unblinding). Include any outcome assessors, treadmill technicians, or other evaluation personnel described as blinded. This field complements blindingSchema (enum) and maskingRoles (list) by providing the full narrative description. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the studyTypeMasking: Example studyTypeMasking. FOUND An abbreviated or edge-case statement still identifies the studyTypeMasking: Abbrev... NOT_FOUND The protocol does not explicitly state the studyTypeMasking.
study_design_and_definition.controlType	CONDITIONAL	ICH M11 §4.2; ICH E10; CDISC SDTM TS TSPARMCD=CONTROL	Study Design Arms Synopsis Study Arms (control arm description) Comparator section Randomization	Sham Active control Dose-comparison Standard of care Placebo +12
Definition: Type of control used for comparison in the study. Format: `Enum string` Capture Guidance: PLACEBO=inert comparator. ACTIVE=marketed drug (different molecule from investigational product). DOSE_COMPARISON=all arms receive the SAME investigational product at different dose levels, with no separate placebo or different active agent; the comparator dose may be an approved dose of the same molecule. UNCONTROLLED=no comparator arm. IMPORTANT: DOSE_COMPARISON vs ACTIVE boundary: use DOSE_COMPARISON when the comparator is a different dose of the SAME molecule as the investigational product. Use ACTIVE when the comparator is a DIFFERENT marketed drug/molecule. If the study compares both different doses AND different molecules, use ACTIVE and note the dose-comparison element in reasoning_summary. IMPORTANT: When a study uses active comparators (e.g., licensed vaccines) AND also uses placebo as a matching injection for blinding purposes (e.g., one arm receives active vaccine + matching placebo saline injection in the other arm to maintain two-injection blinding), classify as ACTIVE — not PLACEBO. The control type should reflect the scientific comparator, not the blinding mechanism. A PLACEBO classification requires at least one arm where participants receive ONLY placebo with no active treatment in any injection. For vaccine studies with matching saline injections alongside active comparators, the control type is ACTIVE. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the controlType: PLACEBO. FOUND An abbreviated or edge-case statement still identifies the controlType: ACTIVE. FOUND Arm 1: Vaccine A + placebo (saline in other arm). Arm 2: Vaccine B + placebo. Arm 3:... Allowed Values: PLACEBO ACTIVE DOSE_COMPARISON NO_TREATMENT STANDARD_OF_CARE SHAM UNCONTROLLED Value Aliases: `PLACEBO`: Placebo, placebo, Placebo-controlled, placebo-controlled, Placebo controlled, Placebo control, Matching placebo `ACTIVE`: Active control, Active comparator, Active-controlled, active control, active comparator, ACTIVE_COMPARATOR, Active controlled, Active-comparator `DOSE_COMPARISON`: Dose comparison, Dose-comparison, dose comparison, Dose-ranging, Dose finding, Dose escalation control `NO_TREATMENT`: No treatment, No intervention, no treatment, Untreated, Observation only, NO_INTERVENTION `STANDARD_OF_CARE`: Standard of care, SOC, Best supportive care, BSC, Usual care, standard of care, Standard-of-care, Standard therapy, Best available therapy, BAT `SHAM`: Sham, sham, Sham-controlled, Sham control, Sham procedure, Sham device `UNCONTROLLED`: Uncontrolled, No control, uncontrolled, No comparator, Single-arm (no control)
study_design_and_definition.numberOfArms	ALWAYS	ICH M11 §4.2; SPIRIT 2013 Item 8	Study Design Arms Synopsis Study Arms section Synopsis (design overview) Study Design section	Number of arms Treatment groups Arms arms arm +18
Definition: The total number of treatment arms in the study. Return the count as an integer. The names of arms are captured in arms.armName. Format: `Integer` Capture Guidance: Count distinct treatment arms including placebo/control. Single-arm = 1. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the numberOfArms: Example numberOfArms. FOUND An abbreviated or edge-case statement still identifies the numberOfArms: Abbrev numberOfArms. NOT_FOUND The protocol does not explicitly state the numberOfArms.
study_design_and_definition.studyArms	ALWAYS	ICH M11 §4.2; SPIRIT 2013 Item 8	Study Design Arms Synopsis Study Arms section Treatment Groups section Randomization	Arm description Treatment arms Arms Study arms Arm +18
Definition: Summary listing of the study arms with brief descriptions. Format: `Free text or structured list` Capture Guidance: List each arm with its name and brief description. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the studyArms: ['Example item 1', 'Example item 2']. FOUND An abbreviated or edge-case statement still identifies the studyArms: ['Abbrev item']. NOT_FOUND The protocol does not explicitly state the studyArms.
study_design_and_definition.observationalModel	CONDITIONAL	ICH M11 §4; STROBE; CDISC SDTM TS TSPARMCD=OBSMODEL	Study Design Synopsis Synopsis (study design type) Study Design section Title Page	Case-control Cross-sectional Cohort Observational model cohort +11
Definition: For observational studies, the specific observational design used. Format: `Enum string` Capture Guidance: Only relevant when studyType=OBSERVATIONAL. Leave empty for interventional studies. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the observationalModel: COHORT. FOUND An abbreviated or edge-case statement still identifies the observationalModel: CASE_CONTROL. NOT_FOUND This protocol section indicates the observationalModel does not apply for this study design. Allowed Values: COHORT CASE_CONTROL CROSS_SECTIONAL ECOLOGIC FAMILY_BASED OTHER Value Aliases: `COHORT`: Cohort, cohort, Prospective cohort, Retrospective cohort `CASE_CONTROL`: Case-control, Case control, case-control `CROSS_SECTIONAL`: Cross-sectional, Cross sectional, cross-sectional
study_design_and_definition.targetEnrollment	ALWAYS	ICH M11 §10.1; SPIRIT 2013 Item 14a; CDISC SDTM TS TSPARMCD=PLANSUB	Sample Size Calculation / Statistical Methods [HIGH PRIORITY -- most authoritative] Study Design section Synopsis / Protocol Summary [MEDIUM -- may lag behind in amended protocols] Title Page [LOW -- in NIH protocols "Number" often = screening target]	Sample size Number of subjects N= Planned enrollment Enrollment target +13
Definition: The planned total number of participants to be enrolled (i.e., consented and entered into the study), NOT the number to be screened and NOT the number expected to complete (evaluable). If the protocol states different numbers for screening, enrollment, and evaluable, extract the enrollment number. Format: `Integer` Capture Guidance: Use the enrollment target, not the screening target or evaluable/completer target. In NIH protocols, the title page "Number" field often refers to the screening target -- do not use it as targetEnrollment unless confirmed by the sample size section. If the protocol provides only an evaluable target (e.g., "pilot study of 17 subjects") and adjusts for dropout (e.g., "recruit 25 to account for 15% loss"), extract 25. If the protocol contains conflicting enrollment numbers in different sections, flag the conflict per the conflict_trace_rule in _defaults. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND We plan to enroll 200 patients randomized 1:1. FOUND This will be a pilot study of 17 subjects. With 15% dropout, we need to recruit 25. We... NOT_FOUND Precis says "pilot study of 15 subjects" but Study Analysis says "pilot study of 17 subjects".
study_design_and_definition.populationAgeRange	ALWAYS	ICH M11 §5.1; SPIRIT 2013 Item 10; CDISC SDTM TS TSPARMCD=AGEMIN/AGEMAX	Study Population Synopsis Eligibility Criteria Inclusion Criteria (age requirement) Synopsis (population description) Study Population section	Age Pediatric Adult ≥18 Years old +28
Definition: Age range of the target study population. Format: `String (e.g. '18-75 years')` Capture Guidance: Extract the min-max age range from inclusion criteria. Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the populationAgeRange: Example populationAgeRange. FOUND An abbreviated or edge-case statement still identifies the populationAgeRange: Abbrev... NOT_FOUND The protocol does not explicitly state the populationAgeRange.
study_design_and_definition.therapeuticAreas	ALWAYS	ICH M11 §3; CDISC SDTM TS TSPARMCD=TAREA	Title Page Background Synopsis Title Page (disease name) Synopsis (indication) Background/Rationale	Disease area Indication Oncology Cardiology Therapeutic area +35
Definition: The broad medical/therapeutic area(s) the study addresses. Format: `Free text string or list` Capture Guidance: Identify the broad therapeutic area (e.g. 'Oncology', 'Cardiovascular'). Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the therapeuticAreas: ['Example item 1', 'Example item 2']. FOUND An abbreviated or edge-case statement still identifies the therapeuticAreas: ['Abbrev item']. NOT_FOUND The protocol does not explicitly state the therapeuticAreas.
study_design_and_definition.indication	CONDITIONAL	SPIRIT 2013; protocol synopsis	Title Page Synopsis Background/Rationale	—
Definition: The disease or condition under study (e.g. NASH, hypertension). Format: `Free text string` Extraction Boundary: Extract only the value for this field as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value.
study_design_and_definition.studyDuration	ALWAYS	ICH M11 §1.2; SPIRIT 2013 Item 14a	Synopsis (study duration statement) [HIGH — look for explicit calendar/project duration] Study Design section [MEDIUM — may state overall timeline] Study Timeline / Gantt chart [HIGH — if present] Administrative Information [LOW]	Study duration Duration of study Overall duration study duration total duration +14
Definition: Overall planned CALENDAR duration of the study from first subject first visit (FSFV) to last subject last visit (LSLV). This is the total elapsed time the study is expected to run as a project, NOT the per-participant duration. If the protocol does not explicitly state this calendar duration, set to null. Do NOT compute this by summing per-participant epoch durations (screening + treatment + follow-up) — that value belongs in participantDuration instead. Format: `String with unit (e.g. '24 months', '52 weeks', '3 years')` Capture Guidance: CRITICAL DISTINCTION: studyDuration is the total CALENDAR time the trial occupies as a project (FSFV to LSLV). participantDuration is per-individual time in the study. Many protocols state only participantDuration (sum of screening + treatment + follow-up epochs). If only per-participant duration is available and no enrollment window or overall calendar duration is stated, set studyDuration to null rather than copying participantDuration. Do NOT sum epoch durations and place the result here. Extraction Boundary: Extract only an explicitly stated overall study calendar duration. Do not derive from per-participant durations. Do not merge adjacent fields or surrounding narrative unless it directly states the overall study calendar duration. Examples: FOUND The study is expected to last approximately 36 months from first patient enrolled to... NOT_FOUND The study consists of a 4-week screening period, 52-week treatment period, and 4-week... FOUND Enrollment is expected to take 12 months. Each subject participates for approximately 6 months.
study_design_and_definition.participantDuration	ALWAYS	ICH M11 §4; SPIRIT 2013 Item 14a	Schedule of Activities Study Design Synopsis Synopsis (per-subject duration) Study Schema/Schedule Follow-up section	Subject participation Participant duration Individual participation per subject per participant +12
Definition: Duration of each individual participant's involvement from screening to final follow-up. For crossover designs, include all periods, washouts, and follow-up. State as a range if washout duration is variable. Format: `String with unit (e.g. '12 weeks')` Capture Guidance: Sum of screening + treatment + follow-up for each participant. For crossover: screening + period_1 + washout + period_2 + final_follow-up. If the protocol includes additional one-time assessments after the main study (e.g., tracer studies), include them in the total. State as a range if any component has a variable duration (e.g., washout "6-8 weeks"). Extraction Boundary: Extract only the value for participantDuration as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the participantDuration: Example participantDuration. FOUND An abbreviated or edge-case statement still identifies the participantDuration: Abbrev... NOT_FOUND The protocol does not explicitly state the participantDuration.
study_design_and_definition.screeningPeriod	COND_PROTECTED	ICH M11 §4; SPIRIT 2013 Item 13	Schedule of Activities Study Design Synopsis Synopsis (study schema) Study Design section Study Schedule/Flowchart	Screening period Lead-in Washout Screening Run-in +15
Definition: Duration of the screening/run-in period before randomization or treatment. Format: `String with unit (e.g. '28 days', '4 weeks')` Capture Guidance: Extract the screening window duration. Extraction Boundary: Extract only the value for screeningPeriod as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the screeningPeriod: Example screeningPeriod. FOUND An abbreviated or edge-case statement still identifies the screeningPeriod: Abbrev... NOT_FOUND The protocol does not explicitly state the screeningPeriod.
study_design_and_definition.treatmentPeriod	ALWAYS	ICH M11 §4; SPIRIT 2013 Item 13	Schedule of Activities Study Design Synopsis Study Design section Dosing Schedule Study Schema	Active treatment Treatment duration On-treatment Treatment period treatment period +13
Definition: Duration of the active treatment period. For crossover designs, report the per-period treatment duration. If the study drug is administered beyond the nominal treatment period (e.g., continued during post-treatment testing), report the nominal treatment duration and note the total drug administration duration in evidence. Format: `String with unit (e.g. '12 weeks', '6 cycles')` Capture Guidance: Duration of active intervention administration per treatment period. Distinguish between: (a) the treatment period as a study epoch (e.g., "7 days of treatment"), and (b) total drug administration duration if drug is continued beyond the treatment epoch for testing purposes (e.g., "9 days total drug administration"). For crossover designs: report per-period, not summed across periods. Extraction Boundary: Extract only the value for treatmentPeriod as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND Subjects receive treatment for 12 weeks. FOUND Seven days of treatment. Drug continued until completion of post-treatment testing on... NOT_FOUND The protocol does not explicitly state the treatmentPeriod.
study_design_and_definition.followUpPeriod	COND_PROTECTED	ICH M11 §4; SPIRIT 2013 Item 13	Schedule of Activities Study Design Synopsis Study Design section Safety Follow-up section Study Schema	Follow-up period Safety follow-up Post-treatment Follow-up follow-up +13
Definition: Duration of the post-treatment follow-up period, measured from the last dose of study drug to the final follow-up visit. Do not confuse study day numbers with elapsed time from last dose. For crossover designs, report the per-period follow-up duration. Format: `String with unit (e.g. '30 days', '12 weeks')` Capture Guidance: Period after last dose until final study visit. CAUTION: If the protocol uses study day numbers (e.g., "follow-up on Day 33"), calculate the elapsed time from last dose rather than using the day number directly. Example: drug ends Day 12, follow-up is Day 33 -> follow-up period = 21 days, NOT 33 days. Extraction Boundary: Extract only the value for followUpPeriod as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND Follow-up visits at 30 and 90 days after last dose. FOUND Drug stops Day 12. Safety visits Day 19 and Day 33. NOT_FOUND This protocol section indicates the followUpPeriod does not apply.
study_design_and_definition.primaryCompletionType	COND_PROTECTED	ICH M11 §4; CDISC SDTM TS TSPARMCD=PCMPLT	Statistical Considerations Study Design Synopsis Study Design (completion definition) Endpoints section Statistical Analysis Plan reference	Primary analysis LSLV Last subject last visit Primary completion primary completion +7
Definition: What defines primary completion of the study. Format: `Free text` Capture Guidance: Describe what constitutes primary completion (e.g. 'last subject completes Week 12'). Extraction Boundary: Extract only the value for primaryCompletionType as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the primaryCompletionType: Example primaryCompletionType. FOUND An abbreviated or edge-case statement still identifies the primaryCompletionType:... NOT_FOUND This protocol section indicates the primaryCompletionType does not apply for this study design.
study_design_and_definition.interimAnalysis	CONDITIONAL	ICH E9 section 4.5; ICH M11 section 10; CDISC SDTM TS TSPARMCD=INTMDANL	Study Analysis / Statistical Methods Data Monitoring section Study Design Sample Size section	Interim analysis Interim Futility Efficacy stopping Early stopping +9
Definition: Whether the study includes a pre-specified interim analysis, including timing, purpose, and decision rules. Format: `Free text` Capture Guidance: Extract the pre-specified interim analysis plan including: (1) timing, (2) purpose, (3) decision rules/stopping boundaries, (4) who is unblinded, (5) impact on sample size or analysis if triggered. Extraction Boundary: Extract the interim analysis plan if one is described. Include timing, purpose, decision criteria, and who has access to unblinded data. Do not extract ad hoc or post-hoc analysis plans. Examples: FOUND Interim analysis after first 6 subjects to assess HPA axis activation. If UFC >= 2x... NOT_FOUND The protocol does not describe an interim analysis.
study_design_and_definition.screeningTarget	CONDITIONAL	CDISC SDTM TS TSPARMCD=PLANSUB (when qualified as screening)	Title Page (Number field in NIH protocols) Sample Size section Study Design	Screen Screening Screened screen approximately plan to screen +3
Definition: The planned number of participants to be screened for eligibility. Distinct from targetEnrollment (enrolled) and evaluable target (completers). Format: `Integer` Capture Guidance: Extract the planned screening number. In NIH intramural protocols, the "Number" on the title page typically refers to the screening target. Extraction Boundary: Extract the screening number only. Do not confuse with enrollment or evaluable targets. Examples: FOUND We plan to screen approximately 80 patients. FOUND "Number: 80" on title page, with "recruit 25" in analysis section. NOT_FOUND The protocol does not state a screening target.
study_design_and_definition.maskingRoles	CONDITIONAL	ICH M11 §4.4; SPIRIT 2013 Item 11b; CDISC SDTM TS...	Study Design (masking/blinding section) Section 9 (Statistical Analysis Plan - Blinding) Synopsis (study design descriptor) Randomization and Blinding section	blinded masked blinding masking observer-blind +14
Definition: List of parties/roles that are blinded (masked) in the study. Captures the specific roles masked, providing granularity that blindingSchema (enum) alone cannot express. Required by ClinicalTrials.gov, USDM, and ICH M11. Format: `List of strings` Capture Guidance: Extract each blinded role explicitly named in the protocol. Map terms to the allowed values using the alias list. "Study staff" maps to CARE_PROVIDER. "Site monitors" maps to MONITOR. If the protocol says "all study personnel are blinded," list INVESTIGATOR, CARE_PROVIDER, MONITOR, and SPONSOR. Always cross-reference with blindingSchema: if blindingSchema = SINGLE but maskingRoles lists 4+ parties, note the discrepancy in reasoning_summary. NEW in v3.3: Also capture ADVISORY BLINDING — when the protocol states a party "should preferably be unaware" or "is encouraged to remain blinded", include that role with a note in reasoning_summary prefixed with "ADVISORY:". For SPONSOR: if the protocol describes an internal safety committee that operates under blinding (e.g., "may recommend unblinding"), this implies sponsor-level blinding and SPONSOR should be included. For ASSESSOR: treadmill technicians, endpoint assessors, central readers, or any personnel evaluating outcomes who are described as blinded (even advisorily) should be included as ASSESSOR. Extraction Boundary: Extract only the parties explicitly stated as blinded in the protocol. Do not infer blinding of additional parties. If the protocol uses a blanket statement (e.g., "all study personnel"), list all standard roles that would be covered. Do not extract the blinding mechanism here — that goes in studyTypeMasking. Examples: FOUND The investigator, study staff, study participants, site monitors, and Sponsor... FOUND This is a double-blind study; participants and investigators are blinded. FOUND Observer-blind study. The investigator is blinded. Allowed Values: PARTICIPANT INVESTIGATOR ASSESSOR CARE_PROVIDER STATISTICIAN SPONSOR MONITOR OUTCOMES_ASSESSOR OTHER Value Aliases: `PARTICIPANT`: Subject, subject, Patient, patient, Participant, participant `INVESTIGATOR`: Investigator, investigator, Physician, PI, Principal Investigator, Study physician, Treating physician `ASSESSOR`: Assessor, assessor, Outcome assessor, Endpoint assessor, Independent assessor, Central reader, Adjudicator, Treadmill technician, Exercise technician, Test technician `CARE_PROVIDER`: Care provider, care provider, Nurse, Study nurse, Clinical staff, Study staff, Site staff `STATISTICIAN`: Statistician, statistician, Biostatistician, Statistical team `SPONSOR`: Sponsor, sponsor, Sponsor personnel, Sponsor staff, Sponsor team, CRO, Contract research organization `MONITOR`: Monitor, monitor, Site monitor, Clinical monitor, Study monitor, CRA `OUTCOMES_ASSESSOR`: Outcomes assessor, outcomes assessor, Endpoint adjudicator, Central reviewer `OTHER`: Other, other
study_design_and_definition.primaryEstimand	CONDITIONAL	ICH E9(R1); ICH M11 §3	Objectives and Estimands section Section 3.1 or equivalent Statistical Considerations Statistical Analysis section (for pre-E9(R1) protocols)	estimand intercurrent event treatment policy composite strategy hypothetical strategy +10
Definition: The primary estimand as defined per the ICH E9(R1) framework, including the treatment condition, endpoint variable, population of interest, intercurrent event strategies, and population-level summary measure. For older protocols (pre-2020) that describe estimand concepts without formal E9(R1) terminology, extract the equivalent components using the protocol's own terminology. Format: `Free text (structured paragraph)` Capture Guidance: Extract the full estimand as defined in the protocol. Modern protocols (post-2020) increasingly use the formal ICH E9(R1) framework with explicit estimand sections. Older protocols (pre-2020) may describe estimand-equivalent concepts without using the term 'estimand'. Look for: (a) 'de jure' / 'de facto' language (common in Lilly and some FDA-requested protocols), (b) 'efficacy estimand' vs 'treatment-regimen estimand', (c) descriptions of how rescue medication, treatment discontinuation, and missing data are handled differently across co-primary analyses. If such concepts are present, extract them as estimand components even without formal E9(R1) labels. If neither formal estimands nor equivalent concepts are described, set to null. Extraction Boundary: Extract the complete primary estimand definition from the estimands section (typically Section 3.1 or equivalent). Capture all five components: treatment condition, variable/endpoint, population, intercurrent event strategies, and summary measure. Do not substitute the endpoint description alone for the full estimand. For protocols without formal estimand sections, look for equivalent descriptions in the Statistical Considerations section, particularly descriptions of how rescue medication, treatment discontinuation, and missing data are handled in the primary analysis. Examples: FOUND Primary estimand: Treatment ratio of semaglutide vs placebo in ratio to baseline at... FOUND Two primary estimands: an efficacy estimand (de jure effect) using data before rescue... NOT_FOUND The protocol does not define a formal estimand framework.
study_design_and_definition.dataMonitoringCommittee	ALWAYS	ICH M11 §9.7; SPIRIT 2013 Item 21b	Synopsis (Data monitoring committee) Section 9 Statistical Considerations Section 10 Supporting Documentation Committees Structure	data monitoring committee DMC DSMB data safety monitoring board independent monitoring +1
Definition: The name or type of the independent monitoring body overseeing study safety (e.g., Data Safety Monitoring Board, Data Monitoring Committee, Safety Review Committee). Format: `Free text string` Capture Guidance: Extract the actual name or type of the oversight committee (e.g., 'Independent Data Safety Monitoring Board (DSMB)', 'Data Monitoring Committee', 'Safety Review Committee'). Do not return YES/NO or True/False — those belong in the boolean presence field. If the protocol mentions a DMC/DSMB exists but does not name it, return 'Data Monitoring Committee' as a reasonable default. Return NOT_FOUND only if the protocol does not mention any independent monitoring body. Extraction Boundary: Extract only whether a DMC/DSMB is used. Do not extract the committee's charter or operational details here. Examples: FOUND An independent DSMB will review unblinded safety data quarterly. FOUND A Safety Review Committee (SRC) will convene after every 10 patients. NOT_FOUND The protocol does not mention a data monitoring committee.
study_design_and_definition.rescueTherapy	CONDITIONAL	ICH M11 §4; ICH E9(R1) intercurrent events	Rescue Therapy section Concomitant Medication section Treatment section Section 6 or equivalent	rescue therapy rescue medication rescue treatment revascularisation breakthrough therapy
Definition: Description of rescue medications or procedures permitted during the trial, including the trigger criteria and how rescue is handled in the analysis. Format: `Free text` Capture Guidance: Rescue therapy is important for estimand interpretation (intercurrent events). Extract the full rescue definition including permitted medications, procedures, dose thresholds, and patient management after rescue. Extraction Boundary: Extract the permitted rescue therapies and their triggers. Do not extract the full concomitant medication policy — only rescue-specific provisions. Examples: FOUND Rescue medication: Starting on cilostazol or increasing dose by 20% or more.... NOT_FOUND The protocol does not define rescue therapy provisions.
study_design_and_definition.doseEscalationSchema	CONDITIONAL	ICH M11 §4.3; ICH E4	Treatment section (dose escalation subsection) Study Design (dose justification) Justification for Dose section Study Treatments table	dose escalation dose titration starting dose titrate step-up +8
Definition: Description of the dose escalation/titration approach used in the study, including starting dose, intermediate dose levels, escalation intervals, and criteria for escalation. Applicable when the study uses a fixed dose escalation regimen (not adaptive dose-finding). This captures the shared titration schedule across arms, not the final assigned doses (which belong in interventions.dose and arms.description). Format: `Free text (structured paragraph)` Capture Guidance: Captures the titration regimen shared across arms. Many GLP-1 RA, insulin, and oncology protocols use fixed escalation schedules that are critical for understanding time-to-full-dose exposure, GI tolerability interpretation, and safety signal analysis during escalation. Extract the complete schedule including starting dose, each intermediate step, timing, and rationale. For oncology 3+3 or rolling-six designs, extract the DLT evaluation window and escalation decision rules. Extraction Boundary: Extract the dose escalation schedule and rationale. Do not extract the final assigned dose here — that belongs in interventions.dose. Focus on the escalation mechanics: starting dose, intermediate steps, timing of each step, and whether escalation is fixed or criteria-based. Examples: FOUND All patients start at 0.75 mg QW for 4 weeks, then 1.5 mg QW for 4 weeks. At Week 8,... FOUND Dose escalation per Figure 1 (no textual description of dose levels). NOT_FOUND Protocol does not use dose escalation.
study_design_and_definition.hyperglycemiaRescueCriteria	CONDITIONAL	ICH E9(R1) intercurrent events; ADA Standards of Care	Concomitant Medication section Special Treatment Considerations Hyperglycemia Management section Management of Severe/Persistent Hyperglycemia section	persistent hyperglycemia rescue criteria FPG threshold HbA1c threshold glycemic rescue +5
Definition: Time-varying rescue therapy trigger criteria for studies in diabetes or metabolic disease. Captures the specific quantitative thresholds (e.g., FPG, HbA1c) and time windows that trigger rescue medication initiation. This is separate from the rescue medication hierarchy (captured in rescueTherapy) — this field captures WHEN rescue is triggered, not WHAT rescue is given. Format: `Free text (structured paragraph)` Capture Guidance: Specific to diabetes/metabolic disease trials. Time-varying thresholds are common and clinically important for estimand interpretation (intercurrent events). Extract all threshold tiers with their time windows and minimum data requirements. These criteria define an intercurrent event (rescue) that affects estimand interpretation. Extraction Boundary: Extract only the quantitative trigger criteria and time windows. Do not extract the rescue medication hierarchy here — that goes in rescueTherapy. Focus on the FPG/HbA1c thresholds, the time periods they apply to, and the minimum data requirements (e.g., '4 values/week over 2 weeks'). Examples: FOUND Rescue criteria: (a) Weeks 0-8: average FPG >270 mg/dL over ≥2 weeks. (b) Weeks 8-18:... NOT_FOUND Protocol does not define hyperglycemia rescue criteria.

Arms

11 fields

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Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
arms.armId	SYSTEM	CDISC SDTM TA ARMCD; ICH M11 §4.2	Study Design Arms Study Arms table/section SoA headers Synopsis	Arm ID Arm code Arm Group Cohort +3
Definition: Unique identifier for this study arm. Format: `String` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for armId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the armId.
arms.armName	ALWAYS	ICH M11 §4.2; SPIRIT 2013 Item 8; CDISC SDTM TA ARM	Study Design Arms Synopsis Study Arms table Study Design narrative SoA headers	Treatment arm Arm Treatment group Group Arm Name +5
Definition: The descriptive name assigned to the study arm. Format: `Free text string` Capture Guidance: Use the exact arm name from the protocol. Extraction Boundary: Extract only the value for armName as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the armName: Example armName. FOUND An abbreviated or edge-case statement still identifies the armName: Abbrev armName. NOT_FOUND The protocol does not explicitly state the armName.
arms.armType	CONDITIONAL	ICH M11 §4.2; SPIRIT 2013 Item 8	Study Design Arms Synopsis Study Arms table type column Arm header/label Study Design narrative	No intervention Sham Experimental Placebo comparator Active comparator +4
Definition: The functional role of the arm within the study design. Format: `Enum string` Capture Guidance: Infer from arm description. Investigational drug arm -> EXPERIMENTAL. Matched placebo arm -> PLACEBO_COMPARATOR. Active marketed drug -> ACTIVE_COMPARATOR. No intervention or observation only -> NO_INTERVENTION. Extraction Boundary: Extract only the value for armType as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the armType: EXPERIMENTAL. FOUND An abbreviated or edge-case statement still identifies the armType: ACTIVE_COMPARATOR. NOT_FOUND This protocol section indicates the armType does not apply for this study design. Allowed Values: EXPERIMENTAL ACTIVE_COMPARATOR PLACEBO_COMPARATOR SHAM_COMPARATOR NO_INTERVENTION OTHER Value Aliases: `EXPERIMENTAL`: Experimental, experimental, Treatment, Investigational, Active treatment, Study drug, Test `ACTIVE_COMPARATOR`: Active Comparator, Active comparator, active comparator, Active control, Comparator, Reference `PLACEBO_COMPARATOR`: Placebo Comparator, Placebo comparator, placebo comparator, Placebo, Placebo control, Matching placebo `SHAM_COMPARATOR`: Sham Comparator, Sham comparator, sham comparator, Sham, Sham control `NO_INTERVENTION`: No Intervention, No intervention, no intervention, Observation, No treatment, Untreated
arms.description	ALWAYS	ICH M11 §4.2; SPIRIT 2013 Item 11a	Interventions Study Design Arms Study Arms table description column Arm narrative text Study Design section	Treatment description Arm description Description Participants receive Treatment consists of +2
Definition: Detailed description of the arm including intervention, dose, schedule, and route. Format: `Free text` Capture Guidance: Provide a concise description of each arm including intervention, dose, route, frequency, and any add-on therapy. For dose escalation, include only dose levels explicitly stated in the protocol text. Do not infer specific escalation dose levels from the approved product label. If dose escalation details are only in a figure, note 'dose escalation per Figure X' without specifying inferred dose levels. Extraction Boundary: Extract the arm-level narrative describing what participants in the arm receive or experience. Do not split out standalone intervention records or dose details unless they are part of the arm description verbatim. Examples: FOUND The protocol explicitly states the description: Example description. FOUND An abbreviated or edge-case statement still identifies the description: Abbrev description. NOT_FOUND The protocol does not explicitly state the description.
arms.interventions	ALWAYS	ICH M11 §4.3	Study Design Interventions Arms Interventions/Study Treatment section Study Arms table SoA treatment columns	Treatment Intervention Drug Dose Intervention(s) +5
Definition: Name(s) or reference(s) to the interventions assigned to this arm. Format: `Free text or list of strings` Capture Guidance: List intervention(s) for this arm. May have multiple for combination therapy. Extraction Boundary: Extract only the intervention names or identifiers linked to the arm. Do not copy the full descriptive narrative of the arm or dose regimen text. Examples: FOUND The protocol explicitly states the interventions: ['Example item 1', 'Example item 2']. FOUND An abbreviated or edge-case statement still identifies the interventions: ['Abbrev item']. NOT_FOUND The protocol does not explicitly state the interventions.
arms.sampleSize	CONDITIONAL	ICH M11 §10.1; SPIRIT 2013 Item 14a	Statistical Considerations Arms Synopsis Study Arms table N column Statistical section Study Design allocation	Arm size Per group N per arm Per arm N= +4
Definition: The planned number of participants in this arm. Format: `Integer` Capture Guidance: May need calculation from total enrollment and randomization ratio. Extraction Boundary: Extract only the value for sampleSize as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the sampleSize: Example sampleSize. FOUND An abbreviated or edge-case statement still identifies the sampleSize: Abbrev sampleSize. NOT_FOUND This protocol section indicates the sampleSize does not apply for this study design.
arms.treatmentDuration	CONDITIONAL	ICH M11 §4.3; SPIRIT 2013 Item 11a	Interventions Study Design Arms Study Arms table duration column Study Design narrative SoA epoch mapping	Treatment duration Weeks Cycles Duration of treatment Duration +4
Definition: Duration of treatment for participants in this arm. Format: `String with unit (e.g. '12 weeks')` Capture Guidance: Extract arm-specific duration if different from overall treatment period. Extraction Boundary: Extract only the value for treatmentDuration as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the treatmentDuration: Example treatmentDuration. FOUND An abbreviated or edge-case statement still identifies the treatmentDuration: Abbrev... NOT_FOUND This protocol section indicates the treatmentDuration does not apply for this study design.
arms.sequenceCrossover	CONDITIONAL	ICH M11 §4.2; ICH E9 §2.3.4	Study Design Arms Crossover/sequence diagram Study Design narrative SoA crossover section	Crossover sequence BA Treatment order Sequence AB +3
Definition: For crossover designs, the treatment sequence this arm follows. Format: `String (e.g. 'A→B', 'B→A')` Capture Guidance: Only relevant for crossover designs. Extraction Boundary: Extract only the value for sequenceCrossover as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the sequenceCrossover: Example sequenceCrossover. FOUND An abbreviated or edge-case statement still identifies the sequenceCrossover: Abbrev... NOT_FOUND This protocol section indicates the sequenceCrossover does not apply for this study design.
arms.notes	OPTIONAL	Internal	Study Design Arms Footnotes under arms table Study Design notes SoA footnotes	Note Footnote Stratified Additional Comment
Definition: Additional notes or assumptions about this arm. Format: `Free text` Capture Guidance: Capture arm-specific caveats, footnotes, or assumptions. Extraction Boundary: Extract only the value for notes as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the notes: Example notes. FOUND An abbreviated or edge-case statement still identifies the notes: Abbrev notes. NOT_FOUND This protocol section indicates the notes does not apply for this study design.
arms.pageNumber	ALWAYS	Internal — auto-populated	Captured during extraction from source location	p. page pp.
Definition: Page number where arm information was found. Format: `Integer` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageNumber: Example pageNumber. FOUND An abbreviated or edge-case statement still identifies the pageNumber: Abbrev pageNumber. NOT_FOUND The protocol does not explicitly state the pageNumber.
arms.pageSection	ALWAYS	Internal — auto-populated	Captured during extraction use section heading/table title	Section Table Study Arms Study Design
Definition: Section heading where arm information was found. Format: `Free text` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageSection as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageSection: Example pageSection. FOUND An abbreviated or edge-case statement still identifies the pageSection: Abbrev pageSection. NOT_FOUND The protocol does not explicitly state the pageSection.

Activities

21 fields

▼

Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
activities.activityId	SYSTEM	CDISC Protocol Representation Model; ICH M11 §5	Schedule of Activities N/A (System) or Activities list/table	Activity ID Procedures Assessments Schedule of Events
Definition: Unique identifier for this activity record. Format: `String` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for activityId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the activityId.
activities.activityName	ALWAYS	ICH M11 §5; SPIRIT 2013 Item 11a	Schedule of Activities Study Procedures Schedule of Events / Procedures	Test Activity Examination Procedure Assessment +3
Definition: The name of the study activity or procedure. Format: `Free text string` Capture Guidance: Use the activity name as listed in the SoA table. Extraction Boundary: Extract only the value for activityName as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the activityName: Example activityName. FOUND An abbreviated or edge-case statement still identifies the activityName: Abbrev activityName. NOT_FOUND The protocol does not explicitly state the activityName.
activities.activityLabel	OPTIONAL	ICH M11 §5	Schedule of Activities SOE column labels	Abbreviation Short name Label abbreviations (ECG PE +1
Definition: REPEATING FIELD: return one value per activity row in the SoA table. A short display label for the activity, typically used in SoA column headers. Format: `Free text string (array — one per parent entity)` Capture Guidance: Shorter form of activityName used in tables or displays. Extraction Boundary: Extract only the value for activityLabel as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the activityLabel: Example activityLabel. FOUND An abbreviated or edge-case statement still identifies the activityLabel: Abbrev activityLabel. NOT_FOUND This protocol section indicates the activityLabel does not apply for this study design.
activities.description	ALWAYS	ICH M11 §5; SPIRIT 2013 Item 11a	Schedule of Activities Study Procedures Activity narrative / footnotes	Procedure description Activity description includes performed
Definition: REPEATING FIELD: return one value per activity row in the SoA table. Detailed description of the activity including what it involves and its purpose. Format: `Free text (array — one per parent entity)` Capture Guidance: Provide enough detail to distinguish this activity from similar ones. Extraction Boundary: Extract only the value for description as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the description: Example description. FOUND An abbreviated or edge-case statement still identifies the description: Abbrev description. NOT_FOUND The protocol does not explicitly state the description.
activities.dataType	CONDITIONAL	CDISC Protocol Representation Model	Schedule of Activities Study Procedures Tables stating type	Data type Numeric Text Categorical numeric +2
Definition: REPEATING FIELD: return one value per activity row in the SoA table. The type of data collected by this activity. Format: `Free text (e.g. 'Numeric', 'Categorical') (array — one per parent entity)` Capture Guidance: Classify the data type (lab value=Numeric, AE term=Text, etc.). Extraction Boundary: Extract only the value for dataType as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the dataType: Example dataType. FOUND An abbreviated or edge-case statement still identifies the dataType: Abbrev dataType. NOT_FOUND This protocol section indicates the dataType does not apply for this study design.
activities.collectionMethod	OPTIONAL	ICH M11 §5; SPIRIT 2013 Item 18	Schedule of Activities Study Procedures Procedures / assessments text	eCRF Collection method ePRO Local lab Central lab +4
Definition: REPEATING FIELD: return one value per activity row in the SoA table. How the activity data is collected (e.g. central lab, eCRF, ePRO). Format: `Free text (array — one per parent entity)` Capture Guidance: Describe the collection mechanism for this activity. Extraction Boundary: Extract only the value for collectionMethod as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the collectionMethod: Example collectionMethod. FOUND An abbreviated or edge-case statement still identifies the collectionMethod: Abbrev... NOT_FOUND This protocol section indicates the collectionMethod does not apply for this study design.
activities.specimenType	CONDITIONAL	ICH M11 §5; CDISC SDTM LB	Schedule of Activities Study Procedures Lab/Specimen description	Plasma CSF Urine Specimen Biopsy +6
Definition: REPEATING FIELD: return one value per activity row in the SoA table. Type of biological specimen collected for this activity (if applicable). Format: `Free text (array — one per parent entity)` Capture Guidance: Specify the specimen type (e.g. 'Venous blood', 'Spot urine'). Extraction Boundary: Extract only the value for specimenType as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the specimenType: Example specimenType. FOUND An abbreviated or edge-case statement still identifies the specimenType: Abbrev specimenType. NOT_FOUND This protocol section indicates the specimenType does not apply for this study design.
activities.frequency	OPTIONAL	ICH M11 §5; SPIRIT 2013 Item 13	Schedule of Activities Study Procedures SOE frequency row/column	Frequency Monthly At each visit Every Weekly +4
Definition: REPEATING FIELD: return one value per activity row in the SoA table. How often the activity is performed during the study. Format: `Free text (e.g. 'Every 4 weeks') (array — one per parent entity)` Capture Guidance: Describe the frequency pattern from the SoA table. Extraction Boundary: Extract only the value for frequency as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the frequency: Example frequency. FOUND An abbreviated or edge-case statement still identifies the frequency: Abbrev frequency. NOT_FOUND This protocol section indicates the frequency does not apply for this study design.
activities.units	CONDITIONAL	CDISC SDTM	Schedule of Activities Study Procedures Vital signs / lab tables	mg/dL mm Hg mmol/L Units mmHg +3
Definition: REPEATING FIELD: return one value per activity row in the SoA table. Units of measurement for the activity results. Format: `Free text (e.g. 'mg/dL') (array — one per parent entity)` Capture Guidance: Standard SI or conventional units. Extraction Boundary: Extract only the value for units as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the units: Example units. FOUND An abbreviated or edge-case statement still identifies the units: Abbrev units. NOT_FOUND This protocol section indicates the units does not apply for this study design.
activities.normalRange	CONDITIONAL	ICH M11 §5; CDISC SDTM	Safety Monitoring Study Procedures Lab criteria / thresholds	Normal range ULN Reference range LLN range +3
Definition: REPEATING FIELD: return one value per activity row in the SoA table. Normal or reference range for the activity measurement. Format: `Free text (e.g. '3.5-5.0 mmol/L') (array — one per parent entity)` Capture Guidance: Extract if stated; often deferred to central lab manual. Extraction Boundary: Extract only the value for normalRange as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the normalRange: Example normalRange. FOUND An abbreviated or edge-case statement still identifies the normalRange: Abbrev normalRange. NOT_FOUND This protocol section indicates the normalRange does not apply for this study design.
activities.assumption	OPTIONAL	Internal	N/A (Documentation)	assume inferred
Definition: Assumptions made about this activity during extraction. Format: `Free text` Capture Guidance: Document assumptions when the protocol is ambiguous. Extraction Boundary: Extract only the value for assumption as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the assumption: Example assumption. FOUND An abbreviated or edge-case statement still identifies the assumption: Abbrev assumption. NOT_FOUND This protocol section indicates the assumption does not apply for this study design.
activities.notes	OPTIONAL	Internal	Schedule of Activities Footnotes/caveats	optional footnote
Definition: Additional notes about this activity. Format: `Free text` Capture Guidance: Capture footnotes or additional context from the SoA. Extraction Boundary: Extract only the value for notes as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the notes: Example notes. FOUND An abbreviated or edge-case statement still identifies the notes: Abbrev notes. NOT_FOUND This protocol section indicates the notes does not apply for this study design.
activities.pageNumber	ALWAYS	Internal — auto-populated	Page footer/header	p. pp.
Definition: Page number where activity information was found. Format: `Integer` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageNumber: Example pageNumber. FOUND An abbreviated or edge-case statement still identifies the pageNumber: Abbrev pageNumber. NOT_FOUND The protocol does not explicitly state the pageNumber.
activities.pageSection	ALWAYS	Internal — auto-populated	Section header	section titles
Definition: Section heading where activity information was found. Format: `Free text` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageSection as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageSection: Example pageSection. FOUND An abbreviated or edge-case statement still identifies the pageSection: Abbrev pageSection. NOT_FOUND The protocol does not explicitly state the pageSection.
activities.activityCategory	ALWAYS	ICH M11 §6 (Schedule of Activities); CDISC SDTM TA/TV	SOA table Schedule of Activities row group header	category group section header
Definition: Category grouping for the activity row in the Schedule of Activities table. Format: `Controlled term (SAFETY, EFFICACY, PK, PD, BIOMARKER, ADMINISTRATIVE)` Extraction Boundary: Extract only the value for activityCategory as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the activityCategory: Example activityCategory. FOUND An abbreviated or edge-case statement still identifies the activityCategory: Abbrev... NOT_FOUND The protocol does not explicitly state the activityCategory.
activities.activityProcedure	ALWAYS	ICH M11 §6; SPIRIT 2013 Item 13	SOA table row labels procedure names	procedure assessment test sample
Definition: The procedure or activity name from the SOA row label. Format: `Free text` Extraction Boundary: Extract only the value for activityProcedure as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the activityProcedure: Example activityProcedure. FOUND An abbreviated or edge-case statement still identifies the activityProcedure: Abbrev... NOT_FOUND The protocol does not explicitly state the activityProcedure.
activities.assumptionNotes	CONDITIONAL	Internal — extraction provenance	SOA table footnotes protocol text	—
Definition: REPEATING FIELD: return one value per activity row in the SoA table. Extraction assumptions or notes about this SOA activity row. Format: `string (array — one per parent entity)` Extraction Boundary: Extract only the value for assumptionNotes as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the assumptionNotes: Example assumptionNotes. FOUND An abbreviated or edge-case statement still identifies the assumptionNotes: Abbrev... NOT_FOUND This protocol section indicates the assumptionNotes does not apply for this study design.
activities.footnoteMarkersUsed	CONDITIONAL	ICH M11 §6; SPIRIT 2013 Figure	SOA table cells superscript markers	footnote superscript * †
Definition: REPEATING FIELD: return one value per activity row in the SoA table. Footnote marker symbols (e.g., , a, 1) used in this SOA row. Format:* `Comma-separated list of markers (array — one per parent entity)` Extraction Boundary: Extract only the value for footnoteMarkersUsed as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the footnoteMarkersUsed: ['Example item 1', 'Example item 2']. FOUND An abbreviated or edge-case statement still identifies the footnoteMarkersUsed:... NOT_FOUND This protocol section indicates the footnoteMarkersUsed does not apply for this study design.
activities.footnoteText	CONDITIONAL	ICH M11 §6	SOA table footer footnotes section	footnote note
Definition: REPEATING FIELD: return one value per activity row in the SoA table. Full text of footnotes associated with this SOA activity row. Format: `Free text (array — one per parent entity)` Extraction Boundary: Extract only the value for footnoteText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the footnoteText: Example footnoteText. FOUND An abbreviated or edge-case statement still identifies the footnoteText: Abbrev footnoteText. NOT_FOUND This protocol section indicates the footnoteText does not apply for this study design.
activities.visitHeaderText	CONDITIONAL	ICH M11 §6; SPIRIT 2013 Figure	SOA table column headers visit names	—
Definition: Column header text for visit columns in the SOA table. Format: `Free text (visit label)` Extraction Boundary: Extract only the value for visitHeaderText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the visitHeaderText: Example visitHeaderText. FOUND An abbreviated or edge-case statement still identifies the visitHeaderText: Abbrev... NOT_FOUND This protocol section indicates the visitHeaderText does not apply for this study design.
activities.visitScheduleText	ALWAYS	ICH M11 §6; SPIRIT 2013 Figure	SOA table cells X marks checkmarks	—
Definition: REPEATING FIELD: return one value per activity row in the SoA table. Cell content indicating whether activity is performed at each visit (X, ✓, conditional text). Format: `Cell content (X, ✓, text, or empty) (array — one per parent entity)` Extraction Boundary: Extract only the value for visitScheduleText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the visitScheduleText: Example visitScheduleText. FOUND An abbreviated or edge-case statement still identifies the visitScheduleText: Abbrev... NOT_FOUND The protocol does not explicitly state the visitScheduleText.

Crossover Design

13 fields

▼

Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
crossover_design.sequenceId	SYSTEM	CDISC SDTM TA; ICH M11 §4.2	Study Design Crossover Design section Sequence table header	Sequence ID Sequence Seq AB/BA Group +1
Definition: Unique identifier for this crossover sequence record. Format: `String` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for sequenceId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the sequenceId.
crossover_design.sequenceName	CONDITIONAL	ICH M11 §4.2; ICH E9 §2.3.4	Study Design Crossover Design section Sequence table	Sequence Sequence name Treatment sequence Group Treatment Arm +1
Definition: Descriptive name of the crossover sequence. Format: `Free text string` Capture Guidance: E.g. 'Sequence AB', 'Sequence BA'. Extraction Boundary: Extract only the value for sequenceName as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the sequenceName: Example sequenceName. FOUND An abbreviated or edge-case statement still identifies the sequenceName: Abbrev sequenceName. NOT_FOUND The protocol does not explicitly state the sequenceName.
crossover_design.sequencePattern	CONDITIONAL	ICH M11 §4.2; ICH E9 §2.3.4	Study Design Crossover Design section Randomization table	Pattern Treatment order B→A ABC A→B +5
Definition: The ordered pattern of treatments in this sequence. Format: `String (e.g. 'A→B→A', 'Drug→Placebo')` Capture Guidance: Describe the exact order of interventions in this sequence. Extraction Boundary: Extract only the value for sequencePattern as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the sequencePattern: Example sequencePattern. FOUND An abbreviated or edge-case statement still identifies the sequencePattern: Abbrev... NOT_FOUND The protocol does not explicitly state the sequencePattern.
crossover_design.description	CONDITIONAL	ICH M11 §4.2; ICH E9 §2.3.4	Study Design Synopsis Crossover Design section Study Design narrative	Crossover Cross-over Crossover design sequence crossover +2
Definition: Detailed description of the crossover design including rationale. Format: `Free text` Capture Guidance: Describe the crossover scheme and its rationale. Extraction Boundary: Extract only the value for description as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the description: Example description. FOUND An abbreviated or edge-case statement still identifies the description: Abbrev description. NOT_FOUND The protocol does not explicitly state the description.
crossover_design.numberOfPeriods	OPTIONAL	ICH M11 §4.2; ICH E9 §2.3.4	Study Design Study Design section Crossover description	Period Number of periods Treatment period period 2-period +3
Definition: The number of treatment periods in the crossover design. Format: `Integer` Capture Guidance: Count distinct treatment periods. A 2×2 crossover has 2 periods. Extraction Boundary: Extract only the value for numberOfPeriods as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the numberOfPeriods: Example numberOfPeriods. FOUND An abbreviated or edge-case statement still identifies the numberOfPeriods: Abbrev... NOT_FOUND This protocol section indicates the numberOfPeriods does not apply for this study design.
crossover_design.periodInterventions	CONDITIONAL	ICH M11 §4.2	Study Design Interventions Crossover table Sequence description	Period 2 Treatment B Treatment A Period 1 followed by +2
Definition: The intervention(s) administered in each period of this sequence. Format: `List or structured text` Capture Guidance: Map each period to its intervention (e.g. 'Period 1: Drug A, Period 2: Drug B'). Extraction Boundary: Extract only the value for periodInterventions as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the periodInterventions: ['Example item 1', 'Example item 2']. FOUND An abbreviated or edge-case statement still identifies the periodInterventions:... NOT_FOUND The protocol does not explicitly state the periodInterventions.
crossover_design.washoutDuration	OPTIONAL	ICH M11 §4.2; ICH E9 §2.3.4	Schedule of Activities Study Design Washout section Crossover description	Washout Rest period Washout period Carryover washout +6
Definition: Duration of the washout period between treatment periods. Format: `String with unit (e.g. '2 weeks', '5 half-lives')` Capture Guidance: Extract the explicit washout duration between treatment periods. If stated as a range (e.g., "at least 6 and no more than 8 weeks"), extract the range: "6-8 weeks". Extraction Boundary: Extract only the value for washoutDuration as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the washoutDuration: Example washoutDuration. FOUND An abbreviated or edge-case statement still identifies the washoutDuration: Abbrev... NOT_FOUND This protocol section indicates the washoutDuration does not apply for this study design.
crossover_design.randomizationRatio	OPTIONAL	ICH M11 §4.5; SPIRIT 2013 Item 16a	Study Design Randomization section	Randomization ratio 1:1 Allocation ratio ratio 2:1 +2
Definition: Randomization ratio for assigning participants to sequences. Format: `String (e.g. '1:1')` Capture Guidance: Ratio of participants across sequences. Extraction Boundary: Extract only the value for randomizationRatio as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the randomizationRatio: Example randomizationRatio. FOUND An abbreviated or edge-case statement still identifies the randomizationRatio: Abbrev... NOT_FOUND This protocol section indicates the randomizationRatio does not apply for this study design.
crossover_design.blockSize	OPTIONAL	ICH M11 §4.5; ICH E9 §2.3.1	Study Design Randomization section	Permuted block Block randomization Block size block block size +2
Definition: Block size used in the randomization for sequence assignment. Format: `Integer or string` Capture Guidance: Extract block size if stated in the randomization description. Extraction Boundary: Extract only the value for blockSize as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the blockSize: Example blockSize. FOUND An abbreviated or edge-case statement still identifies the blockSize: Abbrev blockSize. NOT_FOUND This protocol section indicates the blockSize does not apply for this study design.
crossover_design.balancingFactor	OPTIONAL	ICH M11 §4.5; ICH E9 §2.3.2	Study Design Randomization section Stratification factors	Balancing Balancing factor Stratification balanced stratified +3
Definition: Factors used to balance the crossover sequence assignment. Format: `Free text or list` Capture Guidance: Any factors used to ensure balance across sequences. Extraction Boundary: Extract only the value for balancingFactor as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the balancingFactor: ['Example item 1', 'Example item 2']. FOUND An abbreviated or edge-case statement still identifies the balancingFactor: ['Abbrev item']. NOT_FOUND This protocol section indicates the balancingFactor does not apply for this study design.
crossover_design.expectedN	OPTIONAL	ICH M11 §10.1	Statistical Considerations Study Design Sample Size section	Expected enrollment Per sequence N per sequence per sequence N= +3
Definition: The expected number of evaluable subjects completing the crossover. This may differ from targetEnrollment (which includes anticipated dropouts). Format: `Integer` Capture Guidance: Extract the evaluable/completer target for the crossover design. If the protocol states different numbers in different sections, flag per the conflict_trace_rule in _defaults. Extraction Boundary: Extract only the value for expectedN as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the expectedN: Example expectedN. FOUND An abbreviated or edge-case statement still identifies the expectedN: Abbrev expectedN. NOT_FOUND This protocol section indicates the expectedN does not apply for this study design.
crossover_design.pageNumber	CONDITIONAL	Internal — auto-populated	All source locations for sequence fields	—
Definition: Page number where crossover design information was found. Format: `Integer` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageNumber: Example pageNumber. FOUND An abbreviated or edge-case statement still identifies the pageNumber: Abbrev pageNumber. NOT_FOUND The protocol does not explicitly state the pageNumber.
crossover_design.pageSection	CONDITIONAL	Internal — auto-populated	Section headers in protocol	Section Study Design Randomization Crossover
Definition: Section heading where crossover design information was found. Format: `Free text` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageSection as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageSection: Example pageSection. FOUND An abbreviated or edge-case statement still identifies the pageSection: Abbrev pageSection. NOT_FOUND The protocol does not explicitly state the pageSection.

Eligibility Criteria

13 fields

▼

Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
eligibility_criteria.criterionId	SYSTEM	ICH M11 §5.1	Eligibility Criteria N/A (System-generated)	E1 Criterion ID I1
Definition: Unique identifier for this eligibility criterion. Format: `String` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for criterionId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the criterionId.
eligibility_criteria.category	ALWAYS	ICH M11 §5.1; SPIRIT 2013 Item 10	Eligibility Criteria Section headers in eligibility section explicit labels before criteria lists	Inclusion Exclusion inclusion exclusion eligible +4
Definition: REPEATING FIELD: return one value per eligibility criterion. Whether this is an inclusion or exclusion criterion. Format: `Enum string (array — one per parent entity)` Capture Guidance: INCLUSION for criteria that must be met. EXCLUSION for disqualifying criteria. Extraction Boundary: Extract only the value for category as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the category: INCLUSION. FOUND An abbreviated or edge-case statement still identifies the category: EXCLUSION. NOT_FOUND The protocol does not explicitly state the category. Allowed Values: INCLUSION EXCLUSION Value Aliases: `INCLUSION`: Inclusion, inclusion, INCLUSION, Include, Eligible if `EXCLUSION`: Exclusion, exclusion, EXCLUSION, Exclude, Excluded if
eligibility_criteria.text	ALWAYS	ICH M11 §5.1; SPIRIT 2013 Item 10; ICH E6(R2) §4.3	Eligibility Criteria Eligibility section body bulleted/numbered lists criterion descriptions	Inclusion criteria Eligible if Exclusion criteria Must have must +8
Definition: The full text of the eligibility criterion as written in the protocol. This is a REPEATING field: extract one record per criterion. Each criterion should include its category (INCLUSION or EXCLUSION), a sequential identifier (e.g., IC-1, EC-14), and the full text. COMPLETENESS REQUIRED: extract ALL criteria from the protocol, not a selected subset of 'key' criteria. Format: `Free text. When multiple criteria exist, extract as a structured object with two arrays: 'inclusion' (all inclusion criteria) and 'exclusion' (all exclusion criteria). Each array entry is the verbatim criterion text prefixed with its identifier (e.g., 'IC-1: ...').` Capture Guidance: Preserve the exact wording from the protocol. Extract one record per numbered criterion. Assign identifiers as IC-{n} for inclusion criteria and EC-{n} for exclusion criteria, matching the protocol's numbering. COMPLETENESS: Extract ALL criteria. A typical Phase 3 protocol has 8-15 inclusion criteria and 15-40 exclusion criteria. If the extraction has significantly fewer than the protocol's count, it is incomplete. For criteria referencing appendices or external classification systems, extract the main criterion text and note the appendix reference. Extraction Boundary: Extract the criterion statement verbatim. Do not replace it with a higher-level cohort description or category label. COMPLETENESS: Extract every numbered/lettered criterion. Do not editorially select 'key' or 'most clinically significant' criteria — extract all. For criteria with complex sub-items (e.g., contraception method classifications, pregnancy definitions with sub-clauses), extract the main criterion text and abbreviate sub-items with a reference to the source section or appendix (e.g., 'see Appendix 6 for contraceptive method classification'). Examples: FOUND Inclusion Criteria: 1. Men and women 35-70 years of age. 2. BMI 25-37 kg/m2. FOUND Inclusion Criteria: [1] T2D for ≥6 months. [2] Age ≥18. [3] HbA1c ≥7.5% and ≤11.0%.... NOT_FOUND The protocol does not explicitly state the text.
eligibility_criteria.identifier	ALWAYS	ICH M11 §5.1	Eligibility Criteria Eligibility section criterion labels numbered/lettered list markers	Number Criterion I E 1 +6
Definition: REPEATING FIELD: return one value per eligibility criterion. The criterion number or label as listed in the protocol (e.g. 'I-1', 'E-3'). Format: `String (array — one per parent entity)` Capture Guidance: Extract the numbering scheme used (e.g. 'Inclusion 1', 'I1', '1.'). Extraction Boundary: Extract only the value for identifier as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the identifier: Example identifier. FOUND An abbreviated or edge-case statement still identifies the identifier: Abbrev identifier. NOT_FOUND The protocol does not explicitly state the identifier.
eligibility_criteria.structured	CONDITIONAL	CDISC Protocol Representation Model	Same sentence as criterion text clinical terms measurable parameters	age BMI weight height eGFR +11
Definition: REPEATING FIELD: return one value per eligibility criterion. Whether the criterion has been decomposed into structured components (identifier, operator, value, units). Format: `Boolean (array — one per parent entity)` Capture Guidance: true if the criterion is decomposed into machine-readable parts. Extraction Boundary: Extract only the value for structured as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the structured: True. FOUND An abbreviated or edge-case statement still identifies the structured: False. NOT_FOUND This protocol section indicates the structured does not apply for this study design. Allowed Values: True False Value Aliases: `True`: Yes, Y, True, 1 `False`: No, N, False, 0
eligibility_criteria.operator	CONDITIONAL	CDISC Protocol Representation Model	Eligibility Criteria Adjacent to value in criterion text comparison symbols comparison phrases	≥ = > between ≤ +8
Definition: REPEATING FIELD: return one value per eligibility criterion. Comparison operator for the quantitative threshold in this criterion. Extract per criterion. If a criterion has no quantitative threshold, set to null for that criterion. Format: `Enum string per criterion: GTE, LTE, GT, LT, EQ, BETWEEN, NOT_EQUAL, or null (array — one per parent entity)` Capture Guidance: Map protocol language to operators: ">=" or "at least" -> GTE. "<=" or "no more than" -> LTE. "<" -> LT. ">" -> GT. "X to Y" or "ranging from X to Y" -> BETWEEN. Extract per criterion alongside eligibility_criteria.text. Extraction Boundary: Extract only the value for operator as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the operator: Example operator. FOUND An abbreviated or edge-case statement still identifies the operator: Abbrev operator. NOT_FOUND This protocol section indicates the operator does not apply for this study design.
eligibility_criteria.value	CONDITIONAL	CDISC Protocol Representation Model	Eligibility Criteria Same sentence as criterion text numeric values categorical states	≥ ≤ > < = +10
Definition: REPEATING FIELD: return one value per eligibility criterion. The threshold value(s) for the quantitative component of this criterion. Extract per criterion. If a criterion has no quantitative threshold, set to null. For BETWEEN operators, provide both bounds as a list. Format: `String or number (array — one per parent entity)` Capture Guidance: Extract numeric values only. For ranges, use a two-element list [low, high]. Example: "35-70 years" -> [35, 70]. ">= 100 mg/dL" -> 100. Extraction Boundary: Extract only the value for value as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the value: Example value. FOUND An abbreviated or edge-case statement still identifies the value: Abbrev value. NOT_FOUND This protocol section indicates the value does not apply for this study design.
eligibility_criteria.units	CONDITIONAL	CDISC Protocol Representation Model	Eligibility Criteria Adjacent to numeric value in criterion text	years cells/μL mg/dL kg/m2 kg +10
Definition: REPEATING FIELD: return one value per eligibility criterion. Unit of measurement for the quantitative threshold in this criterion. Extract per criterion. Format: `String (e.g. 'years', 'kg/m2') (array — one per parent entity)` Capture Guidance: Common units: years, kg/m2, mg/dL, %, mmHg, ml/min, g/dl, ng/dl, mm. Use the unit as written in the protocol. Normalize only obvious abbreviations. Extraction Boundary: Extract only the value for units as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the units: Example units. FOUND An abbreviated or edge-case statement still identifies the units: Abbrev units. NOT_FOUND This protocol section indicates the units does not apply for this study design.
eligibility_criteria.timeframe	CONDITIONAL	ICH M11 §5.1; SPIRIT 2013 Item 10	Eligibility Criteria Same sentence as criterion text temporal phrases time-related prepositions	Days Within Before At screening Prior to +15
Definition: REPEATING FIELD: return one value per eligibility criterion. Time window or lookback period associated with this criterion. Extract per criterion. Examples: "within 3 months of study entry", "in the past six months", "within 14 days". Format: `Free text (array — one per parent entity)` Capture Guidance: Extract the temporal qualifier for each criterion. Example: "Use of glucocorticoids in the past six months" -> "6 months prior". Extraction Boundary: Extract only the value for timeframe as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the timeframe: Example timeframe. FOUND An abbreviated or edge-case statement still identifies the timeframe: Abbrev timeframe. NOT_FOUND This protocol section indicates the timeframe does not apply for this study design.
eligibility_criteria.negationFlag	ALWAYS	CDISC Protocol Representation Model	Eligibility Criteria Beginning of criterion text negative phrases exclusionary language	Must not Absence of Not Without No +11
Definition: REPEATING FIELD: return one value per eligibility criterion. Whether the criterion is stated in the negative (must NOT have). Format: `Boolean (array — one per parent entity)` Capture Guidance: true for exclusion-style phrasing. Common in exclusion criteria. Extraction Boundary: Extract only the value for negationFlag as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the negationFlag: True. FOUND An abbreviated or edge-case statement still identifies the negationFlag: False. NOT_FOUND The protocol does not explicitly state the negationFlag. Allowed Values: True False Value Aliases: `True`: Yes, Y, True, 1 `False`: No, N, False, 0
eligibility_criteria.assumption	OPTIONAL	Internal	N/A — generated by Design Agent not extracted from protocol	assumed interpreted split combined inferred +1
Definition: REPEATING FIELD: return one value per eligibility criterion. Assumptions made during extraction of this criterion. Format: `Free text (array — one per parent entity)` Capture Guidance: Document assumptions when criterion language is ambiguous. Extraction Boundary: Extract only the value for assumption as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the assumption: Example assumption. FOUND An abbreviated or edge-case statement still identifies the assumption: Abbrev assumption. NOT_FOUND This protocol section indicates the assumption does not apply for this study design.
eligibility_criteria.notes	OPTIONAL	Internal	Eligibility Criteria Footnotes parentheticals clarifications in protocol	note see refer to footnote * +3
Definition: REPEATING FIELD: return one value per eligibility criterion. Additional notes about this criterion. Format: `Free text (array — one per parent entity)` Capture Guidance: Capture footnotes or clarifications. Extraction Boundary: Extract only the value for notes as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the notes: Example notes. FOUND An abbreviated or edge-case statement still identifies the notes: Abbrev notes. NOT_FOUND This protocol section indicates the notes does not apply for this study design.
eligibility_criteria.pageNumber	ALWAYS	Internal — auto-populated	Page headers page footers PDF page numbers	page p. pg. of /
Definition: Page number where eligibility criterion was found. Format: `Integer` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageNumber: Example pageNumber. FOUND An abbreviated or edge-case statement still identifies the pageNumber: Abbrev pageNumber. NOT_FOUND The protocol does not explicitly state the pageNumber.

Encounters And Visits

17 fields

▼

Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
encounters_and_visits.encId	SYSTEM	CDISC SDTM SV; ICH M11 §5	Encounters and Visits Schedule of Activities SoE visit ID column Visit Schedule Study Design	Visit ID Encounter ID Visit Encounter V# +3
Definition: Unique identifier for this encounter/visit record. Format: `String` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for encId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the encId.
encounters_and_visits.encounterName	ALWAYS	ICH M11 §5; SPIRIT 2013 Item 13	Encounters and Visits Schedule of Activities SoE column header Visit Schedule Study Design	Visit name Encounter Visit Baseline Follow-up +1
Definition: REPEATING FIELD: return one value per study visit/encounter. The formal name of the study encounter. Format: `Free text string (array — one per parent entity)` Capture Guidance: Use the exact visit name from the protocol or SoA. Extraction Boundary: Extract only the value for encounterName as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the encounterName: Example encounterName. FOUND An abbreviated or edge-case statement still identifies the encounterName: Abbrev encounterName. NOT_FOUND The protocol does not explicitly state the encounterName.
encounters_and_visits.visitLabel	ALWAYS	ICH M11 §5; SPIRIT 2013 Item 13	Encounters and Visits Schedule of Activities SoE header (combined) Visit Schedule CRF codes	Visit label Wk V1 Day V# +5
Definition: Short display label for the visit (e.g. 'V1', 'Wk4', 'EOT'). Format: `Free text string` Capture Guidance: Use the abbreviated label from the SoA column header. Extraction Boundary: Extract only the value for visitLabel as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the visitLabel: Example visitLabel. FOUND An abbreviated or edge-case statement still identifies the visitLabel: Abbrev visitLabel. NOT_FOUND The protocol does not explicitly state the visitLabel.
encounters_and_visits.purpose	ALWAYS	ICH M11 §5; SPIRIT 2013 Item 13	Encounters and Visits Schedule of Activities Visit Schedule purpose Narrative SoE footnotes	Treatment Follow-up Screening Purpose Safety +5
Definition: REPEATING FIELD: return one value per study visit/encounter. The primary purpose of the encounter. Format: `Free text (array — one per parent entity)` Capture Guidance: Describe the main purpose (e.g. 'Eligibility assessment', 'Efficacy evaluation'). Extraction Boundary: Extract only the value for purpose as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the purpose: Example purpose. FOUND An abbreviated or edge-case statement still identifies the purpose: Abbrev purpose. NOT_FOUND The protocol does not explicitly state the purpose.
encounters_and_visits.epochReference	CONDITIONAL	CDISC SDTM SE; ICH M11 §4	Encounters and Visits Schedule of Activities SoE epoch header Visit grouping Study Design	Treatment Epoch Follow-up Screening Period +1
Definition: Reference to the study epoch this visit belongs to. Format: `Free text or UUID` Capture Guidance: Link the visit to its parent epoch. Extraction Boundary: Extract only the value for epochReference as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the epochReference: STUDY-DESIGN-001. FOUND An abbreviated or edge-case statement still identifies the epochReference: PROTO-2026-02. NOT_FOUND This protocol section indicates the epochReference does not apply for this study design.
encounters_and_visits.studyDay	ALWAYS	ICH M11 §5; SPIRIT 2013 Item 13	Encounters and Visits Schedule of Activities SoE "Study Day" row Visit Schedule Timeline	Day Study day D1 D28 Study Day +2
Definition: The planned study day for this visit relative to Day 1. Format: `Integer (negative for pre-Day 1)` Capture Guidance: Day 1 is typically randomization/first dose. Screening days are negative. Extraction Boundary: Extract only the value for studyDay as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the studyDay: Example studyDay. FOUND An abbreviated or edge-case statement still identifies the studyDay: Abbrev studyDay. NOT_FOUND The protocol does not explicitly state the studyDay.
encounters_and_visits.windowMinus	ALWAYS	ICH M11 §5; SPIRIT 2013 Item 13	Encounters and Visits Schedule of Activities SoE window row Visit Schedule Narrative	Window Before Minus ± days before +1
Definition: REPEATING FIELD: return one value per study visit/encounter. Lower bound of the visit window (days before scheduled day). Format: `Integer (days) (array — one per parent entity)` Capture Guidance: Extract from '±3 days' → windowMinus=3. Extraction Boundary: Extract only the value for windowMinus as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the windowMinus: Example windowMinus. FOUND An abbreviated or edge-case statement still identifies the windowMinus: Abbrev windowMinus. NOT_FOUND The protocol does not explicitly state the windowMinus.
encounters_and_visits.windowPlus	ALWAYS	ICH M11 §5; SPIRIT 2013 Item 13	Encounters and Visits Schedule of Activities SoE window row Visit Schedule Narrative	Window Plus After ± days after +1
Definition: REPEATING FIELD: return one value per study visit/encounter. Upper bound of the visit window (days after scheduled day). Format: `Integer (days) (array — one per parent entity)` Capture Guidance: Extract from '±3 days' → windowPlus=3. Extraction Boundary: Extract only the value for windowPlus as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the windowPlus: Example windowPlus. FOUND An abbreviated or edge-case statement still identifies the windowPlus: Abbrev windowPlus. NOT_FOUND The protocol does not explicitly state the windowPlus.
encounters_and_visits.duration	CONDITIONAL	ICH M11 §5	Encounters and Visits SoE duration row Visit Schedule Narrative	Duration Hours Visit length hours minutes +1
Definition: Expected duration of the visit. Format: `String with unit (e.g. '4 hours')` Capture Guidance: Extract if stated; particularly relevant for PK-intensive visits. Extraction Boundary: Extract only the value for duration as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the duration: Example duration. FOUND An abbreviated or edge-case statement still identifies the duration: Abbrev duration. NOT_FOUND This protocol section indicates the duration does not apply for this study design.
encounters_and_visits.mode	CONDITIONAL	ICH M11 §5; ICH E6(R2) Amendment 2	Encounters and Visits Schedule of Activities SoE mode indicator Visit notes Narrative	In-person Phone Telehealth Remote On-site
Definition: Type of contact for this visit (in-person, phone, electronic). Format: `Enum string` Capture Guidance: IN_PERSON for clinic visits. PHONE for telephone-only. Extraction Boundary: Extract only the value for mode as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the mode: IN_PERSON. FOUND An abbreviated or edge-case statement still identifies the mode: PHONE. NOT_FOUND This protocol section indicates the mode does not apply for this study design. Allowed Values: IN_PERSON PHONE ELECTRONIC HOME_VISIT HYBRID Value Aliases: `IN_PERSON`: In-person, In person, On-site, Clinic visit, Office visit `PHONE`: Phone, Telephone, Phone call, Teleconsultation `ELECTRONIC`: Electronic, ePRO, eDiary, Virtual, Telemedicine `HOME_VISIT`: Home visit, Home, Home nursing, Home health `HYBRID`: Hybrid, Mixed, In-person or remote
encounters_and_visits.location	CONDITIONAL	ICH M11 §5	Encounters and Visits SoE location indicator Visit Schedule Narrative	Home Hospital Clinic Location Site +3
Definition: REPEATING FIELD: return one value per study visit/encounter. Where the encounter takes place. Format: `Free text (array — one per parent entity)` Capture Guidance: E.g. 'Study site', 'Home', 'Hospital inpatient unit'. Extraction Boundary: Extract only the value for location as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the location: Example location. FOUND An abbreviated or edge-case statement still identifies the location: Abbrev location. NOT_FOUND This protocol section indicates the location does not apply for this study design.
encounters_and_visits.required	ALWAYS	ICH M11 §5; SPIRIT 2013 Item 13	Encounters and Visits Schedule of Activities SoE required indicator Visit notes Narrative	Optional Conditional Required Mandatory PRN
Definition: Whether this visit is mandatory per protocol. Format: `Boolean` Capture Guidance: true for scheduled visits. false for unscheduled or conditional. Extraction Boundary: Extract only the value for required as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the required: True. FOUND An abbreviated or edge-case statement still identifies the required: False. NOT_FOUND The protocol does not explicitly state the required. Allowed Values: True False Value Aliases: `True`: Yes, Y, True, 1 `False`: No, N, False, 0
encounters_and_visits.overnightStay	CONDITIONAL	ICH M11 §5	Encounters and Visits Study Procedures SoE inpatient indicator Visit Schedule Narrative	Admission Confinement Overnight Inpatient Stay +1
Definition: REPEATING FIELD: return one value per study visit/encounter. Whether an overnight stay is required for this visit. Format: `Boolean (array — one per parent entity)` Capture Guidance: true for visits requiring overnight hospitalisation. Extraction Boundary: Extract only the value for overnightStay as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the overnightStay: True. FOUND An abbreviated or edge-case statement still identifies the overnightStay: False. NOT_FOUND This protocol section indicates the overnightStay does not apply for this study design. Allowed Values: True False Value Aliases: `True`: Yes, Y, True, 1 `False`: No, N, False, 0
encounters_and_visits.labsRequired	ALWAYS	ICH M11 §5; SPIRIT 2013 Item 13	Encounters and Visits Schedule of Activities SoE labs rows (X marks) Visit activities Narrative	Blood work Blood draw Laboratory Labs Safety labs +2
Definition: REPEATING FIELD: return one value per study visit/encounter. Whether laboratory assessments are required at this visit. Format: `Boolean (array — one per parent entity)` Capture Guidance: true if the SoA marks lab activities at this visit. Extraction Boundary: Extract only the value for labsRequired as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the labsRequired: True. FOUND An abbreviated or edge-case statement still identifies the labsRequired: False. NOT_FOUND The protocol does not explicitly state the labsRequired. Allowed Values: True False Value Aliases: `True`: Yes, Y, True, 1 `False`: No, N, False, 0
encounters_and_visits.activitiesPerformed	ALWAYS	ICH M11 §5; SPIRIT 2013 Item 13	Schedule of Activities SoE rows with X marks Visit description Narrative	Assessments Procedures Activities X
Definition: List or summary of activities/assessments performed at this visit. Format: `Free text or list` Capture Guidance: Summarise key activities from the SoA row for this visit. Extraction Boundary: Extract only the value for activitiesPerformed as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the activitiesPerformed: ['Example item 1', 'Example item 2']. FOUND An abbreviated or edge-case statement still identifies the activitiesPerformed:... NOT_FOUND The protocol does not explicitly state the activitiesPerformed.
encounters_and_visits.pageNumber	ALWAYS	Internal — auto-populated	Captured during extraction from SoE	p. page pp.
Definition: Page number where visit information was found. Format: `Integer` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageNumber: Example pageNumber. FOUND An abbreviated or edge-case statement still identifies the pageNumber: Abbrev pageNumber. NOT_FOUND The protocol does not explicitly state the pageNumber.
encounters_and_visits.pageSection	ALWAYS	Internal — auto-populated	Captured during extraction typically "Schedule of Events"	Schedule of Events SoE Visit Schedule
Definition: Section heading where visit information was found. Format: `Free text` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageSection as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageSection: Example pageSection. FOUND An abbreviated or edge-case statement still identifies the pageSection: Abbrev pageSection. NOT_FOUND The protocol does not explicitly state the pageSection.

Epochs

10 fields

▼

Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
epochs.epochId	SYSTEM	CDISC SDTM SE; ICH M11 §4	Study Design Study Epochs table/diagram SoA headers Study Schema	Epoch ID Epoch Period Phase Study Period +1
Definition: Unique identifier for this epoch record. Format: `String` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for epochId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the epochId.
epochs.epochName	ALWAYS	CDISC SDTM SE; ICH M11 §4; SPIRIT 2013 Item 13	Schedule of Activities Study Design Synopsis Study Epochs table/diagram Study Design narrative SoA headers	Screening period Treatment period Follow-up period Epoch Period +6
Definition: The name of the study epoch. Format: `Free text string` Capture Guidance: Common epochs: Screening, Run-in, Treatment, Washout, Follow-up, Extension. Extraction Boundary: Extract only the value for epochName as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the epochName: Example epochName. FOUND An abbreviated or edge-case statement still identifies the epochName: Abbrev epochName. NOT_FOUND The protocol does not explicitly state the epochName.
epochs.epochType	CONDITIONAL	CDISC SDTM SE TAETORD; ICH M11 §4	Schedule of Activities Study Design Epochs/Study Periods section type column Epoch header/label Legend	Treatment Extension Washout Follow-up Screening +7
Definition: REPEATING FIELD: return one value per study epoch. Classification of the epoch by its role in the study timeline. Format: `Enum string (array — one per parent entity)` Capture Guidance: Infer epoch type from its name and purpose. "screening" or "eligibility assessment" -> SCREENING. Drug administration period -> TREATMENT. Period between crossover treatments -> WASHOUT. Period after last dose -> FOLLOW_UP. Run-in or lead-in -> RUN_IN. Extraction Boundary: Extract only the value for epochType as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the epochType: SCREENING. FOUND An abbreviated or edge-case statement still identifies the epochType: RUN_IN. NOT_FOUND This protocol section indicates the epochType does not apply for this study design. Allowed Values: SCREENING RUN_IN TREATMENT WASHOUT FOLLOW_UP EXTENSION OTHER Value Aliases: `SCREENING`: Screening, screening, SCREEN, Screen, Eligibility `RUN_IN`: Run-in, Run in, run-in, RUN-IN, Lead-in, lead-in, Stabilization, Washout/Run-in `TREATMENT`: Treatment, treatment, TREATMENT, Active treatment, Intervention, Dosing, On-treatment `WASHOUT`: Washout, washout, WASHOUT, Wash-out, Rest period `FOLLOW_UP`: Follow-up, Follow up, follow-up, FOLLOW-UP, FOLLOW_UP, Post-treatment, Safety follow-up, Survival follow-up `EXTENSION`: Extension, extension, EXTENSION, Open-label extension, OLE, Long-term extension, LTE
epochs.purpose	ALWAYS	CDISC SDTM SE; ICH M11 §4	Schedule of Activities Study Design Purpose text in epoch description Study Design narrative Epoch table	Objective of period Purpose Objective Used for To assess +2
Definition: REPEATING FIELD: return one value per study epoch. The purpose of this epoch. Format: `Free text (array — one per parent entity)` Capture Guidance: Describe the purpose (e.g. 'Assess eligibility', 'Evaluate treatment effect'). Extraction Boundary: Extract only the value for purpose as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the purpose: Example purpose. FOUND An abbreviated or edge-case statement still identifies the purpose: Abbrev purpose. NOT_FOUND The protocol does not explicitly state the purpose.
epochs.duration	ALWAYS	ICH M11 §4; SPIRIT 2013 Item 13	Schedule of Activities Study Design Synopsis Epoch duration column Study Design narrative SoA schedule	Duration Days Months Weeks Up to +1
Definition: Planned duration of the epoch. Format: `String with unit (e.g. '12 weeks')` Capture Guidance: Extract the planned duration from study design or SoA. Extraction Boundary: Extract only the value for duration as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the duration: Example duration. FOUND An abbreviated or edge-case statement still identifies the duration: Abbrev duration. NOT_FOUND The protocol does not explicitly state the duration.
epochs.sequenceInStudy	ALWAYS	CDISC SDTM SE TAETORD	Schedule of Activities Study Design Epoch sequence column Study flow diagram Study Design narrative	Sequence Order 1,2,3 First Second +1
Definition: The chronological order of this epoch in the study. Format: `Integer` Capture Guidance: Assign sequentially: Screening=1, Run-in=2, Treatment=3, etc. Extraction Boundary: Extract only the value for sequenceInStudy as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the sequenceInStudy: Example sequenceInStudy. FOUND An abbreviated or edge-case statement still identifies the sequenceInStudy: Abbrev... NOT_FOUND The protocol does not explicitly state the sequenceInStudy.
epochs.transitionRule	CONDITIONAL	CDISC SDTM TE; ICH M11 §4	Study Design Transition statement between epochs Study Design narrative Study Schema	Move to Proceed to Completion criteria Transition Enter +2
Definition: REPEATING FIELD: return one value per study epoch. Rule governing transition from this epoch to the next. Format: `Free text (array — one per parent entity)` Capture Guidance: Describe conditions for ending this epoch and starting the next. Extraction Boundary: Extract only the value for transitionRule as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the transitionRule: Example transitionRule. FOUND An abbreviated or edge-case statement still identifies the transitionRule: Abbrev... NOT_FOUND This protocol section indicates the transitionRule does not apply for this study design.
epochs.notes	OPTIONAL	Internal	Study Design Footnotes/notes under epoch table Study Design notes	Note Footnote Remark Comment
Definition: REPEATING FIELD: return one value per study epoch. Additional notes about this epoch. Format: `Free text (array — one per parent entity)` Capture Guidance: Capture epoch-specific caveats or footnotes. Extraction Boundary: Extract only the value for notes as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the notes: Example notes. FOUND An abbreviated or edge-case statement still identifies the notes: Abbrev notes. NOT_FOUND This protocol section indicates the notes does not apply for this study design.
epochs.pageNumber	ALWAYS	Internal — auto-populated	Captured during extraction	p. page pp.
Definition: Page number where epoch information was found. Format: `Integer` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageNumber: Example pageNumber. FOUND An abbreviated or edge-case statement still identifies the pageNumber: Abbrev pageNumber. NOT_FOUND The protocol does not explicitly state the pageNumber.
epochs.pageSection	ALWAYS	Internal — auto-populated	Captured during extraction	Section Table Study Epochs Study Design
Definition: Section heading where epoch information was found. Format: `Free text` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageSection as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageSection: Example pageSection. FOUND An abbreviated or edge-case statement still identifies the pageSection: Abbrev pageSection. NOT_FOUND The protocol does not explicitly state the pageSection.

Interventions

17 fields

▼

Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
interventions.interventionId	SYSTEM	CDISC Protocol Representation Model; ICH M11 §4.3	Interventions N/A (System) or Interventions table header	Intervention ID Intervention Investigational product Study treatment
Definition: Unique identifier for this intervention record. Format: `String` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for interventionId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the interventionId.
interventions.name	ALWAYS	ICH M11 §4.3; SPIRIT 2013 Item 11a; CDISC SDTM TS TSPARMCD=TRT	Interventions Study Design Synopsis Intervention section Investigational Product Study Drug	IMP Investigational product Treatment name Study drug Drug name +3
Definition: The name of the study intervention or treatment. Format: `Free text string` Capture Guidance: Use the generic (INN) name; include brand name in parentheses if stated. Extraction Boundary: Extract only the value for name as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the name: Example name. FOUND An abbreviated or edge-case statement still identifies the name: Abbrev name. NOT_FOUND The protocol does not explicitly state the name.
interventions.label	OPTIONAL	ICH M11 §4.3	Study Design Interventions Arms Intervention table Arms abbreviations	Label Code Treatment code
Definition: Short label or code for the intervention (e.g. 'Drug A', 'Placebo'). Format: `Free text string` Capture Guidance: Short identifier used in study design descriptions and SoA. Extraction Boundary: Extract only the value for label as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the label: Example label. FOUND An abbreviated or edge-case statement still identifies the label: Abbrev label. NOT_FOUND This protocol section indicates the label does not apply for this study design.
interventions.type	OPTIONAL	ICH M11 §4.3; SPIRIT 2013 Item 11a; CDISC SDTM TS TSPARMCD=INTTYPE	Interventions Study Design Intervention summary Regulatory section	Biologic Drug Sham Placebo Device +2
Definition: Category of the intervention. Format: `Enum string` Capture Guidance: DRUG for small-molecule pharmaceutical agents (capsules, tablets, oral solution). BIOLOGICAL for antibodies, vaccines, gene/cell therapies. PLACEBO for inert comparator matched to active. Infer from the formulation and IND/BLA filing type. Extraction Boundary: Extract only the value for type as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the type: DRUG. FOUND An abbreviated or edge-case statement still identifies the type: BIOLOGICAL. NOT_FOUND This protocol section indicates the type does not apply for this study design. Allowed Values: DRUG BIOLOGICAL DEVICE PLACEBO SHAM DIETARY_SUPPLEMENT PROCEDURE RADIATION BEHAVIORAL OTHER Value Aliases: `DRUG`: Drug, drug, Small molecule, Pharmaceutical `BIOLOGICAL`: Biological, Biologic, biological, biologic, Biosimilar `DEVICE`: Device, device, Medical device `PLACEBO`: Placebo, placebo, Matching placebo, Dummy `SHAM`: Sham, sham, Sham procedure
interventions.description	OPTIONAL	ICH M11 §4.3; SPIRIT 2013 Item 11a	Interventions Study Design Intervention narrative Product description	Presentation Appearance Description Formulation description +1
Definition: Full description of the intervention including formulation and appearance. Format: `Free text` Capture Guidance: Include formulation type, physical appearance, and packaging. Extraction Boundary: Extract only the value for description as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the description: Example description. FOUND An abbreviated or edge-case statement still identifies the description: Abbrev description. NOT_FOUND This protocol section indicates the description does not apply for this study design.
interventions.dose	OPTIONAL	ICH M11 §4.3; SPIRIT 2013 Item 11a; CDISC SDTM TS TSPARMCD=DOSE	Interventions Study Design Synopsis Dosing section Treatment administration	mg/kg Dosage Dose mg/m2 mg +2
Definition: The dose amount for the intervention. Format: `String (e.g. '100', '5')` Capture Guidance: Extract the dose as stated in the protocol text. For dose escalation, extract the specific dose levels ONLY if they are explicitly stated in the protocol text (not from figures or external references). If the protocol describes a dose escalation period but defers the specific dose steps to a figure, study manual, or approved product label, extract the maintenance dose and state 'dose escalation over [N] weeks; specific steps refer to [source]'. Do NOT infer dose escalation steps from the approved product label (e.g., Prescribing Information) unless the protocol explicitly incorporates them by reference. Prefix reasoning_summary with 'FIGURE_REFERENCE:' when dose information is available only in a figure. Extraction Boundary: Extract only the dose amount and strength. Do not include frequency, route, formulation, or treatment duration. Examples: FOUND The protocol explicitly states the dose: Example dose. FOUND An abbreviated or edge-case statement still identifies the dose: Abbrev dose. NOT_FOUND This protocol section indicates the dose does not apply for this study design.
interventions.doseUnits	CONDITIONAL	ICH M11 §4.3; CDISC SDTM TS TSPARMCD=DOSEU	Interventions Study Design Same sentence as dose	mg/kg Units IU mg/m2 mcg +3
Definition: Units for the dose amount. Format: `String (e.g. 'mg', 'mg/kg')` Capture Guidance: Extract the dose unit separately from the dose amount. Extraction Boundary: Extract only the value for doseUnits as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the doseUnits: Example doseUnits. FOUND An abbreviated or edge-case statement still identifies the doseUnits: Abbrev doseUnits. NOT_FOUND This protocol section indicates the doseUnits does not apply for this study design.
interventions.frequency	OPTIONAL	ICH M11 §4.3; SPIRIT 2013 Item 11a; CDISC SDTM TS TSPARMCD=DOSFRQ	Interventions Study Design Dose schedule Treatment administration	Frequency QD BID Q2W Weekly +4
Definition: How often the intervention is administered. Format: `Free text (e.g. 'QD', 'Every 3 weeks')` Capture Guidance: Use standard abbreviations where available (QD, BID, QW, Q2W, Q3W). Extraction Boundary: Extract only how often the intervention is administered, such as once daily or every 2 weeks. Do not capture dose amount or overall treatment duration. Examples: FOUND The protocol explicitly states the frequency: Example frequency. FOUND An abbreviated or edge-case statement still identifies the frequency: Abbrev frequency. NOT_FOUND This protocol section indicates the frequency does not apply for this study design.
interventions.route	OPTIONAL	ICH M11 §4.3; SPIRIT 2013 Item 11a; CDISC SDTM TS TSPARMCD=ROUTE	Interventions Study Design Dosing/Administration section	Topical Oral SC Intramuscular IM +6
Definition: Route of administration for the intervention. Format: `Enum string` Capture Guidance: ORAL if described as tablets, capsules, oral solution, or "by mouth." INTRAVENOUS if described as IV infusion/injection. SUBCUTANEOUS if described as SC injection. Infer from formulation and administration descriptions. Extraction Boundary: Extract only the value for route as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the route: ORAL. FOUND An abbreviated or edge-case statement still identifies the route: INTRAVENOUS. NOT_FOUND This protocol section indicates the route does not apply for this study design. Allowed Values: ORAL INTRAVENOUS SUBCUTANEOUS INTRAMUSCULAR TOPICAL INHALED INTRANASAL INTRATHECAL OPHTHALMIC TRANSDERMAL OTHER Value Aliases: `ORAL`: Oral, oral, PO, po, By mouth, Orally `INTRAVENOUS`: Intravenous, intravenous, IV, iv, I.V., IV infusion, IV push, IV bolus, Intravenous infusion `SUBCUTANEOUS`: Subcutaneous, subcutaneous, SC, sc, S.C., SQ, SubQ, Subcutaneous injection `INTRAMUSCULAR`: Intramuscular, intramuscular, IM, im, I.M., Intramuscular injection `TOPICAL`: Topical, topical, Cutaneous, Dermal, Transdermal patch `INHALED`: Inhaled, inhaled, Inhalation, inhalation, Nebulised, Nebulized, Metered dose, DPI `INTRANASAL`: Intranasal, intranasal, IN, Nasal, nasal `INTRATHECAL`: Intrathecal, intrathecal, IT, Spinal `OPHTHALMIC`: Ophthalmic, ophthalmic, Intravitreal, intravitreal, IVT, Eye drop, Ocular `TRANSDERMAL`: Transdermal, transdermal, Patch, TDS
interventions.formulation	OPTIONAL	ICH M11 §4.3; CDISC SDTM TS TSPARMCD=DOSFORM	Interventions Pharmacy/IMP section Product description	Solution Formulation Capsule Injection Suspension +5
Definition: The pharmaceutical dosage form of the intervention. Format: `Free text (e.g. 'Film-coated tablet')` Capture Guidance: Use the exact dosage form from the protocol. Extraction Boundary: Extract only the value for formulation as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the formulation: Example formulation. FOUND An abbreviated or edge-case statement still identifies the formulation: Abbrev formulation. NOT_FOUND This protocol section indicates the formulation does not apply for this study design.
interventions.duration	OPTIONAL	ICH M11 §4.3; SPIRIT 2013 Item 11a; CDISC SDTM TS TSPARMCD=TRTDUR	Interventions Study Design Treatment administration Duration section	Treatment duration Cycles Duration of treatment duration weeks +2
Definition: Planned duration of treatment with this intervention. Format: `String with unit (e.g. '12 weeks', 'until progression')` Capture Guidance: May be fixed, cycle-based, or event-driven. Extraction Boundary: Extract only the overall treatment duration or planned treatment period. Do not capture dose amount or administration frequency. Examples: FOUND The protocol explicitly states the duration: Example duration. FOUND An abbreviated or edge-case statement still identifies the duration: Abbrev duration. NOT_FOUND This protocol section indicates the duration does not apply for this study design.
interventions.crossoverPeriod	CONDITIONAL	ICH M11 §4.2; ICH E9 §2.3.4	Study Design Interventions Crossover section (if present)	Period Crossover period Treatment period period crossover
Definition: For crossover designs, which treatment period this intervention belongs to. Format: `String or integer` Capture Guidance: Only relevant for crossover designs. Extraction Boundary: Extract only the value for crossoverPeriod as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the crossoverPeriod: Example crossoverPeriod. FOUND An abbreviated or edge-case statement still identifies the crossoverPeriod: Abbrev... NOT_FOUND This protocol section indicates the crossoverPeriod does not apply for this study design.
interventions.manufacturer	OPTIONAL	ICH M11 §4.3	Interventions Sponsor/Manufacturer Drug Supply section	Supplier Supplied by Manufacturer manufacturer supplied by
Definition: The manufacturer or supplier of the intervention. Format: `Free text string` Capture Guidance: Extract if stated in the drug supplies section. Extraction Boundary: Extract only the value for manufacturer as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the manufacturer: Example manufacturer. FOUND An abbreviated or edge-case statement still identifies the manufacturer: Abbrev manufacturer. NOT_FOUND This protocol section indicates the manufacturer does not apply for this study design.
interventions.indNumber	OPTIONAL	ICH M11 §4.3; FDA regulations 21 CFR 312	Title Page Interventions Regulatory/IND section Title page	IND IND number Investigational New Drug
Definition: Investigational New Drug (IND) application number for this intervention. Format: `String` Capture Guidance: US-specific regulatory identifier for the investigational product. Extraction Boundary: Extract only the value for indNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the indNumber: Example indNumber. FOUND An abbreviated or edge-case statement still identifies the indNumber: Abbrev indNumber. NOT_FOUND This protocol section indicates the indNumber does not apply for this study design.
interventions.assumptionNotes	OPTIONAL	Internal	N/A (Documentation field)	—
Definition: Assumptions made during extraction of intervention data. Format: `Free text` Capture Guidance: Document assumptions when protocol is ambiguous about this intervention. Extraction Boundary: Extract only the value for assumptionNotes as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the assumptionNotes: Example assumptionNotes. FOUND An abbreviated or edge-case statement still identifies the assumptionNotes: Abbrev... NOT_FOUND This protocol section indicates the assumptionNotes does not apply for this study design.
interventions.pageNumber	ALWAYS	Internal — auto-populated	Same location as evidence	p.
Definition: Page number where intervention information was found. Format: `Integer` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageNumber: Example pageNumber. FOUND An abbreviated or edge-case statement still identifies the pageNumber: Abbrev pageNumber. NOT_FOUND The protocol does not explicitly state the pageNumber.
interventions.pageSection	ALWAYS	Internal — auto-populated	Section headers in protocol	Section Study Interventions Dosing
Definition: Section heading where intervention information was found. Format: `Free text` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageSection as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageSection: Example pageSection. FOUND An abbreviated or edge-case statement still identifies the pageSection: Abbrev pageSection. NOT_FOUND The protocol does not explicitly state the pageSection.

Objectives And Endpoints

17 fields

▼

Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
objectives_and_endpoints.oeId	SYSTEM	ICH M11 §3	Objectives and Endpoints Objective/Endpoint tables else system fallback	ID OBJ EP Endpoint Objective
Definition: Unique identifier for this objective/endpoint record. Format: `String` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for oeId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the oeId.
objectives_and_endpoints.name	ALWAYS	ICH M11 §3.1; SPIRIT 2013 Item 7	Objectives and Endpoints Synopsis Objectives section headings Summary tables	Outcome Endpoint Objective to evaluate to assess +1
Definition: REPEATING FIELD: return one value per objective or endpoint. The short name or title of the objective or endpoint. Format: `Free text string (array — one per parent entity)` Capture Guidance: Use a concise name for the objective/endpoint. Extraction Boundary: Extract only the value for name as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the name: Example name. FOUND An abbreviated or edge-case statement still identifies the name: Abbrev name. NOT_FOUND The protocol does not explicitly state the name.
objectives_and_endpoints.recordType	ALWAYS	ICH M11 §3	Objectives and Endpoints Objectives section Endpoints section Synopsis	Endpoint Objective objective endpoint primary +2
Definition: REPEATING FIELD: return one value per objective or endpoint. Whether this record represents an objective or an endpoint. Format: `Enum string (array — one per parent entity)` Capture Guidance: OBJECTIVE for study objectives. ENDPOINT for outcome measures. Extraction Boundary: Extract only the value for recordType as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the recordType: OBJECTIVE. FOUND An abbreviated or edge-case statement still identifies the recordType: ENDPOINT. NOT_FOUND The protocol does not explicitly state the recordType. Allowed Values: OBJECTIVE ENDPOINT Value Aliases: `OBJECTIVE`: Objective, objective, Aim, Goal `ENDPOINT`: Endpoint, endpoint, End point, Outcome, Outcome measure
objectives_and_endpoints.level	ALWAYS	ICH M11 §3.1; SPIRIT 2013 Item 7	Objectives and Endpoints Synopsis Bullets near Primary/Secondary/Exploratory	Exploratory Key secondary Secondary Tertiary Primary +4
Definition: REPEATING FIELD: return one value per objective or endpoint. The hierarchical level of the objective or endpoint. Format: `Enum string (array — one per parent entity)` Capture Guidance: Classify as PRIMARY, SECONDARY, KEY_SECONDARY, EXPLORATORY, or TERTIARY based on the section header in the protocol (e.g., "Primary Outcome", "Secondary Outcomes"). If the protocol's numbering contains errors (e.g., duplicate numbers in secondary outcomes list), note the numbering error in evidence but extract all unique endpoints regardless. Extraction Boundary: Extract only the value for level as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the level: PRIMARY. FOUND An abbreviated or edge-case statement still identifies the level: SECONDARY. NOT_FOUND The protocol does not explicitly state the level. Allowed Values: PRIMARY SECONDARY KEY_SECONDARY EXPLORATORY TERTIARY Value Aliases: `PRIMARY`: Primary, primary, PRIMARY, Main, Principal `SECONDARY`: Secondary, secondary, SECONDARY, Other `KEY_SECONDARY`: Key secondary, Key Secondary, key secondary, KEY_SECONDARY, Major secondary, Gated secondary, Multiplicity-controlled secondary `EXPLORATORY`: Exploratory, exploratory, EXPLORATORY, Tertiary, Hypothesis-generating, Post-hoc, Ad hoc
objectives_and_endpoints.description	ALWAYS	ICH M11 §3.2; SPIRIT 2013 Item 12; ICH E9(R1)	Objectives and Endpoints Statistical Considerations Synopsis Objective/endpoint text paragraphs	Outcome Endpoint Objective to evaluate… to assess… +1
Definition: REPEATING FIELD: return one value per objective or endpoint. The full text describing the objective or endpoint. For primary objectives, may span multiple sentences; include the complete objective statement including the study population context. Format: `Free text (array — one per parent entity)` Capture Guidance: Extract the complete definition including measurement, timing, and population. Extraction Boundary: Extract the full endpoint or objective description. Do not reduce it to only the measurement variable or the analysis method. Examples: FOUND The protocol explicitly states the description: Example description. FOUND An abbreviated or edge-case statement still identifies the description: Abbrev description. NOT_FOUND The protocol does not explicitly state the description.
objectives_and_endpoints.purpose	ALWAYS	ICH M11 §3.2; ICH E9(R1)	Objectives and Endpoints	Efficacy Biomarker PRO Safety PK +5
Definition: REPEATING FIELD: return one value per objective or endpoint. The scientific purpose of the objective (efficacy, safety, PK, etc.). Format: `Enum string (array — one per parent entity)` Capture Guidance: Classify each endpoint's purpose. Infer from the measurement type: biomarker/PD parameter -> PHARMACODYNAMIC. Clinical outcome -> EFFICACY. AE/SAE counts -> SAFETY. PK parameters -> PHARMACOKINETIC. If the primary endpoint is a pharmacodynamic biomarker (e.g., insulin sensitivity index) in a short-term pilot, classify as PHARMACODYNAMIC, not EFFICACY. Extraction Boundary: Extract only the value for purpose as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the purpose: EFFICACY. FOUND An abbreviated or edge-case statement still identifies the purpose: SAFETY. NOT_FOUND The protocol does not explicitly state the purpose. Allowed Values: EFFICACY SAFETY PHARMACOKINETIC PHARMACODYNAMIC BIOMARKER PATIENT_REPORTED_OUTCOME COMPOSITE OTHER Value Aliases: `EFFICACY`: Efficacy, efficacy, Effectiveness `SAFETY`: Safety, safety, Tolerability, tolerability `PHARMACOKINETIC`: Pharmacokinetic, PK, pk, Pharmacokinetics `PHARMACODYNAMIC`: Pharmacodynamic, PD, pd, Pharmacodynamics `BIOMARKER`: Biomarker, biomarker, Translational `PATIENT_REPORTED_OUTCOME`: PRO, Patient-reported, Patient reported outcome, Quality of life, QoL, HRQoL
objectives_and_endpoints.measurement	CONDITIONAL	ICH M11 §3.2; SPIRIT 2013 Item 12	Objectives and Endpoints Statistical Considerations Endpoint wording (GMT frequency)	Change from baseline ORR DOR HbA1c OS +5
Definition: REPEATING FIELD: return one value per objective or endpoint. The specific measurement or variable used (e.g. 'Overall Survival', 'HbA1c change'). Format: `Free text (array — one per parent entity)` Capture Guidance: Specify the exact variable being measured. Extraction Boundary: Extract the measurable endpoint variable or outcome metric only. Do not copy the broader endpoint description or the statistical analysis method. Examples: FOUND The protocol explicitly states the measurement: Example measurement. FOUND An abbreviated or edge-case statement still identifies the measurement: Abbrev measurement. NOT_FOUND This protocol section indicates the measurement does not apply for this study design.
objectives_and_endpoints.assessmentMethod	CONDITIONAL	ICH M11 §3.2; SPIRIT 2013 Item 12	Objectives and Endpoints Schedule of Activities Method statements (eDiary RT-PCR)	RECIST EORTC NRS Assessment VAS +6
Definition: The instrument, scale, or criteria used to measure the endpoint. Format: `Free text` Capture Guidance: Include specific instrument or criteria (e.g. 'RECIST v1.1'). Extraction Boundary: Extract only the value for assessmentMethod as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the assessmentMethod: Example assessmentMethod. FOUND An abbreviated or edge-case statement still identifies the assessmentMethod: Abbrev... NOT_FOUND This protocol section indicates the assessmentMethod does not apply for this study design.
objectives_and_endpoints.timepoint	CONDITIONAL	ICH M11 §3.2; SPIRIT 2013 Item 12	Objectives and Endpoints Schedule of Activities Endpoints specifying timepoint windows	Change from baseline Time to event At month At week Day 1-7 +2
Definition: REPEATING FIELD: return one value per objective or endpoint. When the endpoint is assessed relative to study timeline. Format: `Free text (array — one per parent entity)` Capture Guidance: Specify timing (e.g. 'at Week 12', 'from randomization to death'). Extraction Boundary: Extract only the value for timepoint as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the timepoint: Example timepoint. FOUND An abbreviated or edge-case statement still identifies the timepoint: Abbrev timepoint. NOT_FOUND This protocol section indicates the timepoint does not apply for this study design.
objectives_and_endpoints.windowLow	CONDITIONAL	ICH M11 §3.2	Objectives and Endpoints Statistical Considerations SOE windows if in endpoints	Window Minus Lower ± - +1
Definition: Lower bound of the assessment window for this endpoint. Format: `String or number` Capture Guidance: Assessment window lower bound (e.g. '-3 days'). Extraction Boundary: Extract only the value for windowLow as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the windowLow: Example windowLow. FOUND An abbreviated or edge-case statement still identifies the windowLow: Abbrev windowLow. NOT_FOUND This protocol section indicates the windowLow does not apply for this study design.
objectives_and_endpoints.windowHigh	CONDITIONAL	ICH M11 §3.2	Objectives and Endpoints Statistical Considerations SOE windows if in endpoints	Window Plus Upper ± + +1
Definition: Upper bound of the assessment window for this endpoint. Format: `String or number` Capture Guidance: Assessment window upper bound (e.g. '+3 days'). Extraction Boundary: Extract only the value for windowHigh as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the windowHigh: Example windowHigh. FOUND An abbreviated or edge-case statement still identifies the windowHigh: Abbrev windowHigh. NOT_FOUND This protocol section indicates the windowHigh does not apply for this study design.
objectives_and_endpoints.units	CONDITIONAL	CDISC SDTM	Objectives and Endpoints Endpoint unit terms (% titer)	mm months % Units titer +2
Definition: REPEATING FIELD: return one value per objective or endpoint. Units for the endpoint measurement. Format: `Free text (array — one per parent entity)` Capture Guidance: E.g. 'months', '%', 'mm'. Extraction Boundary: Extract only the value for units as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the units: Example units. FOUND An abbreviated or edge-case statement still identifies the units: Abbrev units. NOT_FOUND This protocol section indicates the units does not apply for this study design.
objectives_and_endpoints.statisticalMethod	CONDITIONAL	ICH M11 §10; SPIRIT 2013 Item 20a; ICH E9	Objectives and Endpoints Statistical Considerations Statistical analysis section	Log-rank ANCOVA Kaplan-Meier Logistic regression MMRM +4
Definition: The planned statistical analysis method for this endpoint. Format: `Free text` Capture Guidance: Describe the primary analysis including model and covariates. Extraction Boundary: Extract only the statistical analysis method named for the endpoint. Do not copy the endpoint description or measurement variable as the method. Examples: FOUND The protocol explicitly states the statisticalMethod: Example statisticalMethod. FOUND An abbreviated or edge-case statement still identifies the statisticalMethod: Abbrev... NOT_FOUND This protocol section indicates the statisticalMethod does not apply for this study design.
objectives_and_endpoints.activityRefsText	CONDITIONAL	ICH M11 §5	Objectives and Endpoints Schedule of Activities Endpoints referencing procedures/assessments	Assessment Procedure Activity assessments include measured by +1
Definition: REPEATING FIELD: return one value per objective or endpoint. Text references to the activities that measure this endpoint. Format: `Free text (array — one per parent entity)` Capture Guidance: Cross-reference to SoA activities that support this endpoint. Extraction Boundary: Extract only the value for activityRefsText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the activityRefsText: Example activityRefsText. FOUND An abbreviated or edge-case statement still identifies the activityRefsText: Abbrev... NOT_FOUND This protocol section indicates the activityRefsText does not apply for this study design.
objectives_and_endpoints.encounterRefsText	CONDITIONAL	ICH M11 §5; SPIRIT 2013 Item 13	Objectives and Endpoints Schedule of Activities Endpoints referencing visits/encounters	Encounter Visit At visit Day visit +3
Definition: REPEATING FIELD: return one value per objective or endpoint. Text references to the visits at which this endpoint is assessed. Format: `Free text (array — one per parent entity)` Capture Guidance: Cross-reference to the visits where this endpoint is measured. Extraction Boundary: Extract only the value for encounterRefsText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the encounterRefsText: Example encounterRefsText. FOUND An abbreviated or edge-case statement still identifies the encounterRefsText: Abbrev... NOT_FOUND This protocol section indicates the encounterRefsText does not apply for this study design.
objectives_and_endpoints.assumptionNotes	OPTIONAL	Internal	N/A (documentation)	assumed inferred not explicit
Definition: REPEATING FIELD: return one value per objective or endpoint. Assumptions made during extraction of this objective/endpoint. Format: `Free text (array — one per parent entity)` Capture Guidance: Document assumptions when protocol is ambiguous. Extraction Boundary: Extract only the value for assumptionNotes as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the assumptionNotes: Example assumptionNotes. FOUND An abbreviated or edge-case statement still identifies the assumptionNotes: Abbrev... NOT_FOUND This protocol section indicates the assumptionNotes does not apply for this study design.
objectives_and_endpoints.pageNumber	ALWAYS	Internal — auto-populated	Captured during extraction	p. pp.
Definition: Page number where objective/endpoint information was found. Format: `Integer` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageNumber: Example pageNumber. FOUND An abbreviated or edge-case statement still identifies the pageNumber: Abbrev pageNumber. NOT_FOUND The protocol does not explicitly state the pageNumber.

Population And Cohorts

14 fields

▼

Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
population_and_cohorts.populationId	SYSTEM	ICH M11 §5.1	Study Population N/A (System-Generated)	Cohort ID Population ID
Definition: Unique identifier for this population/cohort record. Format: `String` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for populationId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the populationId.
population_and_cohorts.populationName	ALWAYS	ICH M11 §5.1; SPIRIT 2013 Item 15	Study Population Study Design Synopsis Analysis Sets	Dose escalation cohort Sub-population Expansion cohort Population Cohort +8
Definition: REPEATING FIELD: return one value per population or cohort. The name or label of the study population or cohort. Format: `Free text string (array — one per parent entity)` Capture Guidance: Extract the names of ANALYSIS POPULATIONS (statistical groupings used for data analysis), not the study population description. Correct examples: 'Intent-to-Treat (ITT)', 'Modified ITT (mITT)', 'Per-Protocol (PP)', 'Safety Population', 'Full Analysis Set (FAS)', 'Dose Escalation Cohort', 'Expansion Cohort'. WRONG: 'Subjects with SLE', 'Adults aged 18-65 with moderate asthma' — these describe who enrolls in the study (eligibility), not the named analysis populations. If the protocol defines both enrollment criteria and named analysis sets, extract only the analysis set names. Use the exact name from the protocol. Extraction Boundary: Extract only the value for populationName as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the populationName: Example populationName. FOUND An abbreviated or edge-case statement still identifies the populationName: Abbrev... NOT_FOUND The protocol does not explicitly state the populationName.
population_and_cohorts.populationCategory	ALWAYS	ICH M11 §4.2; ICH E8(R1)	Study Population Study Design Analysis Sets Population Name	Dose escalation Dose expansion Sentinel Biomarker-selected Enrichment +9
Definition: Classification of the cohort type. Format: `Enum string` Capture Guidance: DOSE_ESCALATION for Phase 1 dose-finding. GENERAL for undifferentiated populations. Extraction Boundary: Extract only the value for populationCategory as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the populationCategory: DOSE_ESCALATION. FOUND An abbreviated or edge-case statement still identifies the populationCategory: DOSE_EXPANSION. NOT_FOUND The protocol does not explicitly state the populationCategory. Allowed Values: DOSE_ESCALATION DOSE_EXPANSION SENTINEL ENRICHMENT BIOMARKER_SELECTED GENERAL OTHER Value Aliases: `DOSE_ESCALATION`: Dose escalation, dose-escalation, Dose-finding cohort, DLT cohort `DOSE_EXPANSION`: Dose expansion, dose-expansion, Expansion cohort, Expansion `SENTINEL`: Sentinel, sentinel, Sentinel cohort, Safety run-in `ENRICHMENT`: Enrichment, Enriched, Biomarker-enriched `BIOMARKER_SELECTED`: Biomarker-selected, Biomarker positive, Molecularly selected `GENERAL`: General, All-comers, Unselected, ITT population
population_and_cohorts.description	ALWAYS	ICH M11 §5.1; SPIRIT 2013 Item 15	Study Population Study Design Eligibility Criteria Analysis Sets Definition Eligibility Intro	Cohort description Population description defined as includes consists of +2
Definition: Detailed description of the population/cohort. Format: `Free text` Capture Guidance: Describe what distinguishes this cohort from others. Extraction Boundary: Extract the cohort or population description only. Do not copy inclusion or exclusion criterion text line-by-line into this field. Examples: FOUND The protocol explicitly states the description: Example description. FOUND An abbreviated or edge-case statement still identifies the description: Abbrev description. NOT_FOUND The protocol does not explicitly state the description.
population_and_cohorts.plannedN	CONDITIONAL	ICH M11 §10.1; SPIRIT 2013 Item 14a	Statistical Considerations Study Population Synopsis Analysis Sets Statistical Section Synopsis Sample Size	Planned enrollment Approximately Cohort size N= approximately +4
Definition: The planned number of participants in this cohort. Format: `Integer` Capture Guidance: Extract the target size for this specific cohort. Extraction Boundary: Extract only the value for plannedN as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the plannedN: Example plannedN. FOUND An abbreviated or edge-case statement still identifies the plannedN: Abbrev plannedN. NOT_FOUND This protocol section indicates the plannedN does not apply for this study design.
population_and_cohorts.plannednType	ALWAYS	ICH M11 §10.1	Study Population Statistical Considerations	Approximately At least Up to Minimum Maximum
Definition: Type and scope of the planned N value. Combines precision qualifier (exact, approximate, minimum, maximum, range) with scope qualifier (total, per_arm, per_cohort). Format: `Enum string` Capture Guidance: APPROXIMATE if 'approximately' or '~' is used. EXACT for precise numbers. Extraction Boundary: Extract only the value for plannednType as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the plannednType: EXACT. FOUND An abbreviated or edge-case statement still identifies the plannednType: APPROXIMATE. NOT_FOUND The protocol does not explicitly state the plannednType. Allowed Values: EXACT APPROXIMATE MINIMUM MAXIMUM RANGE TOTAL PER_ARM PER_COHORT
population_and_cohorts.actualN	SYSTEM	ICH M11 §10.1	Study Population N/A (Post-Enrollment Data)	Actual enrollment Enrolled Accrual
Definition: Actual number of participants enrolled in this cohort (post-hoc). Format: `Integer` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for actualN as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the actualN.
population_and_cohorts.inclusionCriteriaIDs	CONDITIONAL	ICH M11 §5.1	Study Population Eligibility Criteria Population Definition	Inclusion criteria Eligible if inclusion criteria same as Pop_NNN meets eligibility
Definition: REPEATING FIELD: return one value per population or cohort. References to the inclusion criteria applicable to this cohort. Format: `List of strings (criterion IDs) (array — one per parent entity)` Capture Guidance: Link to eligibility_criteria records. May be all criteria or cohort-specific subset. Extraction Boundary: Extract only the value for inclusionCriteriaIDs as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the inclusionCriteriaIDs: ['Example item 1', 'Example item 2']. FOUND An abbreviated or edge-case statement still identifies the inclusionCriteriaIDs:... NOT_FOUND This protocol section indicates the inclusionCriteriaIDs does not apply for this study design.
population_and_cohorts.exclusionCriteriaIDs	CONDITIONAL	ICH M11 §5.1	Study Population Eligibility Criteria Population Definition	Excluded if Exclusion criteria exclusion criteria same as Pop_NNN
Definition: REPEATING FIELD: return one value per population or cohort. References to the exclusion criteria applicable to this cohort. Format: `List of strings (criterion IDs) (array — one per parent entity)` Capture Guidance: Link to eligibility_criteria records. Extraction Boundary: Extract only the value for exclusionCriteriaIDs as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the exclusionCriteriaIDs: ['Example item 1', 'Example item 2']. FOUND An abbreviated or edge-case statement still identifies the exclusionCriteriaIDs:... NOT_FOUND This protocol section indicates the exclusionCriteriaIDs does not apply for this study design.
population_and_cohorts.criteriaReferenceMode	ALWAYS	ICH M11 §5.1	Study Population Eligibility Criteria Analysis Sets definition Population Definition	Additional criteria Same criteria Modified criteria Same as received ≥1 dose
Definition: How eligibility criteria are referenced for this cohort (shared with study, cohort-specific, or modified). Format: `Enum string` Capture Guidance: SHARED if all cohorts use the same criteria. COHORT_SPECIFIC for unique criteria. Extraction Boundary: Extract only the value for criteriaReferenceMode as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the criteriaReferenceMode: SHARED. FOUND An abbreviated or edge-case statement still identifies the criteriaReferenceMode:... NOT_FOUND The protocol does not explicitly state the criteriaReferenceMode. Allowed Values: SHARED COHORT_SPECIFIC MODIFIED
population_and_cohorts.linkedArmIDs	ALWAYS	ICH M11 §4.2	Study Population Study Design Arms Arms Table Population Definition	all arms treatment groups
Definition: REPEATING FIELD: return one value per population or cohort. References to the study arms this population is assigned to. Format: `List of strings (array — one per parent entity)` Capture Guidance: Link population to arm(s). Each cohort may map to specific arms. Extraction Boundary: Extract only the value for linkedArmIDs as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the linkedArmIDs: ['Example item 1', 'Example item 2']. FOUND An abbreviated or edge-case statement still identifies the linkedArmIDs: ['Abbrev item']. NOT_FOUND The protocol does not explicitly state the linkedArmIDs.
population_and_cohorts.assumption	CONDITIONAL	Internal	N/A (Documentation Field)	—
Definition: REPEATING FIELD: return one value per population or cohort. Assumptions made during extraction of population data. Format: `Free text (array — one per parent entity)` Capture Guidance: Document assumptions when the protocol is ambiguous. Extraction Boundary: Extract only the value for assumption as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the assumption: Example assumption. FOUND An abbreviated or edge-case statement still identifies the assumption: Abbrev assumption. NOT_FOUND This protocol section indicates the assumption does not apply for this study design.
population_and_cohorts.notes	OPTIONAL	Internal	Study Population N/A (Documentation Field)	N/A
Definition: REPEATING FIELD: return one value per population or cohort. Additional notes about this population/cohort. Format: `Free text (array — one per parent entity)` Capture Guidance: Capture footnotes or additional context. Extraction Boundary: Extract only the value for notes as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the notes: Example notes. FOUND An abbreviated or edge-case statement still identifies the notes: Abbrev notes. NOT_FOUND This protocol section indicates the notes does not apply for this study design.
population_and_cohorts.pageNumber	ALWAYS	Internal — auto-populated	Captured during primary field extraction	—
Definition: Page number where population information was found. Format: `Integer` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageNumber: Example pageNumber. FOUND An abbreviated or edge-case statement still identifies the pageNumber: Abbrev pageNumber. NOT_FOUND The protocol does not explicitly state the pageNumber.

Protocol Version

18 fields

▼

Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
protocol_version.versionId	ALWAYS	ICH M11 §1	Title Page Cover Page Version History Header	Version ID Version Ver. Protocol Version Version No. +1
Definition: Short visible protocol version string used for this version record. Format: `String` Capture Guidance: Preserve the short visible version string from the protocol (for example, '2.0'). Extraction Boundary: Extract only the value for versionId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the versionId: Example versionId. FOUND An abbreviated or edge-case statement still identifies the versionId: Abbrev versionId. NOT_FOUND The protocol does not explicitly state the versionId.
protocol_version.versionNumber	ALWAYS	ICH M11 §1; SPIRIT 2013 Item 3	Title Page Synopsis Cover Page Version History Header	Version v1.0 Version number Protocol Version Version No. +1
Definition: The version number of the protocol document. Format: `String (e.g. '1.0', '3.2')` Capture Guidance: Take the latest version number from cover page or amendment history. Extraction Boundary: Extract only the value for versionNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the versionNumber: Example versionNumber. FOUND An abbreviated or edge-case statement still identifies the versionNumber: Abbrev versionNumber. NOT_FOUND The protocol does not explicitly state the versionNumber.
protocol_version.amendmentNumber	COND_PROTECTED	ICH M11 §1; SPIRIT 2013 Item 25	Title Page Synopsis Amendment Header Cover Page Version History	Amendment Amendment number Amendment No. Protocol Amendment Original +1
Definition: REPEATING FIELD: return one value per protocol version/amendment. The amendment number if the protocol has been amended. Format: `String (e.g. 'Amendment 1') (array — one per parent entity)` Capture Guidance: Extract from cover page or amendment history. Null if no amendments. Extraction Boundary: Extract only the value for amendmentNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the amendmentNumber: Example amendmentNumber. FOUND An abbreviated or edge-case statement still identifies the amendmentNumber: Abbrev... NOT_FOUND The protocol does not explicitly state the amendmentNumber.
protocol_version.approvalDate	COND_PROTECTED	ICH M11 §1; SPIRIT 2013 Item 3	Title Page Synopsis Signature Page Cover Page Approval Docs	Approval date Date approved Approved Approval Date IRB Approval +3
Definition: The date the protocol version was approved. Format: `ISO date string (YYYY-MM-DD)` Capture Guidance: Extract from cover page or signature page. Extraction Boundary: Extract only the value for approvalDate as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the approvalDate: 2026-03-13. FOUND An abbreviated or edge-case statement still identifies the approvalDate: 13 Mar 2026. NOT_FOUND This protocol section indicates the approvalDate does not apply for this study design.
protocol_version.effectiveDate	ALWAYS	ICH M11 §1	Title Page Synopsis Cover Page Version History Adjacent to Version	Effective date Implementation date Effective Effective Date Version Date +3
Definition: REPEATING FIELD: return one value per protocol version/amendment. The date the protocol version became effective. Format: `ISO date string (YYYY-MM-DD) (array — one per parent entity)` Capture Guidance: May differ from approval date; extract if stated. Extraction Boundary: Extract only the value for effectiveDate as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the effectiveDate: 2026-03-13. FOUND An abbreviated or edge-case statement still identifies the effectiveDate: 13 Mar 2026. NOT_FOUND The protocol does not explicitly state the effectiveDate.
protocol_version.reasonForAmendment	CONDITIONAL	ICH M11 §1; SPIRIT 2013 Item 25; ICH E6(R2) §4.5.2	Title Page Synopsis Amendment Summary Cover Page Change History	Amendment rationale Rationale Reason for amendment Reason for Amendment Summary of Changes +2
Definition: REPEATING FIELD: return one value per protocol version/amendment. The reason for the protocol amendment. Format: `Free text (array — one per parent entity)` Capture Guidance: Summarise the key reasons for the amendment. Extraction Boundary: Extract only the value for reasonForAmendment as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the reasonForAmendment: Example reasonForAmendment. FOUND An abbreviated or edge-case statement still identifies the reasonForAmendment: Abbrev... NOT_FOUND This protocol section indicates the reasonForAmendment does not apply for this study design.
protocol_version.sectionsModified	CONDITIONAL	ICH M11 §1; SPIRIT 2013 Item 25	Title Page Synopsis Amendment Summary Change Log TOC markers	Modified sections Changes Sections modified Sections Modified Sections Changed +2
Definition: REPEATING FIELD: return one value per protocol version/amendment. List of protocol sections modified in this amendment. Format: `List of strings or free text (array — one per parent entity)` Capture Guidance: List sections that were changed (e.g. 'Section 5.1 Inclusion Criteria'). Extraction Boundary: Extract only the value for sectionsModified as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the sectionsModified: ['Example item 1', 'Example item 2']. FOUND An abbreviated or edge-case statement still identifies the sectionsModified: ['Abbrev item']. NOT_FOUND This protocol section indicates the sectionsModified does not apply for this study design.
protocol_version.substantialChange	CONDITIONAL	EU CT Regulation Article 15; ICH E6(R2) §4.5.2	Title Page Synopsis Amendment Classification Regulatory Cover	Substantial amendment Substantial Non-substantial Substantial Change Major +1
Definition: REPEATING FIELD: return one value per protocol version/amendment. Whether the amendment constitutes a substantial change requiring regulatory notification. Format: `Boolean (array — one per parent entity)` Capture Guidance: true for amendments requiring regulatory re-approval. Extraction Boundary: Extract only the value for substantialChange as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the substantialChange: True. FOUND An abbreviated or edge-case statement still identifies the substantialChange: False. NOT_FOUND This protocol section indicates the substantialChange does not apply for this study design. Allowed Values: True False Value Aliases: `True`: Yes, Y, True, 1 `False`: No, N, False, 0
protocol_version.regulatoryStatus	COND_PROTECTED	ICH M11 §1	Title Page Cover Page Approval Docs Version History	Pending Under review Approved Status Approval Status +5
Definition: Current regulatory status of this protocol version. Format: `Enum string` Capture Guidance: Usually APPROVED for the current active version. Extraction Boundary: Extract only the value for regulatoryStatus as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the regulatoryStatus: APPROVED. FOUND An abbreviated or edge-case statement still identifies the regulatoryStatus: PENDING. NOT_FOUND This protocol section indicates the regulatoryStatus does not apply for this study design. Allowed Values: APPROVED PENDING UNDER_REVIEW WITHDRAWN
protocol_version.subjectsEnrolled	CONDITIONAL	ICH M11 §1	Title Page Synopsis Amendment Summary Enrollment Status Change Justification	Subjects enrolled At time of amendment Enrolled Subjects Enrolled Enrollment +1
Definition: Number of subjects enrolled at the time of this version/amendment. Format: `Integer` Capture Guidance: Often stated in amendment context (e.g. 'N=45 enrolled at time of amendment'). Extraction Boundary: Extract only the value for subjectsEnrolled as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the subjectsEnrolled: Example subjectsEnrolled. FOUND An abbreviated or edge-case statement still identifies the subjectsEnrolled: Abbrev... NOT_FOUND This protocol section indicates the subjectsEnrolled does not apply for this study design.
protocol_version.notes	OPTIONAL	Internal	Title Page N/A — Internal documentation	—
Definition: Additional notes about this protocol version. Format: `Free text` Capture Guidance: Capture additional context or caveats. Extraction Boundary: Extract only the value for notes as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the notes: Example notes. FOUND An abbreviated or edge-case statement still identifies the notes: Abbrev notes. NOT_FOUND This protocol section indicates the notes does not apply for this study design.
protocol_version.evidencePageNumbers	ALWAYS	Internal — extraction provenance	Title page Amendment history table	—
Definition: Page numbers where protocol version information was found. Format: `string` Extraction Boundary: Extract only the value for evidencePageNumbers as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the evidencePageNumbers: Example evidencePageNumbers. FOUND An abbreviated or edge-case statement still identifies the evidencePageNumbers: Abbrev... NOT_FOUND The protocol does not explicitly state the evidencePageNumbers.
protocol_version.isLatestByOrdering	SYSTEM	Internal — system-computed	—	—
Definition: Boolean flag indicating whether this is the latest version by ordering. Format: `string` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for isLatestByOrdering as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the isLatestByOrdering.
protocol_version.lifecycleStatus	COND_PROTECTED	ICH M11 §1; ICH E6(R2) §4.5	Title page Version history table Status field	status draft final approved
Definition: Current lifecycle status of this protocol version (e.g., DRAFT, FINAL, SUPERSEDED). Format: `Controlled term` Extraction Boundary: Extract only the value for lifecycleStatus as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the lifecycleStatus: Example lifecycleStatus. FOUND An abbreviated or edge-case statement still identifies the lifecycleStatus: Abbrev... NOT_FOUND This protocol section indicates the lifecycleStatus does not apply for this study design.
protocol_version.orderingMethod	SYSTEM	Internal — system configuration	—	—
Definition: Method used to determine version ordering (e.g., numeric, date-based). Format: `string` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for orderingMethod as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the orderingMethod.
protocol_version.versionIdentifier	ALWAYS	ICH M11 §1; SPIRIT 2013 Item 3	Title page Header Amendment table	Version Protocol Version Amendment
Definition: Full version identifier string as it appears in the protocol. Format: `Free text` Extraction Boundary: Extract only the value for versionIdentifier as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the versionIdentifier: Example versionIdentifier. FOUND An abbreviated or edge-case statement still identifies the versionIdentifier: Abbrev... NOT_FOUND The protocol does not explicitly state the versionIdentifier.
protocol_version.versionNotes	COND_PROTECTED	ICH E6(R2) §4.5	Amendment history Version notes	—
Definition: Free-text notes or comments about this protocol version. Format: `string` Extraction Boundary: Extract only the value for versionNotes as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the versionNotes: Example versionNotes. FOUND An abbreviated or edge-case statement still identifies the versionNotes: Abbrev versionNotes. NOT_FOUND This protocol section indicates the versionNotes does not apply for this study design.
protocol_version.versionNumberRaw	ALWAYS	Internal — extraction provenance	Title page Header	—
Definition: Raw version number as extracted before normalization. Format: `string` Extraction Boundary: Extract only the value for versionNumberRaw as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the versionNumberRaw: Example versionNumberRaw. FOUND An abbreviated or edge-case statement still identifies the versionNumberRaw: Abbrev... NOT_FOUND The protocol does not explicitly state the versionNumberRaw.

Safety Monitoring

12 fields

▼

Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
safety_monitoring.monitoringId	SYSTEM	ICH M11 §8	Safety Monitoring N/A (System-Generated)	—
Definition: Unique identifier for this safety monitoring record. Format: `String` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for monitoringId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the monitoringId.
safety_monitoring.type	ALWAYS	ICH M11 §8; SPIRIT 2013 Item 22	Safety Monitoring Safety Monitoring section Adverse Events section Study Procedures	AE DSMB SUSAR Safety review Type +8
Definition: Type of safety monitoring activity. Format: `Enum string` Capture Guidance: Classify by the type of safety oversight body or reporting mechanism, not by a generic monitoring activity. When the protocol describes an independent committee (DSMB, DMC, SRC, Safety Review Committee), classify as DSMB_REVIEW. When it describes SAE/SUSAR reporting procedures, classify as SAE_REPORTING or SUSAR_REPORTING. Do not default to AE_MONITORING when a more specific category applies — AE_MONITORING is for routine adverse event collection procedures only, not for committee-based oversight or expedited reporting workflows. Extraction Boundary: Extract only the value for type as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the type: AE_MONITORING. FOUND An abbreviated or edge-case statement still identifies the type: SAE_REPORTING. NOT_FOUND The protocol does not explicitly state the type. Allowed Values: AE_MONITORING SAE_REPORTING DSMB_REVIEW SUSAR_REPORTING DLT_ASSESSMENT PREGNANCY_REPORTING SAFETY_LAB OTHER Value Aliases: `AE_MONITORING`: Adverse event monitoring, AE monitoring, AE collection, Adverse event collection `SAE_REPORTING`: SAE reporting, Serious adverse event, SAE, Serious AE `DSMB_REVIEW`: DSMB, DMC, Data Safety Monitoring Board, Data Monitoring Committee, DSMB review `SUSAR_REPORTING`: SUSAR, Suspected unexpected, SUSAR reporting, Expedited reporting `DLT_ASSESSMENT`: DLT, Dose-limiting toxicity, DLT assessment, Dose limiting `PREGNANCY_REPORTING`: Pregnancy, Pregnancy reporting, WOCBP `SAFETY_LAB`: Safety laboratory, Safety labs, Lab monitoring, Laboratory monitoring
safety_monitoring.description	ALWAYS	ICH M11 §8; SPIRIT 2013 Item 22	Safety Monitoring Complete monitoring description Methodology narrative Safety assessment details	Safety monitoring SAE reporting DSMB Adverse event monitoring +5
Definition: Detailed description of the safety monitoring activity. Format: `Free text` Capture Guidance: Describe the monitoring activity including procedures and responsibilities. Extraction Boundary: Extract only the value for description as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the description: Example description. FOUND An abbreviated or edge-case statement still identifies the description: Abbrev description. NOT_FOUND The protocol does not explicitly state the description.
safety_monitoring.schedule	ALWAYS	ICH M11 §8; SPIRIT 2013 Item 22	Safety Monitoring Schedule specification in monitoring table Frequency description Assessment timing	Frequency Meeting frequency Review schedule Schedule daily +7
Definition: The schedule or frequency of safety monitoring reviews. Format: `Free text` Capture Guidance: Describe when safety reviews occur (e.g. 'After every 3 patients', 'Quarterly'). Extraction Boundary: Extract only the value for schedule as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the schedule: Example schedule. FOUND An abbreviated or edge-case statement still identifies the schedule: Abbrev schedule. NOT_FOUND The protocol does not explicitly state the schedule.
safety_monitoring.reportingWindow	ALWAYS	ICH M11 §8.3; ICH E6(R2) §4.11.1; ICH E2A	Safety Monitoring Reporting requirements section Safety reporting SAE procedures	Expedited 24 hours Reporting window Within Initial report +6
Definition: Required timeline for reporting safety events. Format: `Free text` Capture Guidance: Standard SAE reporting is 24 hours. SUSARs: 7 days fatal, 15 days others. Extraction Boundary: Extract only the value for reportingWindow as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the reportingWindow: Example reportingWindow. FOUND An abbreviated or edge-case statement still identifies the reportingWindow: Abbrev... NOT_FOUND The protocol does not explicitly state the reportingWindow.
safety_monitoring.escalationCriteria	ALWAYS	ICH M11 §8; SPIRIT 2013 Item 11b	Safety Monitoring Study Design Escalation criteria section Dose modification criteria Stopping rules	Escalation Safety boundary Stopping rule Dose-limiting DLT +7
Definition: Criteria that trigger escalation of safety concerns. Format: `Free text` Capture Guidance: Describe triggers for dose holds, study stops, or DSMB convening. Extraction Boundary: Extract only the value for escalationCriteria as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the escalationCriteria: Example escalationCriteria. FOUND An abbreviated or edge-case statement still identifies the escalationCriteria: Abbrev... NOT_FOUND The protocol does not explicitly state the escalationCriteria.
safety_monitoring.gradingScale	ALWAYS	ICH M11 §8; ICH E6(R2) §4.11	Safety Monitoring Grading criteria section AE grading Safety monitoring methodology	Severity scale CTCAE Grade 1-5 NCI-CTCAE Grading +6
Definition: The grading scale used for adverse event severity assessment. Format: `Free text (e.g. 'NCI-CTCAE v5.0')` Capture Guidance: Specify the grading scale and version. Extraction Boundary: Extract only the value for gradingScale as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the gradingScale: Example gradingScale. FOUND An abbreviated or edge-case statement still identifies the gradingScale: Abbrev gradingScale. NOT_FOUND The protocol does not explicitly state the gradingScale.
safety_monitoring.action	ALWAYS	ICH M11 §8; ICH E6(R2) §4.11	Safety Monitoring Action/response section Management procedures Dose modification actions	Discontinuation Action Dose modification Dose hold Treatment interruption +7
Definition: Actions to be taken in response to safety events. Format: `Free text` Capture Guidance: Extract the procedural action type triggered by the safety event — the notification or operational response, not the clinical intervention. Examples: 'Notify sponsor within 24 hours', 'Unblind treatment assignment', 'Suspend dosing pending DSMB review', 'Report to IRB/ethics committee'. Do NOT extract rescue therapy details, concomitant medication instructions, or clinical management procedures — those belong in the rescueTherapy or description fields. Focus on WHO must be notified, WHAT operational step is triggered, and WHEN. Extraction Boundary: Extract only the value for action as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the action: Example action. FOUND An abbreviated or edge-case statement still identifies the action: Abbrev action. NOT_FOUND The protocol does not explicitly state the action.
safety_monitoring.endpointParameter	ALWAYS	ICH M11 §8	Safety Monitoring Safety Monitoring parameter list Laboratory section Assessment details	Neutrophils AST Parameter Endpoint Hy's Law +8
Definition: The specific safety parameter being monitored (e.g. liver enzymes, QTc). Format: `Free text` Capture Guidance: Specify the monitored parameter. Extraction Boundary: Extract only the value for endpointParameter as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the endpointParameter: Example endpointParameter. FOUND An abbreviated or edge-case statement still identifies the endpointParameter: Abbrev... NOT_FOUND The protocol does not explicitly state the endpointParameter.
safety_monitoring.encounterId	ALWAYS	ICH M11 §8	Schedule of Activities Safety Monitoring Monitoring schedule specification SOA column headers Visit descriptions	at all visits Visit Encounter Day Week +2
Definition: Reference to the encounter at which this monitoring occurs. Format: `String` Capture Guidance: Link to the encounter/visit record if monitoring is visit-specific. Extraction Boundary: Extract only the value for encounterId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the encounterId: Example encounterId. FOUND An abbreviated or edge-case statement still identifies the encounterId: Abbrev encounterId. NOT_FOUND The protocol does not explicitly state the encounterId.
safety_monitoring.assumptionNotes	OPTIONAL	Internal	N/A — Agent-generated documentation not extracted from protocol	—
Definition: Assumptions made during extraction of safety monitoring data. Format: `Free text` Capture Guidance: Document assumptions when the protocol is ambiguous. Extraction Boundary: Extract only the value for assumptionNotes as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the assumptionNotes: Example assumptionNotes. FOUND An abbreviated or edge-case statement still identifies the assumptionNotes: Abbrev... NOT_FOUND This protocol section indicates the assumptionNotes does not apply for this study design.
safety_monitoring.pageNumber	ALWAYS	Internal — auto-populated	Auto-capture during extraction record page(s) where monitoring defined	Page numbers auto-captured during extraction process
Definition: Page number where safety monitoring information was found. Format: `Integer` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageNumber: Example pageNumber. FOUND An abbreviated or edge-case statement still identifies the pageNumber: Abbrev pageNumber. NOT_FOUND The protocol does not explicitly state the pageNumber.

Soa Activity

12 fields

▼

Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
soa_activity.activityId	SYSTEM	ICH M11 §5	Schedule of Activities N/A (System-generated)	—
Definition: Reference to the parent activity record. Format: `String` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for activityId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the activityId.
soa_activity.activityProcedure	ALWAYS	ICH M11 §6; SPIRIT 2013 Item 13	SOA table row labels procedure names	procedure assessment test sample
Definition: The procedure or activity name from the SOA row label. Format: `Free text` Extraction Boundary: Extract only the value for activityProcedure as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the activityProcedure: Example activityProcedure. FOUND An abbreviated or edge-case statement still identifies the activityProcedure: Abbrev... NOT_FOUND The protocol does not explicitly state the activityProcedure.
soa_activity.activityCategory	ALWAYS	ICH M11 §6 (Schedule of Activities); CDISC SDTM TA/TV	SOA table Schedule of Activities row group header	category group section header
Definition: Category grouping for the activity row in the Schedule of Activities table. Format: `Controlled term (SAFETY, EFFICACY, PK, PD, BIOMARKER, ADMINISTRATIVE)` Extraction Boundary: Extract only the value for activityCategory as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the activityCategory: Example activityCategory. FOUND An abbreviated or edge-case statement still identifies the activityCategory: Abbrev... NOT_FOUND The protocol does not explicitly state the activityCategory.
soa_activity.categorySequence	SYSTEM	Internal — system-generated ordering	SOA table category order	—
Definition: Ordering sequence of the category within the SOA table. Format: `string` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for categorySequence as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the categorySequence.
soa_activity.description	CONDITIONAL	ICH M11 §5	Schedule of Activities Study Procedures Description column Notes column	Description Notes Details
Definition: Description of what is done for this SoA activity. Format: `Free text` Capture Guidance: Additional detail beyond the procedure name. Extraction Boundary: Extract only the value for description as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the description: Example description. FOUND An abbreviated or edge-case statement still identifies the description: Abbrev description. NOT_FOUND This protocol section indicates the description does not apply for this study design.
soa_activity.visitHeaderText	CONDITIONAL	ICH M11 §6; SPIRIT 2013 Figure	SOA table column headers visit names	—
Definition: Column header text for visit columns in the SOA table. Format: `Free text (visit label)` Extraction Boundary: Extract only the value for visitHeaderText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the visitHeaderText: Example visitHeaderText. FOUND An abbreviated or edge-case statement still identifies the visitHeaderText: Abbrev... NOT_FOUND This protocol section indicates the visitHeaderText does not apply for this study design.
soa_activity.visitScheduleText	ALWAYS	ICH M11 §6; SPIRIT 2013 Figure	SOA table cells X marks checkmarks	—
Definition: REPEATING FIELD: return one value per SoA activity row. Cell content indicating whether activity is performed at each visit (X, ✓, conditional text). Format: `Cell content (X, ✓, text, or empty) (array — one per parent entity)` Extraction Boundary: Extract only the value for visitScheduleText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the visitScheduleText: Example visitScheduleText. FOUND An abbreviated or edge-case statement still identifies the visitScheduleText: Abbrev... NOT_FOUND The protocol does not explicitly state the visitScheduleText.
soa_activity.footnoteMarkersUsed	CONDITIONAL	ICH M11 §6; SPIRIT 2013 Figure	SOA table cells superscript markers	footnote superscript * †
Definition: Footnote marker symbols (e.g., , a, 1) used in this SOA row. Format:* `Comma-separated list of markers` Extraction Boundary: Extract only the value for footnoteMarkersUsed as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the footnoteMarkersUsed: ['Example item 1', 'Example item 2']. FOUND An abbreviated or edge-case statement still identifies the footnoteMarkersUsed:... NOT_FOUND This protocol section indicates the footnoteMarkersUsed does not apply for this study design.
soa_activity.footnoteText	CONDITIONAL	ICH M11 §6	SOA table footer footnotes section	footnote note
Definition: Full text of footnotes associated with this SOA activity row. Format: `Free text` Extraction Boundary: Extract only the value for footnoteText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the footnoteText: Example footnoteText. FOUND An abbreviated or edge-case statement still identifies the footnoteText: Abbrev footnoteText. NOT_FOUND This protocol section indicates the footnoteText does not apply for this study design.
soa_activity.assumptionNotes	CONDITIONAL	Internal — extraction provenance	SOA table footnotes protocol text	—
Definition: REPEATING FIELD: return one value per SoA activity row. Extraction assumptions or notes about this SOA activity row. Format: `string (array — one per parent entity)` Extraction Boundary: Extract only the value for assumptionNotes as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the assumptionNotes: Example assumptionNotes. FOUND An abbreviated or edge-case statement still identifies the assumptionNotes: Abbrev... NOT_FOUND This protocol section indicates the assumptionNotes does not apply for this study design.
soa_activity.pageNumber	ALWAYS	Internal — auto-populated	SOA table page(s)	p. pp. Page
Definition: Page number where SoA activity was found. Format: `Integer` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageNumber: Example pageNumber. FOUND An abbreviated or edge-case statement still identifies the pageNumber: Abbrev pageNumber. NOT_FOUND The protocol does not explicitly state the pageNumber.
soa_activity.pageSection	CONDITIONAL	Internal — auto-populated	SOA section title	Schedule SOE Table
Definition: Section heading where SoA activity was found. Format: `Free text` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageSection as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageSection: Example pageSection. FOUND An abbreviated or edge-case statement still identifies the pageSection: Abbrev pageSection. NOT_FOUND This protocol section indicates the pageSection does not apply for this study design.

Soa Visit

7 fields

▼

Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
soa_visit.visitId	SYSTEM	ICH M11 §5	Schedule of Activities N/A (System-generated)	—
Definition: Reference to the encounters_and_visits record this SoA column represents. Format: `String` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for visitId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the visitId.
soa_visit.visitName	ALWAYS	ICH M11 §5; SPIRIT 2013 Item 13	Schedule of Activities SOA column headers Visit Schedule Study Design	EOT Visit Week Screening Day +5
Definition: The column header label as displayed in the SoA table. Format: `Free text string` Capture Guidance: Use the exact column header from the SoA table. Extraction Boundary: Extract only the value for visitName as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the visitName: Example visitName. FOUND An abbreviated or edge-case statement still identifies the visitName: Abbrev visitName. NOT_FOUND The protocol does not explicitly state the visitName.
soa_visit.visitOrder	SYSTEM	Internal	Schedule of Activities SOA column headers (L R order)	Column position (left-to-right)
Definition: Chronological order of this visit column in the SoA. Format: `Integer` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for visitOrder as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the visitOrder.
soa_visit.contextType	CONDITIONAL	ICH M11 §5; SPIRIT 2013 Item 13	Schedule of Activities SOA section headers Column groupings	Day Event Week Month Period +4
Definition: The type of timing context for this SoA column (day, week, month, event). Format: `Enum string` Capture Guidance: DAY if column header uses study days. WEEK for study weeks. EVENT for milestone visits. Extraction Boundary: Extract only the value for contextType as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the contextType: DAY. FOUND An abbreviated or edge-case statement still identifies the contextType: WEEK. NOT_FOUND This protocol section indicates the contextType does not apply for this study design. Allowed Values: DAY WEEK MONTH EVENT OTHER Value Aliases: `DAY`: Day, day, Study day, D, Study Day `WEEK`: Week, week, Study week, W, Wk `MONTH`: Month, month, Mo, Study month `EVENT`: Event, event, Milestone, EOT, EOS, ET
soa_visit.contextValue	CONDITIONAL	ICH M11 §5	Schedule of Activities Context header Grouping labels	Numbers/letters following context type
Definition: The specific timing value for this SoA column (e.g. '1', '4', '12'). Format: `String or integer` Capture Guidance: Extract the numeric part (e.g. from 'Day 28' → '28', from 'Week 4' → '4'). Extraction Boundary: Extract only the value for contextValue as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the contextValue: Example contextValue. FOUND An abbreviated or edge-case statement still identifies the contextValue: Abbrev contextValue. NOT_FOUND This protocol section indicates the contextValue does not apply for this study design.
soa_visit.pageNumber	ALWAYS	Internal — auto-populated	SOA table page(s) Visit Schedule section	p. pp. Page
Definition: Page number where SoA visit column was found. Format: `Integer` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageNumber: Example pageNumber. FOUND An abbreviated or edge-case statement still identifies the pageNumber: Abbrev pageNumber. NOT_FOUND The protocol does not explicitly state the pageNumber.
soa_visit.pageSection	CONDITIONAL	Internal — auto-populated	SOA section title Table caption	Schedule of Events SOE Schedule of Activities
Definition: Section heading where SoA visit column was found. Format: `Free text` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageSection as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageSection: Example pageSection. FOUND An abbreviated or edge-case statement still identifies the pageSection: Abbrev pageSection. NOT_FOUND This protocol section indicates the pageSection does not apply for this study design.

Study Cells

13 fields

▼

Field	Extraction Mode	Standard Ref	Search Zones	Keywords (sample)
study_cells.cellId	SYSTEM	CDISC SDTM TA; ICH M11 §4.2	Study Design N/A (System fallback)	Cell ID
Definition: Unique identifier for this study cell record. Format: `String` Capture Guidance: SYSTEM field -- do not extract from protocol. Auto-populated by downstream system. Extraction Boundary: Extract only the value for cellId as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: NOT_FOUND The protocol does not explicitly state the cellId.
study_cells.cellName	ALWAYS	CDISC SDTM TA; ICH M11 §4.2	Study Design Arms SOE 'Study Cells/Schema' Schematic figures	Arm-epoch Cell study cell cell schema +1
Definition: Descriptive name of the study cell (combination of arm and epoch). Format: `Free text string` Capture Guidance: Constructed as 'Arm Name — Epoch Name'. Extraction Boundary: Extract only the value for cellName as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the cellName: Example cellName. FOUND An abbreviated or edge-case statement still identifies the cellName: Abbrev cellName. NOT_FOUND The protocol does not explicitly state the cellName.
study_cells.descriptionText	ALWAYS	CDISC SDTM TA; ICH M11 §4.2	Study Design Arms Cell narrative in table/footnote	Cell description Treatment assignment includes consists of will be performed
Definition: REPEATING FIELD: return one value per study cell (epoch×arm combination). Description of what happens in this study cell. Format: `Free text (array — one per parent entity)` Capture Guidance: Describe intervention(s) and assessments in this arm-epoch combination. Extraction Boundary: Extract only the value for descriptionText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the descriptionText: Example descriptionText. FOUND An abbreviated or edge-case statement still identifies the descriptionText: Abbrev... NOT_FOUND The protocol does not explicitly state the descriptionText.
study_cells.purposeText	CONDITIONAL	CDISC SDTM TA	Study Design Cell header lines ('Purpose' 'Objective')	Purpose Cell purpose purpose to in order to
Definition: REPEATING FIELD: return one value per study cell (epoch×arm combination). The purpose of this study cell. Format: `Free text (array — one per parent entity)` Capture Guidance: E.g. 'Assess efficacy of Drug A at 100mg during treatment period'. Extraction Boundary: Extract only the value for purposeText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the purposeText: Example purposeText. FOUND An abbreviated or edge-case statement still identifies the purposeText: Abbrev purposeText. NOT_FOUND This protocol section indicates the purposeText does not apply for this study design.
study_cells.armRefsText	ALWAYS	CDISC SDTM TA	Study Design Arms SOE arm columns/rows Randomization section	Treatment arm Arm Group All arms Cohort
Definition: REPEATING FIELD: return one value per study cell (epoch×arm combination). Text reference to the arm this cell belongs to. Format: `Free text (array — one per parent entity)` Capture Guidance: Name or ID of the arm for this cell. Extraction Boundary: Extract only the value for armRefsText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the armRefsText: Example armRefsText. FOUND An abbreviated or edge-case statement still identifies the armRefsText: Abbrev armRefsText. NOT_FOUND The protocol does not explicitly state the armRefsText.
study_cells.epochRefsText	ALWAYS	CDISC SDTM TA	Study Design SOE epoch bands Study Duration/Periods	Period Epoch Screening Treatment Follow-up
Definition: Text reference to the epoch this cell belongs to. Format: `Free text` Capture Guidance: Name or ID of the epoch for this cell. Extraction Boundary: Extract only the value for epochRefsText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the epochRefsText: Example epochRefsText. FOUND An abbreviated or edge-case statement still identifies the epochRefsText: Abbrev epochRefsText. NOT_FOUND The protocol does not explicitly state the epochRefsText.
study_cells.interventionRefsText	CONDITIONAL	CDISC SDTM TA; ICH M11 §4.3	Study Design Interventions Treatments/Interventions section SOE treatment row	Treatment Intervention Drug treatment vaccine +1
Definition: REPEATING FIELD: return one value per study cell (epoch×arm combination). Text references to the interventions administered in this cell. Format: `Free text (array — one per parent entity)` Capture Guidance: Name(s) of intervention(s) for this arm-epoch. Extraction Boundary: Extract only the value for interventionRefsText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the interventionRefsText: Example interventionRefsText. FOUND An abbreviated or edge-case statement still identifies the interventionRefsText:... NOT_FOUND This protocol section indicates the interventionRefsText does not apply for this study design.
study_cells.activityRefsText	CONDITIONAL	ICH M11 §5	Schedule of Activities Study Design SOE procedures/assessments Schedule footnotes	Assessment Activity assessments procedures activities +1
Definition: Text references to the activities performed in this cell. Format: `Free text` Capture Guidance: Cross-reference to activities in this arm-epoch. Extraction Boundary: Extract only the value for activityRefsText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the activityRefsText: Example activityRefsText. FOUND An abbreviated or edge-case statement still identifies the activityRefsText: Abbrev... NOT_FOUND This protocol section indicates the activityRefsText does not apply for this study design.
study_cells.durationText	CONDITIONAL	ICH M11 §4.2; CDISC SDTM TA	Study Design SOE headers/footnotes with day ranges	Duration Cycles Months Weeks Day +4
Definition: The planned duration of this study cell. Format: `String with unit (e.g. '12 weeks')` Capture Guidance: Duration of this specific arm-epoch combination. Extraction Boundary: Extract only the value for durationText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the durationText: Example durationText. FOUND An abbreviated or edge-case statement still identifies the durationText: Abbrev durationText. NOT_FOUND This protocol section indicates the durationText does not apply for this study design.
study_cells.transitionRuleText	CONDITIONAL	CDISC SDTM TE; ICH M11 §4.2	Study Design SOE footnotes + visit progression text	Discontinue Complete Criteria Transition transition +3
Definition: REPEATING FIELD: return one value per study cell (epoch×arm combination). Rule governing transition from this cell to the next. Format: `Free text (array — one per parent entity)` Capture Guidance: Describe conditions for ending this cell and entering the next. Extraction Boundary: Extract only the value for transitionRuleText as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the transitionRuleText: Example transitionRuleText. FOUND An abbreviated or edge-case statement still identifies the transitionRuleText: Abbrev... NOT_FOUND This protocol section indicates the transitionRuleText does not apply for this study design.
study_cells.assumptionNotes	OPTIONAL	Internal	N/A (documentation)	assumed not explicit kept as text
Definition: Assumptions made during study cell extraction. Format: `Free text` Capture Guidance: Document assumptions when protocol is ambiguous. Extraction Boundary: Extract only the value for assumptionNotes as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the assumptionNotes: Example assumptionNotes. FOUND An abbreviated or edge-case statement still identifies the assumptionNotes: Abbrev... NOT_FOUND This protocol section indicates the assumptionNotes does not apply for this study design.
study_cells.pageNumber	ALWAYS	Internal — auto-populated	Captured during extraction	p. pp.
Definition: Page number where study cell information was found. Format: `Integer` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageNumber as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageNumber: Example pageNumber. FOUND An abbreviated or edge-case statement still identifies the pageNumber: Abbrev pageNumber. NOT_FOUND The protocol does not explicitly state the pageNumber.
study_cells.pageSection	ALWAYS	Internal — auto-populated	SOE section title Table caption	SOE Schedule Study Schema Activities
Definition: Section heading where study cell information was found. Format: `Free text` Capture Guidance: Auto-populated during extraction. Extraction Boundary: Extract only the value for pageSection as defined here. Do not merge adjacent fields or surrounding narrative unless it directly states the field value. Examples: FOUND The protocol explicitly states the pageSection: Example pageSection. FOUND An abbreviated or edge-case statement still identifies the pageSection: Abbrev pageSection. NOT_FOUND The protocol does not explicitly state the pageSection.

🧭 Cortex Tier Policy cortex_tier_policy_3_0.yaml

Domain Processing Order

▼

#	Domain	Phase	Depends On	Must Complete Before
1	study_design_and_definition	Phase 1	—	study_design, arms, epochs, interventions
2	arms	Phase 2	study_design_and_definition.numberOfArms, study_design_and_definition.interventionModel	study_cells, interventions
3	epochs	Phase 2	study_design_and_definition	encounters_and_visits, study_cells
4	crossover_design	Phase 2	study_design_and_definition.interventionModel	study_cells
5	interventions	Phase 2	arms	study_cells, safety_monitoring
6	population_and_cohorts	Phase 2	study_design_and_definition	eligibility_criteria
7	eligibility_criteria	Phase 3	population_and_cohorts	—
8	encounters_and_visits	Phase 3	epochs	soa_visit, soa_activity
9	activities	Phase 3	—	soa_activity, objectives_and_endpoints
10	soa_visit	Phase 4	encounters_and_visits	study_cells
11	soa_activity	Phase 4	activities, soa_visit	—
12	study_cells	Phase 4	arms, epochs, interventions	—
13	objectives_and_endpoints	Phase 5	activities, encounters_and_visits	—
14	safety_monitoring	Phase 5	encounters_and_visits, interventions	—
15	protocol_version	Phase 1	—	—

Per-Field Tier Routing

239 fields ▼

Field	Allowed Tiers	T3 Self-Critique	T4 on Disagreement
study_design_and_definition.id	tier1, tier3, tier4	✓	✓
study_design_and_definition.name	tier3, tier4	✓	✓
study_design_and_definition.protocolVersion	tier1, tier3, tier4	✓	✓
study_design_and_definition.protocolDate	tier1, tier3, tier4	✓	✓
study_design_and_definition.sponsor	tier3, tier4	✓	✓
study_design_and_definition.regulatoryIdentifier	tier1, tier3, tier4	✓	✓
study_design_and_definition.trialRegistryIdentifier	tier1, tier3, tier4	✓	✓
study_design_and_definition.usdmVersion	tier1, tier3, tier4	✓	✓
study_design_and_definition.rationale	tier3, tier4	✓	✓
study_design_and_definition.studyType	tier1, tier3, tier4	✓	✓
study_design_and_definition.trialType	tier3, tier4	✓	✓
study_design_and_definition.phaseCode	tier1, tier3, tier4	✓	✓
study_design_and_definition.studyPhase	tier3, tier4	✓	✓
study_design_and_definition.interventionModel	tier1, tier3, tier4	✓	✓
study_design_and_definition.interventionType	tier3, tier4	✓	✓
study_design_and_definition.allocation	tier1, tier3, tier4	✓	✓
study_design_and_definition.allocationRatio	tier3, tier4	✓	✓
study_design_and_definition.randomizationMethod	tier3, tier4	✓	✓
study_design_and_definition.stratificationFactors	tier3, tier4	✓	✓
study_design_and_definition.blindingSchema	tier1, tier3, tier4	✓	✓
study_design_and_definition.studyTypeMasking	tier3, tier4	✓	✓
study_design_and_definition.controlType	tier3, tier4	✓	✓
study_design_and_definition.numberOfArms	tier3, tier4	✓	✓
study_design_and_definition.studyArms	tier3, tier4	✓	✓
study_design_and_definition.observationalModel	tier3, tier4	✓	✓
study_design_and_definition.targetEnrollment	tier3, tier4	✓	✓
study_design_and_definition.populationAgeRange	tier3, tier4	✓	✓
study_design_and_definition.therapeuticAreas	tier3, tier4	✓	✓
study_design_and_definition.studyDuration	tier3, tier4	✓	✓
study_design_and_definition.participantDuration	tier3, tier4	✓	✓
study_design_and_definition.screeningPeriod	tier3, tier4	✓	✓
study_design_and_definition.treatmentPeriod	tier3, tier4	✓	✓
study_design_and_definition.followUpPeriod	tier3, tier4	✓	✓
study_design_and_definition.primaryCompletionType	tier3, tier4	✓	✓
study_design_and_definition.dataMonitoringCommittee	tier3, tier4	✓	✓
study_design_and_definition.doseEscalationSchema	tier3, tier4	✓	✓
study_design_and_definition.hyperglycemiaRescueCriteria	tier3, tier4	✓	✓
study_design_and_definition.interimAnalysis	tier3, tier4	✓	✓
study_design_and_definition.maskingRoles	tier3, tier4	✓	✓
study_design_and_definition.primaryEstimand	tier3, tier4	✓	✓
study_design_and_definition.rescueTherapy	tier3, tier4	✓	✓
study_design_and_definition.screeningTarget	tier3, tier4	✓	✓
arms.armId	tier3, tier4	✓	✓
arms.armName	tier3, tier4	✓	✓
arms.armType	tier3, tier4	✓	✓
arms.description	tier3, tier4	✓	✓
arms.interventions	tier3, tier4	✓	✓
arms.sampleSize	tier3, tier4	✓	✓
arms.treatmentDuration	tier3, tier4	✓	✓
arms.sequenceCrossover	tier3, tier4	✓	✓
arms.notes	tier3, tier4	✓	✓
arms.pageNumber	tier3, tier4	✓	✓
arms.pageSection	tier3, tier4	✓	✓
activities.activityId	tier3, tier4	✓	✓
activities.activityName	tier3, tier4	✓	✓
activities.activityLabel	tier3, tier4	✓	✓
activities.description	tier3, tier4	✓	✓
activities.dataType	tier3, tier4	✓	✓
activities.collectionMethod	tier3, tier4	✓	✓
activities.specimenType	tier3, tier4	✓	✓
activities.frequency	tier3, tier4	✓	✓
activities.units	tier3, tier4	✓	✓
activities.normalRange	tier3, tier4	✓	✓
activities.assumption	tier3, tier4	✓	✓
activities.notes	tier3, tier4	✓	✓
activities.pageNumber	tier3, tier4	✓	✓
activities.pageSection	tier3, tier4	✓	✓
activities.activityCategory	tier3, tier4	✓	✓
activities.activityProcedure	tier3, tier4	✓	✓
activities.assumptionNotes	tier3, tier4	✓	✓
activities.categorySequence	tier3, tier4	✓	✓
activities.footnoteMarkersUsed	tier3, tier4	✓	✓
activities.footnoteText	tier3, tier4	✓	✓
activities.visitHeaderText	tier3, tier4	✓	✓
activities.visitScheduleText	tier3, tier4	✓	✓
crossover_design.sequenceId	tier3, tier4	✓	✓
crossover_design.sequenceName	tier3, tier4	✓	✓
crossover_design.sequencePattern	tier3, tier4	✓	✓
crossover_design.description	tier3, tier4	✓	✓
crossover_design.numberOfPeriods	tier3, tier4	✓	✓
crossover_design.periodInterventions	tier3, tier4	✓	✓
crossover_design.washoutDuration	tier3, tier4	✓	✓
crossover_design.randomizationRatio	tier3, tier4	✓	✓
crossover_design.blockSize	tier3, tier4	✓	✓
crossover_design.balancingFactor	tier3, tier4	✓	✓
crossover_design.expectedN	tier3, tier4	✓	✓
crossover_design.pageNumber	tier3, tier4	✓	✓
crossover_design.pageSection	tier3, tier4	✓	✓
eligibility_criteria.criterionId	tier3, tier4	✓	✓
eligibility_criteria.category	tier3, tier4	✓	✓
eligibility_criteria.text	tier3, tier4	✓	✓
eligibility_criteria.identifier	tier3, tier4	✓	✓
eligibility_criteria.structured	tier3, tier4	✓	✓
eligibility_criteria.operator	tier3, tier4	✓	✓
eligibility_criteria.value	tier3, tier4	✓	✓
eligibility_criteria.units	tier3, tier4	✓	✓
eligibility_criteria.timeframe	tier3, tier4	✓	✓
eligibility_criteria.negationFlag	tier3, tier4	✓	✓
eligibility_criteria.assumption	tier3, tier4	✓	✓
eligibility_criteria.notes	tier3, tier4	✓	✓
eligibility_criteria.pageNumber	tier3, tier4	✓	✓
encounters_and_visits.encId	tier3, tier4	✓	✓
encounters_and_visits.encounterName	tier3, tier4	✓	✓
encounters_and_visits.visitLabel	tier3, tier4	✓	✓
encounters_and_visits.purpose	tier3, tier4	✓	✓
encounters_and_visits.epochReference	tier3, tier4	✓	✓
encounters_and_visits.studyDay	tier3, tier4	✓	✓
encounters_and_visits.windowMinus	tier3, tier4	✓	✓
encounters_and_visits.windowPlus	tier3, tier4	✓	✓
encounters_and_visits.duration	tier3, tier4	✓	✓
encounters_and_visits.mode	tier3, tier4	✓	✓
encounters_and_visits.location	tier3, tier4	✓	✓
encounters_and_visits.required	tier3, tier4	✓	✓
encounters_and_visits.overnightStay	tier3, tier4	✓	✓
encounters_and_visits.labsRequired	tier3, tier4	✓	✓
encounters_and_visits.activitiesPerformed	tier3, tier4	✓	✓
encounters_and_visits.pageNumber	tier3, tier4	✓	✓
encounters_and_visits.pageSection	tier3, tier4	✓	✓
epochs.epochId	tier3, tier4	✓	✓
epochs.epochName	tier3, tier4	✓	✓
epochs.epochType	tier3, tier4	✓	✓
epochs.purpose	tier3, tier4	✓	✓
epochs.duration	tier3, tier4	✓	✓
epochs.sequenceInStudy	tier3, tier4	✓	✓
epochs.transitionRule	tier3, tier4	✓	✓
epochs.notes	tier3, tier4	✓	✓
epochs.pageNumber	tier3, tier4	✓	✓
epochs.pageSection	tier3, tier4	✓	✓
interventions.interventionId	tier3, tier4	✓	✓
interventions.name	tier3, tier4	✓	✓
interventions.label	tier3, tier4	✓	✓
interventions.type	tier3, tier4	✓	✓
interventions.description	tier3, tier4	✓	✓
interventions.dose	tier3, tier4	✓	✓
interventions.doseUnits	tier3, tier4	✓	✓
interventions.frequency	tier3, tier4	✓	✓
interventions.route	tier3, tier4	✓	✓
interventions.formulation	tier3, tier4	✓	✓
interventions.duration	tier3, tier4	✓	✓
interventions.crossoverPeriod	tier3, tier4	✓	✓
interventions.manufacturer	tier3, tier4	✓	✓
interventions.indNumber	tier3, tier4	✓	✓
interventions.assumptionNotes	tier3, tier4	✓	✓
interventions.pageNumber	tier3, tier4	✓	✓
interventions.pageSection	tier3, tier4	✓	✓
objectives_and_endpoints.oeId	tier3, tier4	✓	✓
objectives_and_endpoints.name	tier3, tier4	✓	✓
objectives_and_endpoints.recordType	tier3, tier4	✓	✓
objectives_and_endpoints.level	tier3, tier4	✓	✓
objectives_and_endpoints.description	tier3, tier4	✓	✓
objectives_and_endpoints.purpose	tier3, tier4	✓	✓
objectives_and_endpoints.measurement	tier3, tier4	✓	✓
objectives_and_endpoints.assessmentMethod	tier3, tier4	✓	✓
objectives_and_endpoints.timepoint	tier3, tier4	✓	✓
objectives_and_endpoints.windowLow	tier3, tier4	✓	✓
objectives_and_endpoints.windowHigh	tier3, tier4	✓	✓
objectives_and_endpoints.units	tier3, tier4	✓	✓
objectives_and_endpoints.statisticalMethod	tier3, tier4	✓	✓
objectives_and_endpoints.activityRefsText	tier3, tier4	✓	✓
objectives_and_endpoints.encounterRefsText	tier3, tier4	✓	✓
objectives_and_endpoints.assumptionNotes	tier3, tier4	✓	✓
objectives_and_endpoints.pageNumber	tier3, tier4	✓	✓
population_and_cohorts.populationId	tier3, tier4	✓	✓
population_and_cohorts.populationName	tier3, tier4	✓	✓
population_and_cohorts.populationCategory	tier3, tier4	✓	✓
population_and_cohorts.description	tier3, tier4	✓	✓
population_and_cohorts.plannedN	tier3, tier4	✓	✓
population_and_cohorts.plannednType	tier3, tier4	✓	✓
population_and_cohorts.actualN	tier3, tier4	✓	✓
population_and_cohorts.inclusionCriteriaIDs	tier3, tier4	✓	✓
population_and_cohorts.exclusionCriteriaIDs	tier3, tier4	✓	✓
population_and_cohorts.criteriaReferenceMode	tier3, tier4	✓	✓
population_and_cohorts.linkedArmIDs	tier3, tier4	✓	✓
population_and_cohorts.assumption	tier3, tier4	✓	✓
population_and_cohorts.notes	tier3, tier4	✓	✓
population_and_cohorts.pageNumber	tier3, tier4	✓	✓
population_and_cohorts.plannedN_type	tier3, tier4	✓	✓
protocol_version.versionId	tier3, tier4	✓	✓
protocol_version.versionNumber	tier3, tier4	✓	✓
protocol_version.amendmentNumber	tier3, tier4	✓	✓
protocol_version.approvalDate	tier3, tier4	✓	✓
protocol_version.effectiveDate	tier3, tier4	✓	✓
protocol_version.reasonForAmendment	tier3, tier4	✓	✓
protocol_version.sectionsModified	tier3, tier4	✓	✓
protocol_version.substantialChange	tier3, tier4	✓	✓
protocol_version.regulatoryStatus	tier3, tier4	✓	✓
protocol_version.subjectsEnrolled	tier3, tier4	✓	✓
protocol_version.notes	tier3, tier4	✓	✓
protocol_version.evidencePageNumbers	tier3, tier4	✓	✓
protocol_version.isLatestByOrdering	tier3, tier4	✓	✓
protocol_version.lifecycleStatus	tier3, tier4	✓	✓
protocol_version.orderingMethod	tier3, tier4	✓	✓
protocol_version.versionIdentifier	tier3, tier4	✓	✓
protocol_version.versionNotes	tier3, tier4	✓	✓
protocol_version.versionNumberRaw	tier3, tier4	✓	✓
safety_monitoring.monitoringId	tier3, tier4	✓	✓
safety_monitoring.type	tier3, tier4	✓	✓
safety_monitoring.description	tier3, tier4	✓	✓
safety_monitoring.schedule	tier3, tier4	✓	✓
safety_monitoring.reportingWindow	tier3, tier4	✓	✓
safety_monitoring.escalationCriteria	tier3, tier4	✓	✓
safety_monitoring.gradingScale	tier3, tier4	✓	✓
safety_monitoring.action	tier3, tier4	✓	✓
safety_monitoring.endpointParameter	tier3, tier4	✓	✓
safety_monitoring.encounterId	tier3, tier4	✓	✓
safety_monitoring.assumptionNotes	tier3, tier4	✓	✓
safety_monitoring.pageNumber	tier3, tier4	✓	✓
soa_activity.activityId	tier3, tier4	✓	✓
soa_activity.activityProcedure	tier3, tier4	✓	✓
soa_activity.activityCategory	tier3, tier4	✓	✓
soa_activity.categorySequence	tier3, tier4	✓	✓
soa_activity.description	tier3, tier4	✓	✓
soa_activity.visitHeaderText	tier3, tier4	✓	✓
soa_activity.visitScheduleText	tier3, tier4	✓	✓
soa_activity.footnoteMarkersUsed	tier3, tier4	✓	✓
soa_activity.footnoteText	tier3, tier4	✓	✓
soa_activity.assumptionNotes	tier3, tier4	✓	✓
soa_activity.pageNumber	tier3, tier4	✓	✓
soa_activity.pageSection	tier3, tier4	✓	✓
soa_visit.visitId	tier3, tier4	✓	✓
soa_visit.visitName	tier3, tier4	✓	✓
soa_visit.visitOrder	tier3, tier4	✓	✓
soa_visit.contextType	tier3, tier4	✓	✓
soa_visit.contextValue	tier3, tier4	✓	✓
soa_visit.pageNumber	tier3, tier4	✓	✓
soa_visit.pageSection	tier3, tier4	✓	✓
study_cells.cellId	tier3, tier4	✓	✓
study_cells.cellName	tier3, tier4	✓	✓
study_cells.descriptionText	tier3, tier4	✓	✓
study_cells.purposeText	tier3, tier4	✓	✓
study_cells.armRefsText	tier3, tier4	✓	✓
study_cells.epochRefsText	tier3, tier4	✓	✓
study_cells.interventionRefsText	tier3, tier4	✓	✓
study_cells.activityRefsText	tier3, tier4	✓	✓
study_cells.durationText	tier3, tier4	✓	✓
study_cells.transitionRuleText	tier3, tier4	✓	✓
study_cells.assumptionNotes	tier3, tier4	✓	✓
study_cells.pageNumber	tier3, tier4	✓	✓
study_cells.pageSection	tier3, tier4	✓	✓

⚙️ Agent Configurations agent_configs_2_1.yaml

Design Agent

Protocol Extraction v2_cascade ▼

Models

active

['ollama-ministral3-14b']

optional

[]

tier4_model

ollama-qwen35

tier2_model_dir

models/cortex_tier2/current

tier2_cross_encoder

cross-encoder/ms-marco-MiniLM-L-12-v2

tier2_allow_remote_download

False

Tier Cascade

enable_t1: OFF enable_t2: OFF enable_t3: ON enable_t4: ON

API Budgets

tier3 / max_api_calls_per_run

tier3 / max_input_tokens_per_run

500000

tier3 / max_concurrent_calls

tier3 / timeout_per_call_s

180

tier3 / fallback_attempts

tier4 / max_api_calls_per_run

tier4 / max_input_tokens_per_run

200000

tier4 / max_cost_per_run_usd

0.5

tier4 / max_concurrent_calls

tier4 / timeout_per_call_s

180

tier4 / fallback_attempts

tier4 / reasoning_effort

none

total / max_api_calls_per_job

total / max_wall_clock_s

300

total / max_total_cost_usd

2.0

Confidence Thresholds

t2_applicability

0.45

t2_line_score

0.3

t2_field_examples

0.5

0.4

ai_fallback

0.7

conflict_discount

0.15

Batching

t3_batch_size

t3_parallel_groups

t3_parallel_models

t4_batch_size

t4_parallel_batches

General Settings

temperature

0.1

require_evidence

True

Schema Agent

Normalization ▼

General Settings

target_model

USDM v4.0

Mapping Agent

SDTM Mapping ▼

General Settings

input

Validated, approved USDM v4.0 JSON (from Validator Agent)

Validator Agent

Cross-Agent Validation ▼

General Settings

input

Schema Agent USDM v4.0 JSON with CT mappings and confidence scores

strict_blocking

True

Amendment Agent

Diff Detection ▼

General Settings

input

New protocol version (PDF/DOCX) + previous version's USDM JSON

✅ Validation Rules validation_rules_3_0.yaml

Field Validation Rules

239 fields ▼

Field	Reviewer Triggers	Blocking Conditions	System Fill	Allowed Values Enforcement
study_design_and_definition.id	Unexpected location, unusual format, low confidence	—	—	—
study_design_and_definition.name	Very short title (<30 chars), assembled from multiple sources, found only in header	—	—	—
study_design_and_definition.protocolVersion	Ambiguous version. Multiple candidates. Historical vs current unclear.	—	—	—
study_design_and_definition.protocolDate	Estimated date. Partial date. Multiple candidates. No clear version association.	—	CALC-DATE: Date Normalization	—
study_design_and_definition.sponsor	Uncertain sponsor identity. Possible CRO confusion. No title page presence.	—	—	—
study_design_and_definition.regulatoryIdentifier	V-096: Both regulatory and registry IDs missing. Invalid ID format.	—	—	—
study_design_and_definition.trialRegistryIdentifier	V-096: Both regulatory and registry IDs missing. Invalid format.	—	—	—
study_design_and_definition.usdmVersion	N/A — system value always valid.	—	—	—
study_design_and_definition.rationale	No rationale found. Very brief (<200 chars). Missing key elements. Literature only.	—	—	—
study_design_and_definition.studyType	V-050: Derived studyType inconsistent. Multiple components missing. \| CONFLICT (signals for multiple types), inferred from weak signals, no explicit statement	—	CALC-STUDYTYPE: Study Type Derivation	✓
study_design_and_definition.trialType	V-061: trialType for observational (info only). V-090: trialType = interventionType (confused).	—	—	✓
study_design_and_definition.phaseCode	Conflicting explicit phases across sections OR phase only in low-priority sections OR any inferred-without-token attempt	—	CALC-025: Combined Phase Detail	✓
study_design_and_definition.studyPhase	Phase derivation uncertain. phaseCode was inferred or unclear.	—	CALC-025: Phase Derivation	—
study_design_and_definition.interventionModel	V-030: Both interventionModel and observationalModel NOT_NULL. V-033: SINGLE_GROUP but numberOfArms ≠ 1.	—	—	✓
study_design_and_definition.interventionType	V-062: interventionType for OBSERVATIONAL. Multiple unclear types.	—	—	✓
study_design_and_definition.allocation	MIXED allocation, inferred from structure, no explicit statement	—	CALC-024: MIXED Allocation Detail	✓
study_design_and_definition.allocationRatio	V-044: Ratio parts ≠ numberOfArms. V-045: Ratio specified for non-randomized study.	—	CALC-010: Ratio Parse CALC-011: Ratio-Arm Validation	—
study_design_and_definition.randomizationMethod	V-042: stratificationFactors present but method not STRATIFIED. V-043: STRATIFIED but no factors. UNKNOWN for randomized study.	—	—	—
study_design_and_definition.stratificationFactors	V-042: Factors present without STRATIFIED method. V-043: STRATIFIED without factors. V-046: Factors for non-randomized.	—	—	—
study_design_and_definition.blindingSchema	V-027: blindingSchema conflicts with studyTypeMasking. Blinded study with no mechanism found.	—	CALC-012: Masking Coherence CALC-013: Allocation-Blind Check CALC-014: Arm-Blind Check	✓
study_design_and_definition.studyTypeMasking	UNKNOWN masking. Conflicting statements. Single-arm with blinding claim. Observational with masking.	—	—	—
study_design_and_definition.controlType	V-063: controlType for single-arm. Type unclear.	—	—	✓
study_design_and_definition.numberOfArms	V-073: numberOfArms < 1. V-074: numberOfArms > 20. Unresolved discrepancy between sources.	—	CALC-006: Explicit Count CALC-007: Ratio-based Count CALC-008: Enumeration Count CALC-008B: Conflict Resolution	—
study_design_and_definition.studyArms	V-051: Arm count ≠ numberOfArms. Incomplete arm descriptions.	—	CALC-015: Arm Count Validation	—
study_design_and_definition.observationalModel	V-030: observationalModel for INTERVENTIONAL. Model unclear.	—	—	✓
study_design_and_definition.targetEnrollment	V-075: enrollment < 1. V-076: enrollment > 100,000. Sum ≠ arm allocations.	—	CALC-009: Enrollment Sum CALC-009B: Range Handling	—
study_design_and_definition.populationAgeRange	V-070: minAge < 0. V-071: maxAge > 120. V-072: minAge ≥ maxAge. Conflicting age statements.	—	CALC-021: Age Range Parse CALC-022: Pediatric Flag CALC-023: Age Validation	—
study_design_and_definition.therapeuticAreas	No disease identified. Drug name as disease. Non-standard terminology. Single generic term.	—	—	—
study_design_and_definition.studyDuration	Duration conflict with participant duration. Implausible duration. Conversion uncertainty.	—	CALC-001: Duration Normalization	—
study_design_and_definition.participantDuration	V-080: Derived ≠ stated ±7 days. V-081: participantDuration > studyDuration. Missing components.	—	CALC-003: Component Sum CALC-004: Explicit vs Derived CALC-005: Coherence Check CALC-020: ISO Conversion	—
study_design_and_definition.screeningPeriod	Screening duration inconsistent with visit schedule. Very long screening (>56 days).	—	CALC-001: Duration Normalization CALC-002: Day-Range Conversion	—
study_design_and_definition.treatmentPeriod	Treatment duration inconsistent with study design. Very short or very long.	—	CALC-001: Duration Normalization CALC-002: Cycle Calculation	—
study_design_and_definition.followUpPeriod	Follow-up longer than study duration. P0D for study requiring safety monitoring.	—	CALC-001: Duration Normalization CALC-003: Post-Treatment Calculation	—
study_design_and_definition.primaryCompletionType	Completion unclear or inconsistent with endpoints.	—	—	—
study_design_and_definition.dataMonitoringCommittee	Value not in allowed set (YES/NO/NOT_APPLICABLE). Ambiguous DMC reference.	—	—	✓
study_design_and_definition.doseEscalationSchema	Escalation only described in figure (no text). Conflicting escalation schedules across sections.	—	—	—
study_design_and_definition.hyperglycemiaRescueCriteria	Rescue criteria only partially stated. Thresholds ambiguous or inconsistent across sections.	—	—	—
study_design_and_definition.interimAnalysis	Interim analysis described but decision rules unclear. Ad hoc vs pre-specified ambiguous.	—	—	—
study_design_and_definition.maskingRoles	Discrepancy: blindingSchema level vs number of masked roles listed. Advisory blinding unclear.	—	—	✓
study_design_and_definition.primaryEstimand	Estimand components incomplete. Pre-E9(R1) terminology requiring interpretation. Multiple estimands with unclear primary.	—	—	—
study_design_and_definition.rescueTherapy	Rescue criteria unclear. Rescue medications listed without trigger thresholds.	—	—	—
study_design_and_definition.screeningTarget	V-077: screeningTarget < targetEnrollment (unusual). Screening number confused with enrollment.	—	—	—
arms.armId	V-ARM-001: Pattern mismatch; V-ARM-002: Duplicate armId	—	CALC-ARM-001 (ArmID Fallback)	—
arms.armName	V-ARM-003: armName IS NULL or EMPTY	—	—	—
arms.armType	armType inferred (not stated)	—	—	✓
arms.description	Description is global or NULL	—	—	—
arms.interventions	Interventions invented	—	—	—
arms.sampleSize	sampleSize uses total N	—	—	—
arms.treatmentDuration	Duration uses epoch duration	—	—	—
arms.sequenceCrossover	Sequence invented	—	—	—
arms.notes	Assumptions in notes	—	—	—
arms.pageNumber	W-ARM-010: pageNumber NULL	—	—	—
arms.pageSection	pageSection NULL	—	—	—
activities.activityId	Duplicate IDs / bad pattern	—	CALC-ACT-001	—
activities.activityName	activityName NULL	—	—	—
activities.activityLabel	—	—	—	—
activities.description	description empty	—	—	—
activities.dataType	—	—	—	—
activities.collectionMethod	—	—	—	—
activities.specimenType	—	—	—	—
activities.frequency	—	—	—	—
activities.units	—	—	—	—
activities.normalRange	—	—	—	—
activities.assumption	—	—	—	—
activities.notes	—	—	—	—
activities.pageNumber	pageNumber NULL	—	—	—
activities.pageSection	pageSection NULL	—	—	—
activities.activityCategory	activityCategory IS NULL \| Ambiguous grouping, mixed categories in one section	—	—	—
activities.activityProcedure	Ambiguous procedure name	V-SOA-002: activityProcedure IS NULL or EMPTY	—	—
activities.assumptionNotes	Significant assumption made	—	—	—
activities.categorySequence	N/A	—	CALC-SOA-CAT-SEQ	—
activities.footnoteMarkersUsed	W-SOA-020: EMPTY but visitScheduleText contains superscripts \| Markers found but no corresponding footnote text	—	—	—
activities.footnoteText	W-SOA-040: footnoteMarkersUsed NOT EMPTY but footnoteText IS NULL \| Marker present but no matching footnote text	—	—	—
activities.visitHeaderText	Merged column headers, ambiguous visit labels	V-SOA-003: visitHeaderText IS NULL or EMPTY	—	—
activities.visitScheduleText	Conditional text requires interpretation	V-SOA-004: visitScheduleText IS NULL or EMPTY	—	—
crossover_design.sequenceId	V-CROSS-001: Pattern mismatch; V-CROSS-002: Duplicate	—	CALC-CROSS-001 (SequenceID Fallback)	—
crossover_design.sequenceName	V-CROSS-003: Name is NULL or empty	—	—	—
crossover_design.sequencePattern	W-CROSS-013: Pattern is NULL	—	—	—
crossover_design.description	—	—	—	—
crossover_design.numberOfPeriods	—	—	—	—
crossover_design.periodInterventions	W-CROSS-012: NULL	—	—	—
crossover_design.washoutDuration	W-CROSS-014: NULL	—	—	—
crossover_design.randomizationRatio	—	—	—	—
crossover_design.blockSize	—	—	—	—
crossover_design.balancingFactor	—	—	—	—
crossover_design.expectedN	—	—	—	—
crossover_design.pageNumber	W-CROSS-010: NULL	—	—	—
crossover_design.pageSection	W-CROSS-011: NULL	—	—	—
eligibility_criteria.criterionId	HARD FAIL: Pattern mismatch, duplicate ID, sequence gap, restart at exclusion	HARD FAIL: Pattern mismatch, duplicate ID, sequence gap, restart at exclusion	CALC-EC-001	—
eligibility_criteria.category	HARD FAIL: NULL or invalid value	HARD FAIL: NULL or invalid value	CALC-EC-002	✓
eligibility_criteria.text	HARD FAIL: Empty or NULL; WARNING: Paraphrased	HARD FAIL: Empty or NULL; WARNING: Paraphrased	—	—
eligibility_criteria.identifier	WARNING: Invented identifier	—	—	—
eligibility_criteria.structured	WARNING: Over-structured qualitative criterion	—	—	✓
eligibility_criteria.operator	HARD FAIL: Invalid code; WARNING: NULL when value present	HARD FAIL: Invalid code; WARNING: NULL when value present	CALC-EC-003	—
eligibility_criteria.value	WARNING: Uncertain value; HARD FAIL if invented	WARNING: Uncertain value; HARD FAIL if invented	—	—
eligibility_criteria.units	WARNING: Inferred unit	—	CALC-EC-005	—
eligibility_criteria.timeframe	WARNING: Normalized instead of verbatim	—	CALC-EC-006	—
eligibility_criteria.negationFlag	WARNING: Negation ambiguous	—	CALC-EC-004	✓
eligibility_criteria.assumption	WARNING: Missing for ambiguous extraction	—	—	—
eligibility_criteria.notes	WARNING: Mixed with assumption	—	—	—
eligibility_criteria.pageNumber	WARNING: Missing page number	—	—	—
encounters_and_visits.encId	V-ENC-001: Pattern mismatch; V-ENC-002: Duplicate	—	CALC-ENC-001	—
encounters_and_visits.encounterName	V-ENC-003: NULL or EMPTY	—	—	—
encounters_and_visits.visitLabel	Label invented	—	—	—
encounters_and_visits.purpose	Purpose too generic	—	—	—
encounters_and_visits.epochReference	Epoch_NNN used	—	—	—
encounters_and_visits.studyDay	W-ENC-011: studyDay NULL	—	—	—
encounters_and_visits.windowMinus	W-ENC-012: window NULL	—	—	—
encounters_and_visits.windowPlus	W-ENC-012: window NULL	—	—	—
encounters_and_visits.duration	Duration estimated	—	—	—
encounters_and_visits.mode	Mode assumed	—	—	✓
encounters_and_visits.location	Location assumed	—	—	—
encounters_and_visits.required	Required assumed	Required assumed	—	✓
encounters_and_visits.overnightStay	Overnight assumed	—	—	✓
encounters_and_visits.labsRequired	Labs status unclear	—	—	✓
encounters_and_visits.activitiesPerformed	W-ENC-013: activitiesPerformed NULL	—	—	—
encounters_and_visits.pageNumber	W-ENC-010: pageNumber NULL	—	—	—
encounters_and_visits.pageSection	pageSection NULL	—	—	—
epochs.epochId	V-EPO-001: Pattern mismatch; V-EPO-002: Duplicate epochId	—	CALC-EPOCH-001 (EpochID Fallback)	—
epochs.epochName	V-EPO-003: epochName IS NULL or EMPTY	—	—	—
epochs.epochType	epochType inferred	—	—	✓
epochs.purpose	Purpose guessed	—	—	—
epochs.duration	W-EPO-011: duration NULL	—	—	—
epochs.sequenceInStudy	V-EPO-004: Duplicate or gap (1,2,4 invalid)	—	—	—
epochs.transitionRule	Transition invented	—	—	—
epochs.notes	Assumptions in notes	—	—	—
epochs.pageNumber	W-EPO-010: pageNumber NULL	—	—	—
epochs.pageSection	pageSection NULL	—	—	—
interventions.interventionId	V-INT-001: Pattern; V-INT-002: Duplicate	—	CALC-INT-001 (InterventionID Fallback)	—
interventions.name	V-INT-003: name NULL (blocking)	V-INT-003: name NULL (blocking)	—	—
interventions.label	—	—	—	—
interventions.type	—	—	—	✓
interventions.description	W-INT-011: description empty	—	—	—
interventions.dose	—	—	—	—
interventions.doseUnits	W-INT-010: orphan units (doseUnits without dose)	—	—	—
interventions.frequency	—	—	—	—
interventions.route	—	—	—	✓
interventions.formulation	—	—	—	—
interventions.duration	—	—	—	—
interventions.crossoverPeriod	W-INT-013: crossoverPeriod NOT NULL in non-crossover	—	—	—
interventions.manufacturer	—	—	—	—
interventions.indNumber	—	—	—	—
interventions.assumptionNotes	—	—	—	—
interventions.pageNumber	V-INT-010: pageNumber NULL (blocking)	V-INT-010: pageNumber NULL (blocking)	—	—
interventions.pageSection	W-INT-012: NULL	—	—	—
objectives_and_endpoints.oeId	V-OE-002: oeId pattern mismatch	—	CALC-OE-001 (oeId fallback)	—
objectives_and_endpoints.name	V-OE-003: name NULL	—	—	—
objectives_and_endpoints.recordType	V-OE-001: recordType NULL/invalid	—	—	✓
objectives_and_endpoints.level	V-OE-004: level NULL/unclear	—	—	✓
objectives_and_endpoints.description	W-OE-010: description too short	—	—	—
objectives_and_endpoints.purpose	V-OE-005: purpose NULL/unclear	—	—	✓
objectives_and_endpoints.measurement	W-OE-040: measurement missing	—	—	—
objectives_and_endpoints.assessmentMethod	W-OE-042: method missing	—	—	—
objectives_and_endpoints.timepoint	W-OE-030: timepoint missing	—	—	—
objectives_and_endpoints.windowLow	W-OE-031: windows missing when implied	—	—	—
objectives_and_endpoints.windowHigh	W-OE-031: windows missing when implied	—	—	—
objectives_and_endpoints.units	W-OE-041: units missing	—	—	—
objectives_and_endpoints.statisticalMethod	W-OE-043: stats missing	—	—	—
objectives_and_endpoints.activityRefsText	W-OE-021: activityRefsText looks like Act_###	—	—	—
objectives_and_endpoints.encounterRefsText	W-OE-020: encounterRefsText looks like Enc_###	—	—	—
objectives_and_endpoints.assumptionNotes	W-OE-050: assumptions expected but missing	—	—	—
objectives_and_endpoints.pageNumber	V-OE-100: pageNumber missing	—	—	—
population_and_cohorts.populationId	V-100: Pop_NNN pattern mismatch; V-101: Duplicate populationId within study	—	—	—
population_and_cohorts.populationName	V-102: populationName required (NULL not acceptable)	V-102: populationName required (NULL not acceptable)	—	—
population_and_cohorts.populationCategory	V-117: Invalid category; V-118: More than one BASE; W-240: No BASE found	—	—	✓
population_and_cohorts.description	W-211: description NULL or < 20 chars (definition may be incomplete)	—	—	—
population_and_cohorts.plannedN	W-200: PlannedN vs targetEnrollment mismatch (may be valid for overlapping populations)	—	CALC-POP-001 (PlannedN Derivation)	—
population_and_cohorts.plannednType	—	—	—	—
population_and_cohorts.actualN	W-230: actualN NOT NULL during protocol extraction (should be NULL at this stage)	—	—	—
population_and_cohorts.inclusionCriteriaIDs	V-110: CriteriaIDs exist check (only if mode=EXPLICIT_IDS); V-119: Empty when mode=EXPLICIT_IDS	—	—	—
population_and_cohorts.exclusionCriteriaIDs	V-110: CriteriaIDs exist check; V-119: Empty when mode=EXPLICIT_IDS	—	—	—
population_and_cohorts.criteriaReferenceMode	V-119: CriteriaIDs empty when mode=EXPLICIT_IDS; V-120: CriteriaIDs present when mode≠EXPLICIT_IDS; W-241: mode=DERIVED_LOGIC AND notes/assumption empty	—	—	✓
population_and_cohorts.linkedArmIDs	V-111: ArmIDs exist; V-113: ArmIDs must be Arm_NNN pattern only (no "All arms" text)	—	—	—
population_and_cohorts.assumption	W-220: criteriaReferenceMode=DERIVED_LOGIC AND notes/assumption empty (prose criteria should be documented)	—	—	—
population_and_cohorts.notes	W-220: criteriaReferenceMode=DERIVED_LOGIC AND notes/assumption empty	—	—	—
population_and_cohorts.pageNumber	W-210: pageNumber NULL or empty (audit trail incomplete)	—	—	—
population_and_cohorts.plannedN_type	Ambiguous whether exact or approximate	—	—	—
protocol_version.versionId	V-PV-001: Pattern mismatch; V-PV-003: Duplicate versionId within study	—	CALC-PV-001 (Version ID Generation)	—
protocol_version.versionNumber	V-PV-002: versionNumberRaw required (NULL not acceptable)	V-PV-002: versionNumberRaw required (NULL not acceptable)	CALC-PV-002 (Version Alignment)	—
protocol_version.amendmentNumber	Ambiguous amendment/version distinction	—	CALC-PV-003 (Amendment-Version Alignment)	—
protocol_version.approvalDate	W-PV-014: approvalDate NULL (no signature/approval page found)	—	CALC-PV-008 (Approval-Effective Order)	—
protocol_version.effectiveDate	W-PV-010: Date present but not parseable (set NULL with warning)	—	CALC-PV-004 (Date Normalization) + CALC-PV-005 (Sequence Check)	—
protocol_version.reasonForAmendment	W-PV-015: amendmentSequence > 0 AND reason NULL (should have documented reason)	—	—	—
protocol_version.sectionsModified	Empty sections for non-Original amendment (may be valid but review)	—	—	—
protocol_version.substantialChange	V-PV-006: Value NOT IN (Yes, No, N/A) is invalid	—	CALC-PV-006 (Substantial Change Classification)	✓
protocol_version.regulatoryStatus	V-PV-005: regulatoryStatus NOT IN valid enum	—	—	✓
protocol_version.subjectsEnrolled	W-PV-012: subjectsEnrolled NULL (not stated for this version)	—	CALC-PV-007 (Enrollment Progression)	—
protocol_version.notes	—	—	—	—
protocol_version.evidencePageNumbers	pageNumbers NULL \| Version info found in unexpected location	—	—	—
protocol_version.isLatestByOrdering	N/A	—	—	—
protocol_version.lifecycleStatus	Status ambiguous between draft and final	—	—	—
protocol_version.orderingMethod	N/A	—	—	—
protocol_version.versionIdentifier	versionIdentifier NULL \| Multiple conflicting version identifiers found	—	—	—
protocol_version.versionNotes	Notes present but context unclear	—	—	—
protocol_version.versionNumberRaw	Non-standard version format	—	—	—
safety_monitoring.monitoringId	Duplicate ID detected; Pattern mismatch; Sequence gap	—	CALC-SAF-001	—
safety_monitoring.type	Generic label; inferred type; low confidence extraction	—	—	✓
safety_monitoring.description	Incomplete; assembled; missing key elements	—	—	—
safety_monitoring.schedule	Inferred schedule; partial description; ambiguous timing	—	—	—
safety_monitoring.reportingWindow	Inferred window; partial specification; ambiguous urgency	—	—	—
safety_monitoring.escalationCriteria	Inferred criteria; incomplete; missing operators or thresholds	—	—	—
safety_monitoring.gradingScale	Inferred scale; inappropriate NULL for AE monitoring; wrong scale type	—	—	—
safety_monitoring.action	Inferred action; incomplete; generic response	—	—	—
safety_monitoring.endpointParameter	Partial list; inferred parameters; mixed safety/efficacy	—	—	—
safety_monitoring.encounterId	Partial references; inferred encounters; unvalidated IDs	—	—	—
safety_monitoring.assumptionNotes	Vague assumption; no basis; unclear impact	—	—	—
safety_monitoring.pageNumber	Missing pages; uncertain format; unvalidated	—	CALC-SAF-002	—
soa_activity.activityId	V-ACT-001: Pattern mismatch	—	CALC-ACT-001	—
soa_activity.activityProcedure	Ambiguous procedure name	V-SOA-002: activityProcedure IS NULL or EMPTY	—	—
soa_activity.activityCategory	activityCategory IS NULL \| Ambiguous grouping, mixed categories in one section	—	—	—
soa_activity.categorySequence	N/A	—	CALC-SOA-CAT-SEQ	—
soa_activity.description	W-ACT-030: NULL description	—	—	—
soa_activity.visitHeaderText	Merged column headers, ambiguous visit labels	V-SOA-003: visitHeaderText IS NULL or EMPTY	—	—
soa_activity.visitScheduleText	Conditional text requires interpretation	V-SOA-004: visitScheduleText IS NULL or EMPTY	—	—
soa_activity.footnoteMarkersUsed	W-SOA-020: EMPTY but visitScheduleText contains superscripts \| Markers found but no corresponding footnote text	—	—	—
soa_activity.footnoteText	W-SOA-040: footnoteMarkersUsed NOT EMPTY but footnoteText IS NULL \| Marker present but no matching footnote text	—	—	—
soa_activity.assumptionNotes	Significant assumption made	—	—	—
soa_activity.pageNumber	V-ACT-100: NULL pageNumber	—	—	—
soa_activity.pageSection	W-ACT-101: NULL pageSection	—	—	—
soa_visit.visitId	V-VISIT-001: Pattern mismatch	—	CALC-VISIT-001	—
soa_visit.visitName	V-VISIT-002: NULL or EMPTY	—	—	—
soa_visit.visitOrder	V-VISIT-003: NULL or gap	—	CALC-VISIT-002	—
soa_visit.contextType	W-VISIT-010: Ambiguous context	—	—	✓
soa_visit.contextValue	W-VISIT-011: Ambiguous value	—	—	—
soa_visit.pageNumber	V-VISIT-100: NULL pageNumber	—	—	—
soa_visit.pageSection	W-VISIT-101: NULL pageSection	—	—	—
study_cells.cellId	V-CELL-001: cellId pattern mismatch	—	CALC-CELL-001 (cellId fallback)	—
study_cells.cellName	V-CELL-002: cellName NULL	—	—	—
study_cells.descriptionText	W-CELL-030: description too short	—	—	—
study_cells.purposeText	W-CELL-022: purpose invented	—	—	—
study_cells.armRefsText	W-CELL-010: armRefsText contains Arm_###	—	—	—
study_cells.epochRefsText	W-CELL-011: epochRefsText contains Epoch_###	—	—	—
study_cells.interventionRefsText	W-CELL-012: interventionRefsText contains Int_###	—	—	—
study_cells.activityRefsText	W-CELL-013: activityRefsText contains Act_###	—	—	—
study_cells.durationText	W-CELL-020: durationText normalized	—	—	—
study_cells.transitionRuleText	W-CELL-021: transition invented	—	—	—
study_cells.assumptionNotes	W-CELL-040: assumptionNotes missing when needed	—	—	—
study_cells.pageNumber	V-CELL-100: pageNumber missing	—	—	—
study_cells.pageSection	W-CELL-050: armRefsText AND epochRefsText both empty	—	—	—

Schema Validation Rules

5 rules ▼

blocking_rules

warning_rules

cross_field_rules

qc_categories

plausibility_checks

🗺 Schema Mapping schema_mapping_2_1.yaml 239 fields

Per-Field AI Instructions & Normalization

▼

Field	Cardinality	Normalization	CT Systems	AI Instructions (excerpt)
activities.activityCategory	—	M2_SINGLE_CT	CDISC_CT	Normalize. Classify activity type from SOA section headers. Map to controlled list (SAFETY,...
activities.activityId	Required	M1_PASSTHROUGH	—	Do NOT call TAL. Cross-reference with activities[]. Should match activityId. Empty → ERROR V-SOA-A-001
activities.activityLabel	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Extract or generate short label. Can be NULL
activities.activityName	Required	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve verbatim. Empty → WARNING W-ACT-001
activities.activityProcedure	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve verbatim from SOA row label. Should match activityName
activities.assumption	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Document assumptions. Free text. Can be NULL
activities.assumptionNotes	—	M1_PASSTHROUGH	—	Do NOT call TAL. Document extraction assumptions. Free text. Can be NULL
activities.categorySequence	—	M1_PASSTHROUGH	—	Do NOT call TAL. Parse row number within category section. Sequential integers. Non-integer →...
activities.collectionMethod	Required	M2_SINGLE_CT	CDISC_CT	Normalize. Map to controlled list if available (CENTRAL_LAB, LOCAL_LAB, INVESTIGATOR_REPORTED,...
activities.dataType	Optional	M2_SINGLE_CT	CDISC_CT	Classify data type. Map to controlled enum. Default NUMERIC for measurements
activities.description	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve any additional detail from SOA. Often NULL (detail in activities[] instead)
activities.footnoteMarkersUsed	—	M1_PASSTHROUGH	—	Do NOT call TAL. Extract superscript markers (1, 2, a, b, *, †). Link to footnoteText. Can be empty array
activities.footnoteText	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve footnote text verbatim. Map to footnoteMarkersUsed. Can be NULL if no footnotes
activities.frequency	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve frequency description. Can be NULL if varies by visit
activities.normalRange	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve range text. Can be NULL
activities.notes	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Free text. Can be NULL
activities.pageNumber	Required	M1_PASSTHROUGH	—	Do NOT call TAL. Extract SOA page. Usually same across all activities. Empty → WARNING W-SOA-A-001
activities.pageSection	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Extract section. Can be NULL
activities.specimenType	Optional	M2_SINGLE_CT	CDISC_CT	Apply ONLY if activity is specimen-based (labs/PK/biomarker). If non-specimen activity →...
activities.units	Optional	M5_UNIT_NORMALIZED	UCUM	Parse units. Normalize to UCUM. NULL for qualitative activities
activities.visitHeaderText	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve column headers as array. Supports SOA parsing validation
activities.visitScheduleText	—	M1_PASSTHROUGH	—	Do NOT call TAL. Extract cell markers from SOA matrix. Common patterns: X, ✓, •, numeric values,...
arms.armId	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Generate or preserve unique ID. Format: ARM_### or preserve sponsor format....
arms.armName	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve verbatim text from protocol. Normalize whitespace. Empty → WARNING W-ARM-001
arms.armType	SINGLE	M2_SINGLE_CT	CDISC_CT	Normalize. TAL: Sponsor CT → CDISC C170998 (EXPERIMENTAL, ACTIVE_COMPARATOR, PLACEBO_COMPARATOR,...
arms.description	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve detailed description. Can be NULL if only name provided
arms.interventions	SINGLE	M6_CROSS_VALIDATED	—	Do NOT call TAL. Extract intervention references. Cross-validate with interventions[]. Missing...
arms.notes	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve footnotes, amendments. Free text
arms.pageNumber	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Extract page numbers. Empty → WARNING W-ARM-005
arms.pageSection	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Extract section numbers/names. Can be NULL
arms.sampleSize	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Parse integer. Cross-validate sum equals targetEnrollment. Approximate →...
arms.sequenceCrossover	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL unless interventionModel=CROSSOVER. Parse sequence pattern (e.g., "A→B" or...
arms.treatmentDuration	SINGLE	M5_UNIT_NORMALIZED	UCUM	Parse duration. Normalize to UCUM. Can differ across arms in dose-ranging studies. NULL if not...
crossover_design.balancingFactor	SINGLE	M1_PASSTHROUGH	—	ONLY if CROSSOVER. Preserve text. Can be NULL
crossover_design.blockSize	SINGLE	M1_PASSTHROUGH	—	ONLY if CROSSOVER. Parse integer. NULL if not stated. Non-integer → ERROR V-XO-005
crossover_design.description	SINGLE	M1_PASSTHROUGH	—	ONLY if CROSSOVER. Preserve text. Can be NULL
crossover_design.expectedN	SINGLE	M1_PASSTHROUGH	—	ONLY if CROSSOVER. Parse integer. Sum across sequences should equal targetEnrollment. Mismatch →...
crossover_design.numberOfPeriods	SINGLE	M1_PASSTHROUGH	—	ONLY if CROSSOVER. Parse integer. Cross-validate with sequencePattern. Must be ≥2. Invalid →...
crossover_design.pageNumber	SINGLE	M1_PASSTHROUGH	—	ONLY if CROSSOVER. Extract page. Empty → WARNING W-XO-004
crossover_design.pageSection	SINGLE	M1_PASSTHROUGH	—	ONLY if CROSSOVER. Extract section. Can be NULL
crossover_design.periodInterventions	ARRAY	M6_CROSS_VALIDATED	—	ONLY if CROSSOVER. Extract intervention assignments per period. Length must equal...
crossover_design.randomizationRatio	ARRAY	M1_PASSTHROUGH	—	ONLY if CROSSOVER. Parse ratio (e.g., "1:1" for AB vs BA). Validate format. NULL if equal...
crossover_design.sequenceId	SINGLE	M1_PASSTHROUGH	—	ONLY if interventionModel=CROSSOVER. Generate or preserve ID. Format: SEQ_###. Empty → ERROR V-XO-001
crossover_design.sequenceName	SINGLE	M1_PASSTHROUGH	—	ONLY if CROSSOVER. Preserve verbatim. Empty → WARNING W-XO-001
crossover_design.sequencePattern	SINGLE	M1_PASSTHROUGH	—	ONLY if CROSSOVER. Normalize to standard pattern (A→B, B→A). Validate against numberOfPeriods....
crossover_design.washoutDuration	SINGLE	M5_UNIT_NORMALIZED	UCUM	ONLY if CROSSOVER. Parse duration. Normalize to UCUM. NULL if no washout (immediate crossover)....
eligibility_criteria.assumption	—	M1_PASSTHROUGH	—	Do NOT call TAL. Document parsing logic, ambiguities, component inference. Free text
eligibility_criteria.category	—	M2_SINGLE_CT	CDISC_CT	Normalize. Map to controlled enum (INCLUSION/EXCLUSION). Detect from section headers or...
eligibility_criteria.criterionId	—	M1_PASSTHROUGH	—	Do NOT call TAL. Duplicate of identifier field for backward compatibility. Same validation rules
eligibility_criteria.identifier	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve protocol ID if present (IC.1, EC.5). If missing → NULL + ERROR...
eligibility_criteria.negationFlag	—	M2_SINGLE_CT	CDISC_CT	Detect negation keywords ("no", "not", "absence of", "without"). Set TRUE if negated, FALSE...
eligibility_criteria.notes	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve footnotes, clarifications from protocol. Free text
eligibility_criteria.operator	—	M2_SINGLE_CT	CDISC_CT	Normalize operator symbols. Map to controlled list. Handle ranges (BETWEEN), lists (IN). NULL...
eligibility_criteria.pageNumber	—	M1_PASSTHROUGH	—	Do NOT call TAL. Extract page numbers. Support ranges. Empty → WARNING W-ELIG-001
eligibility_criteria.structured	—	M3_MULTI_ONTOLOGY	CDISC_CT SNOMED_CT RxNorm UCUM ICD	Parse into components: parameter, value, units, operator, timeframe, negation. CT mapping...
eligibility_criteria.text	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve complete text. Normalize whitespace. Handle sub-bullets (a,b,c). Empty...
eligibility_criteria.timeframe	—	M5_UNIT_NORMALIZED	UCUM	Parse timeframe phrases. Normalize durations to UCUM. Can be NULL if not time-dependent
eligibility_criteria.units	—	M5_UNIT_NORMALIZED	UCUM	Parse units from text. Normalize to UCUM. NULL if non-quantitative criterion
eligibility_criteria.value	—	M1_PASSTHROUGH	—	Do NOT call TAL. Parse value from text. Support numeric, ranges, lists, categorical. Store as...
encounters_and_visits.activitiesPerformed	—	M6_CROSS_VALIDATED	—	Do NOT call TAL. Extract activity references. Cross-validate with activities[]. May be derived...
encounters_and_visits.duration	—	M5_UNIT_NORMALIZED	UCUM	Parse duration. Normalize to UCUM (h, min). NULL if not stated. Approximate → WARNING W-ENC-003
encounters_and_visits.encId	—	M1_PASSTHROUGH	—	Do NOT call TAL. Generate or preserve unique ID. Format: ENC_### or V###. Empty → ERROR V-ENC-001
encounters_and_visits.encounterName	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve verbatim. Empty → WARNING W-ENC-001
encounters_and_visits.epochReference	—	M6_CROSS_VALIDATED	—	Do NOT call TAL. Extract epoch reference. Cross-validate with epochs[]. Missing epoch → WARNING W-ENC-002
encounters_and_visits.labsRequired	—	M2_SINGLE_CT	CDISC_CT	Detect lab requirements. Map to boolean. Keywords: "laboratory tests", "blood draw",...
encounters_and_visits.location	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve text. Can be NULL
encounters_and_visits.mode	—	M2_SINGLE_CT	CDISC_CT	Normalize. Map to controlled list if available. Default IN_PERSON. Unmapped → EXTENSION
encounters_and_visits.overnightStay	—	M2_SINGLE_CT	CDISC_CT	Detect overnight requirements. Keywords: "overnight", "24-hour observation", "admitted". Default FALSE
encounters_and_visits.pageNumber	—	M1_PASSTHROUGH	—	Do NOT call TAL. Extract page numbers. Empty → WARNING W-ENC-005
encounters_and_visits.pageSection	—	M1_PASSTHROUGH	—	Do NOT call TAL. Extract section. Can be NULL
encounters_and_visits.purpose	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve text. Can be NULL
encounters_and_visits.required	—	M2_SINGLE_CT	CDISC_CT	Detect required vs optional. Map to boolean. Keywords: "mandatory", "required", "optional"....
encounters_and_visits.studyDay	—	M1_PASSTHROUGH	—	Do NOT call TAL. Parse study day number. Ranges → store as string. Negative for screening....
encounters_and_visits.visitLabel	—	M1_PASSTHROUGH	—	Do NOT call TAL. Extract or generate short label. Normalize format. Can be NULL if not used
encounters_and_visits.windowMinus	—	M5_UNIT_NORMALIZED	UCUM	Parse window range. Normalize to days (d). NULL if no window. Non-numeric → ERROR V-ENC-003
encounters_and_visits.windowPlus	—	M5_UNIT_NORMALIZED	UCUM	Parse window range. Normalize to days (d). Can differ from windowMinus. NULL if no window
epochs.duration	SINGLE	M5_UNIT_NORMALIZED	UCUM	Parse duration. Normalize to UCUM. Event-driven epochs → EXTENSION. NULL if not specified →...
epochs.epochId	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Generate or preserve unique ID. Format: EPO_### or preserve sponsor format....
epochs.epochName	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve verbatim. Normalize whitespace. Empty → WARNING W-EPO-001
epochs.epochType	SINGLE	M2_SINGLE_CT	CDISC_CT	Normalize. TAL: Sponsor → CDISC C99079 (SCREENING, RUN_IN, TREATMENT, WASHOUT, FOLLOW_UP)....
epochs.notes	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Free text
epochs.pageNumber	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Extract page numbers. Empty → WARNING W-EPO-004
epochs.pageSection	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Extract section. Can be NULL
epochs.purpose	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve text. Can be NULL
epochs.sequenceInStudy	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Parse or infer sequence. Must be sequential starting at 1. Gaps → WARNING...
epochs.transitionRule	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Extract transition criteria. Can be NULL if sequential
interventions.assumptionNotes	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Document parsing assumptions. Free text. Can be NULL
interventions.crossoverPeriod	SINGLE	M1_PASSTHROUGH	—	ONLY if CROSSOVER. Parse period number or range. NULL for non-crossover
interventions.description	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve complete description. Can be NULL if name/label sufficient
interventions.dose	SINGLE	CONDITIONAL	—	Apply ONLY if type ∈ {DRUG, BIOLOGICAL}. Parse numeric/range and allow mg/kg, mg/m² patterns. If...
interventions.doseUnits	SINGLE	M5_UNIT_NORMALIZED	UCUM	Apply ONLY if dose present (or type ∈ {DRUG, BIOLOGICAL} and dose stated). Normalize to UCUM. If...
interventions.duration	SINGLE	M5_UNIT_NORMALIZED	UCUM	Parse duration. Normalize to UCUM. Event-driven → EXTENSION. NULL if matches arm/epoch duration
interventions.formulation	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve formulation description. Can be NULL
interventions.frequency	—	M1_PASSTHROUGH	—	Preserve verbatim dosing frequency. Do NOT normalize to UCUM.
interventions.indNumber	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve regulatory identifier. Format validation (IND ######). NULL for...
interventions.interventionId	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Generate or preserve unique ID. Format: INT_### or preserve sponsor format....
interventions.label	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve brand name or study code. Can differ from name. Can be NULL
interventions.manufacturer	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve verbatim. Can be NULL if not stated
interventions.name	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve verbatim name. Normalize whitespace. Empty → WARNING W-INT-001
interventions.pageNumber	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Extract page numbers. Empty → WARNING W-INT-002
interventions.pageSection	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Extract section. Can be NULL
interventions.route	SINGLE	M2_SINGLE_CT	CDISC_CT	Apply ONLY if type ∈ {DRUG, BIOLOGICAL}. If not → NOT_APPLICABLE (do not emit NULL). If...
interventions.type	SINGLE	M2_SINGLE_CT	CDISC_CT	Normalize. TAL order: Sponsor CT → CDISC/USDM allowed enum (if configured) exact/synonym → else...
objectives_and_endpoints.activityRefsText	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve narrative activity references. Can be NULL
objectives_and_endpoints.assessmentMethod	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve methodology description. Can be NULL
objectives_and_endpoints.assumptionNotes	—	M1_PASSTHROUGH	—	Do NOT call TAL. Document assumptions. Free text. Can be NULL
objectives_and_endpoints.description	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve complete text. Can be lengthy. Empty → WARNING W-OE-002
objectives_and_endpoints.encounterRefsText	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve narrative visit references. May be parsed to structured array later....
objectives_and_endpoints.level	—	M2_SINGLE_CT	CDISC_CT	Normalize. Sponsor CT → allowed enum (PRIMARY/SECONDARY/EXPLORATORY, etc.) if configured....
objectives_and_endpoints.measurement	—	M3_HIE_HIERARCHICAL	CDISC_CT SNOMED_CT RxNorm	Map only when a clear atomic measurement exists. TAL: LOINC (labs/vitals) → SNOMED (clinical...
objectives_and_endpoints.name	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve verbatim. Empty → WARNING W-OE-001
objectives_and_endpoints.oeId	—	M1_PASSTHROUGH	—	Do NOT call TAL. Generate or preserve unique ID. Format: OBJ_### or EP_###. Empty → ERROR V-OE-002
objectives_and_endpoints.pageNumber	—	M1_PASSTHROUGH	—	Do NOT call TAL. Extract page numbers. Empty → WARNING W-OE-003
objectives_and_endpoints.purpose	—	M2_SINGLE_CT	CDISC_CT	Normalize. Map to controlled list if available (EFFICACY, SAFETY, PK, PD, BIOMARKER). Unmapped →...
objectives_and_endpoints.recordType	—	M2_SINGLE_CT	CDISC_CT	Normalize. Map to controlled enum (OBJECTIVE, ENDPOINT). Detect from section headers. Invalid →...
objectives_and_endpoints.statisticalMethod	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve statistical approach. Can be NULL
objectives_and_endpoints.timepoint	—	M5_UNIT_NORMALIZED	UCUM	Parse timepoint. Normalize durations to UCUM. Support ranges, milestones. Can be NULL if in...
objectives_and_endpoints.units	—	M5_UNIT_NORMALIZED	UCUM	Parse units. Normalize to UCUM. NULL for non-quantitative endpoints (e.g., event occurrence)
objectives_and_endpoints.windowHigh	—	M5_UNIT_NORMALIZED	UCUM	Parse window. Normalize to UCUM (days). Can differ from windowLow. NULL if no window
objectives_and_endpoints.windowLow	—	M5_UNIT_NORMALIZED	UCUM	Parse window. Normalize to UCUM (days). NULL if no window specified
population_and_cohorts.actualN	—	M1_PASSTHROUGH	—	Do NOT call TAL. Parse integer. Only present in amendment documents. Original protocol → NULL....
population_and_cohorts.assumption	—	M1_PASSTHROUGH	—	Do NOT call TAL. Document extraction logic, ambiguities, inferences. Free text. Can be NULL
population_and_cohorts.criteriaReferenceMode	—	M2_SINGLE_CT	CDISC_CT	Determine reference mode. If protocol uses explicit ID linking → EXPLICIT_IDS. If states "all...
population_and_cohorts.description	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve text verbatim. Trim whitespace. Can be NULL if not stated
population_and_cohorts.exclusionCriteriaIDs	—	M6_CROSS_VALIDATED	—	Do NOT call TAL. Do NOT infer IDs. Use only IDs present in Design Agent output...
population_and_cohorts.inclusionCriteriaIDs	—	M6_CROSS_VALIDATED	—	Do NOT call TAL. Do NOT infer IDs. Use only IDs present in Design Agent output...
population_and_cohorts.linkedArmIDs	—	M6_CROSS_VALIDATED	—	Do NOT call TAL. Extract arm references. Cross-validate with studyArms[]. ITT/Safety populations...
population_and_cohorts.notes	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve any footnotes or special notes from protocol. Free text. Can be NULL
population_and_cohorts.pageNumber	—	M1_PASSTHROUGH	—	Do NOT call TAL. Extract page numbers or section references. Support ranges. Empty → WARNING W-POP-007
population_and_cohorts.plannedN	—	M1_PASSTHROUGH	—	Do NOT call TAL. Parse integer. If same as targetEnrollment, note derivation. Approximate values...
population_and_cohorts.plannedN_type	—	M2_SINGLE_CT	CDISC_CT	Normalize to TOTAL, PER_ARM, or PER_COHORT based on the scope stated in the protocol. Use TOTAL...
population_and_cohorts.plannednType	—	M2_SINGLE_CT	CDISC_CT	Normalize enrollment qualifier: EXACT, APPROXIMATE, RANGE, UP_TO, AT_LEAST.
population_and_cohorts.populationCategory	—	M2_SINGLE_CT	CDISC_CT	Normalize cohort-type labels only: DOSE_ESCALATION, DOSE_EXPANSION, SENTINEL, ENRICHMENT,...
population_and_cohorts.populationId	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve extracted ID only. Schema Agent must NOT fabricate protocol IDs. If...
population_and_cohorts.populationName	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve verbatim text. Normalize whitespace. Empty → WARNING W-POP-001
protocol_version.amendmentNumber	—	M1_PASSTHROUGH	—	Do NOT call TAL. Parse integer if explicitly present. Original protocol → 0 or NULL per your...
protocol_version.approvalDate	—	M1_PASSTHROUGH	—	Do NOT call TAL. Extract from signature page only. Parse to ISO 8601. If no signature page →...
protocol_version.effectiveDate	—	M1_PASSTHROUGH	—	Do NOT call TAL. Parse date formats. Output ISO (YYYY-MM-DD). If unparseable → NULL + WARNING W-PV-010.
protocol_version.evidencePageNumbers	—	M1_PASSTHROUGH	—	Do NOT call TAL. Extract page numbers where version info found. Support ranges. Normalize format...
protocol_version.isLatestByOrdering	—	M1_PASSTHROUGH	—	Do NOT call TAL. Computed by Schema Agent using precedence: (1) Explicit marker, (2)...
protocol_version.lifecycleStatus	—	M1_PASSTHROUGH	CDISC_CT	Do NOT call TAL. Computed deterministically: isLatestByOrdering=TRUE → CURRENT; FALSE →...
protocol_version.notes	—	M1_PASSTHROUGH	—	Free text. Preserve verbatim.
protocol_version.orderingMethod	—	M1_PASSTHROUGH	CDISC_CT	Do NOT call TAL. Computed by Schema Agent indicating which method determined isLatestByOrdering....
protocol_version.reasonForAmendment	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve text verbatim. Missing reason when amendmentNumber>0 → WARNING.
protocol_version.regulatoryStatus	—	M2_SINGLE_CT	CDISC_CT	Normalize. Map to controlled enum. EXTRACTED only—no inference. Require explicit statement....
protocol_version.sectionsModified	—	M1_PASSTHROUGH	—	Do NOT call TAL. Extract list of section numbers or names from amendment summary. Normalize...
protocol_version.subjectsEnrolled	—	M1_PASSTHROUGH	—	Do NOT call TAL. Parse integer from amendment context. NULL if not stated → WARNING W-PV-012....
protocol_version.substantialChange	—	M2_SINGLE_CT	CDISC_CT	Normalize to YES/NO/UNKNOWN. Map to CDISC CT if available.
protocol_version.versionId	—	M1_PASSTHROUGH	—	Do NOT generate or expand this value. Preserve the short visible version string exactly as...
protocol_version.versionIdentifier	—	M1_PASSTHROUGH	—	Lock container naming to protocolVersions[]. Preserve extracted value only. No renaming or...
protocol_version.versionNotes	—	M1_PASSTHROUGH	—	Do NOT call TAL. Agent-generated notes documenting extraction decisions, assumptions, or...
protocol_version.versionNumber	—	M1_PASSTHROUGH	—	Preserve verbatim version number. Validate pattern.
protocol_version.versionNumberRaw	—	M1_PASSTHROUGH	—	Store raw/helper fields ONLY in extensionAttributes. Do NOT duplicate in USDM core. Parse...
safety_monitoring.action	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve action description. Can be NULL
safety_monitoring.assumptionNotes	—	M1_PASSTHROUGH	—	Do NOT infer from “standard practice.” Only document assumptions that are explicitly warranted...
safety_monitoring.description	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve complete description. Can be NULL
safety_monitoring.encounterId	—	M6_CROSS_VALIDATED	—	Do NOT call TAL. Extract encounter reference. Cross-validate with encounters[]. Can be array for...
safety_monitoring.endpointParameter	—	M3_HIE_HIERARCHICAL	CDISC_CT MedDRA SNOMED_CT RxNorm	Normalize. TAL: MedDRA for AEs, LOINC for labs, SNOMED for clinical findings. Store code+display...
safety_monitoring.escalationCriteria	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve criteria text. Can be NULL
safety_monitoring.gradingScale	—	M2_SINGLE_CT	CDISC_CT	Normalize. Map to controlled list (CTCAE, WHO, CUSTOM). Version important. Unmapped → EXTENSION
safety_monitoring.monitoringId	—	M1_PASSTHROUGH	—	Do NOT call TAL. Generate unique ID. Format: SM_###. Empty → ERROR V-SM-001
safety_monitoring.pageNumber	—	M1_PASSTHROUGH	—	Do NOT call TAL. Extract page numbers. Empty → WARNING W-SM-001
safety_monitoring.reportingWindow	—	M5_UNIT_NORMALIZED	UCUM	Normalize duration units when explicit. If “business days” present, keep...
safety_monitoring.schedule	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve schedule description. Can be NULL
safety_monitoring.type	—	M2_SINGLE_CT	CDISC_CT	Normalize. Map to controlled list (AE_MONITORING, LAB_MONITORING, DOSE_MODIFICATION,...
soa_activity.activityCategory	—	M2_SINGLE_CT	CDISC_CT	Normalize. Classify activity type from SOA section headers. Map to controlled list.
soa_activity.activityId	—	M1_PASSTHROUGH	—	Do NOT call TAL. Cross-reference with activities[]. Empty → ERROR V-SOA-A-001
soa_activity.activityProcedure	—	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve verbatim from SOA row label.
soa_activity.assumptionNotes	—	M1_PASSTHROUGH	—	Document extraction assumptions.
soa_activity.categorySequence	—	M1_PASSTHROUGH	—	System-generated. Do NOT extract.
soa_activity.description	—	M1_PASSTHROUGH	—	Free text description. Preserve verbatim.
soa_activity.footnoteMarkersUsed	—	M1_PASSTHROUGH	—	Extract superscript markers from SOA cells. Comma-separate.
soa_activity.footnoteText	—	M1_PASSTHROUGH	—	Extract footnote text linked to markers. Preserve verbatim.
soa_activity.pageNumber	—	M1_PASSTHROUGH	—	Page number where SOA table was found.
soa_activity.pageSection	—	M1_PASSTHROUGH	—	Section reference for SOA table.
soa_activity.visitHeaderText	—	M1_PASSTHROUGH	—	Preserve verbatim column header text from SOA table.
soa_activity.visitScheduleText	—	M1_PASSTHROUGH	—	Preserve cell content (X, check, text). Do NOT interpret.
soa_visit.contextType	Optional	M2_SINGLE_CT	CDISC_CT	Normalize. Classify visit type from SOA. Default SCHEDULED. Detect keywords ("unscheduled",...
soa_visit.contextValue	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Parse timing from SOA header. Support various formats (Day X, Week X, C#D#)....
soa_visit.pageNumber	Required	M1_PASSTHROUGH	—	Do NOT call TAL. Extract SOA table page. All visits typically share same page. Empty → WARNING...
soa_visit.pageSection	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Extract section. Can be NULL
soa_visit.visitId	Required	M1_PASSTHROUGH	—	Do NOT call TAL. Cross-reference with encounters[]. Should match encId. Empty → ERROR V-SOA-V-001
soa_visit.visitName	Required	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve verbatim from SOA table. Should match encounterName
soa_visit.visitOrder	Required	M1_PASSTHROUGH	—	Do NOT call TAL. Parse column order from SOA. Must be sequential. Non-integer → ERROR V-SOA-V-002
study_cells.activityRefsText	Optional	M6_CROSS_VALIDATED	—	Do NOT call TAL. Extract activity references. Cross-validate with activities[]. May be derived...
study_cells.armRefsText	Optional	M6_CROSS_VALIDATED	—	Do NOT call TAL. Extract arm references. Cross-validate with studyArms[]. Can be array for...
study_cells.assumptionNotes	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Document cell derivation logic. Free text. Can be NULL
study_cells.cellId	Required	M1_PASSTHROUGH	—	Do NOT call TAL. Generate unique ID combining arm+epoch. Format: CELL_###. Empty → ERROR V-CELL-001
study_cells.cellName	Required	M1_PASSTHROUGH	—	Do NOT call TAL. Generate or preserve descriptive name. Can derive from arm+epoch names
study_cells.descriptionText	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve description. Can be NULL
study_cells.durationText	Optional	M5_UNIT_NORMALIZED	UCUM	Parse duration. Normalize to UCUM. Often inherited from epoch. NULL if epoch defines duration
study_cells.epochRefsText	Optional	M6_CROSS_VALIDATED	—	Do NOT call TAL. Extract epoch reference. Cross-validate with epochs[]. Missing epoch → WARNING...
study_cells.interventionRefsText	Optional	M6_CROSS_VALIDATED	—	Do NOT call TAL. Extract intervention references. Cross-validate with interventions[]. Can be...
study_cells.pageNumber	Required	M1_PASSTHROUGH	—	Do NOT call TAL. Extract page numbers. Empty → WARNING W-CELL-005
study_cells.pageSection	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Extract section. Can be NULL
study_cells.purposeText	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve purpose description. Can be NULL
study_cells.transitionRuleText	Optional	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve transition criteria. Often inherited from epoch. Can be NULL
study_design_and_definition.allocation	SINGLE	M2_SINGLE_CT	CDISC_CT	Only applicable if studyType=INTERVENTIONAL. Normalize then TAL: Sponsor→CDISC exact/synonym. If...
study_design_and_definition.allocationRatio	ARRAY	M1_PASSTHROUGH	—	Do NOT call TAL. Parse "1:1", "2:1:1". Validate numeric. If conflicts with numberOfArms → QC WARNING
study_design_and_definition.blindingSchema	SINGLE	M2_SINGLE_CT	CDISC_CT	Normalize. Use CDISC blinding codelist. If multi-party blinding described, keep structured...
study_design_and_definition.controlType	SINGLE	M2_SINGLE_CT	CDISC_CT	Normalize. Map to allowed control types (placebo/active/no control). If unclear, keep extension...
study_design_and_definition.dataMonitoringCommittee	SINGLE	M2_SINGLE_CT	—	Normalize. Map to YES/NO/NOT_APPLICABLE. Look for DMC, DSMB, IDMC references.
study_design_and_definition.doseEscalationSchema	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Extract dose escalation/titration schedule. Preserve verbatim. Can be NULL
study_design_and_definition.followUpPeriod	SINGLE	M5_UNIT_NORMALIZED	UCUM	Normalize; if "long-term follow-up" without number → EXTENSION + WARNING
study_design_and_definition.id	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Regex validate known patterns (NCT/EudraCT/IND/sponsor). Trim only. If invalid...
study_design_and_definition.hyperglycemiaRescueCriteria	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Extract quantitative rescue trigger criteria (FPG/HbA1c thresholds). Preserve...
study_design_and_definition.interimAnalysis	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Extract pre-specified interim analysis plan including timing, purpose, decision...
study_design_and_definition.interventionModel	SINGLE	M2_SINGLE_CT	CDISC_CT	Normalize then TAL: Sponsor→CDISC exact/synonym. If crossover keywords exist but mapped PARALLEL...
study_design_and_definition.interventionType	SINGLE	M2_SINGLE_CT	CDISC_CT	Normalize. Sponsor CT first, then public CT if available. If not defined, EXTENSION_ROUTED
study_design_and_definition.maskingRoles	ARRAY	M2_SINGLE_CT	—	Map blinded parties to allowed values (PARTICIPANT, INVESTIGATOR, ASSESSOR, CARE_PROVIDER,...
study_design_and_definition.name	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Trim whitespace. Preserve punctuation/case. Placeholder ("TBD") → WARNING...
study_design_and_definition.numberOfArms	SINGLE	M6_CROSS_VALIDATED	—	Do NOT call TAL. Validate integer >0. After arms extraction, cross-validate count equals...
study_design_and_definition.observationalModel	SINGLE	CONDITIONAL	CDISC_CT	If studyType != OBSERVATIONAL → NOT_APPLICABLE with rationale (field skipped). If OBSERVATIONAL:...
study_design_and_definition.participantDuration	SINGLE	M5_UNIT_NORMALIZED	UCUM	Parse per-subject duration; if multiple components, store structured + extension notes
study_design_and_definition.phaseCode	SINGLE	M2_SINGLE_CT	CDISC_CT	Normalize. Detect phase patterns (I,1,1b,2a, I/II, etc.). TAL: Sponsor → CDISC C66737...
study_design_and_definition.populationAgeRange	SINGLE	M5_UNIT_NORMALIZED	UCUM	Extract min/max and units. Normalize to UCUM without unit conversion math unless UNIT-CONV rule...
study_design_and_definition.primaryEstimand	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Extract full estimand per ICH E9(R1) framework. Include treatment condition,...
study_design_and_definition.primaryCompletionType	SINGLE	M2_SINGLE_CT	CDISC_CT	Normalize. If CDISC/USDM codelist exists in implementation, map exact/synonym. Else PASSTHROUGH...
study_design_and_definition.protocolDate	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Parse dates (MM/DD/YYYY, DD-MMM-YYYY). Output ISO date. If invalid → ERROR...
study_design_and_definition.protocolVersion	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Validate version patterns (v#, x.y, Amendment #). Normalize "Version 3.0" →...
study_design_and_definition.randomizationMethod	SINGLE	M4_SPONSOR_MAPPED	CDISC_CT	Normalize. Sponsor CT dictionary first (IRT, IVRS, permuted block). If no CT available,...
study_design_and_definition.rationale	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Preserve text. Trim only. Empty rationale → WARNING
study_design_and_definition.rescueTherapy	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Extract rescue medications/procedures and trigger criteria. Preserve verbatim....
study_design_and_definition.regulatoryIdentifier	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Validate common formats (IND ######, CTA). Preserve original
study_design_and_definition.screeningPeriod	SINGLE	M5_UNIT_NORMALIZED	UCUM	Parse "screening up to 28 days". If range, store max and note
study_design_and_definition.screeningTarget	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Parse integer. Distinct from targetEnrollment (enrolled). Non-numeric → ERROR
study_design_and_definition.sponsor	SINGLE	M4_SPONSOR_MAPPED	CDISC_CT	Normalize org strings. Lookup Sponsor CT dictionary for canonical sponsor name + IDs. If not...
study_design_and_definition.stratificationFactors	ARRAY	M1_PASSTHROUGH	—	Do NOT call TAL unless sponsor CT provided for factors. Preserve list items. Normalize whitespace
study_design_and_definition.studyArms	ARRAY	M6_CROSS_VALIDATED	CDISC_CT	Do NOT map here unless armType present. Validate array structure; ensure arm.sequence/order....
study_design_and_definition.studyDuration	SINGLE	M5_UNIT_NORMALIZED	UCUM	Parse duration phrases. Normalize to structured {value, unit UCUM}. Preserve original text....
study_design_and_definition.studyPhase	SINGLE	DERIVED	CDISC_CT	Do NOT call TAL. Derive from phaseCode mapping. If combined phase, keep combined label. If phase...
study_design_and_definition.studyType	SINGLE	M2_SINGLE_CT	CDISC_CT	Do NOT call TAL. Extract or derive study type (INTERVENTIONAL/OBSERVATIONAL/EXPANDED_ACCESS)....
study_design_and_definition.studyTypeMasking	SINGLE	M2_SINGLE_CT	CDISC_CT	Normalize. TAL order Sponsor→CDISC C66735 exact/synonym→NCIt. If fuzzy <0.85 or ambiguous term →...
study_design_and_definition.targetEnrollment	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Parse integer. If range, store min/max or extension. Non-numeric → ERROR
study_design_and_definition.therapeuticAreas	SINGLE	M3_HIE_HIERARCHICAL	MedDRA SNOMED_CT ICD	Normalize disease area text. TAL order: Sponsor CT → MedDRA PT exact/synonym → SNOMED → ICD....
study_design_and_definition.treatmentPeriod	SINGLE	M5_UNIT_NORMALIZED	UCUM	Parse treatment duration; if cycle-based, store cycles + cycle length
study_design_and_definition.trialRegistryIdentifier	SINGLE	M1_PASSTHROUGH	—	Regex validate NCT/EudraCT/ISRCTN. Invalid → ERROR
study_design_and_definition.trialType	SINGLE	M2_SINGLE_CT	CDISC_CT	Normalize; TAL order Sponsor→CDISC. If sponsor-specific intent → SPONSOR_OVERRIDE required
study_design_and_definition.usdmVersion	SINGLE	M1_PASSTHROUGH	—	Do NOT call TAL. Set from system configuration (e.g., "USDM v4.0"). Lock field (non-editable)

🚧 Gate Rules gate_rules_3_0.yaml

Gate Summary Table

▼

Gate ID	Trigger Field	Condition	Severity	Gated Count	Standard Ref
G01_non_interventional	study_design_and_definition.studyType	value != 'INTERVENTIONAL'	HARD	61 fields	ICH E8(R1) §2; ICH M11 §4; SPIRIT 2013 Item 7
G07_interventional_no_obs_model	study_design_and_definition.studyType	value == 'INTERVENTIONAL'	HARD	1 fields	ICH M11 §4; STROBE
G10_expanded_access	study_design_and_definition.studyType	value == 'EXPANDED_ACCESS'	SOFT	19 fields	ICH M11 §4; FDA 21 CFR 312.310; EU Regulation Article 83
G05_single_group	study_design_and_definition.interventionModel	value == 'SINGLE_GROUP'	SOFT	7 fields	ICH E8(R1) §4.3; ICH M11 §4.2; ICH E10
G03_not_crossover	study_design_and_definition.interventionModel	value != 'CROSSOVER'	HARD	14 fields	ICH E8(R1) §4.3; ICH M11 §4.2; ICH E9 §2.3.4
G02_non_randomized	study_design_and_definition.allocation	value != 'RANDOMIZED'	HARD	6 fields	ICH E8(R1) §4.4; ICH M11 §4.5; SPIRIT 2013 Item 16a; ICH E9 §2.3
G04_open_label	study_design_and_definition.blindingSchema	value == 'NONE'	SOFT	1 fields	ICH M11 §4.4; SPIRIT 2013 Item 11b
G06_uncontrolled	study_design_and_definition.controlType	value == 'UNCONTROLLED'	SOFT	2 fields	ICH E10 §2.1; ICH M11 §4.2
G08_not_early_phase	study_design_and_definition.phaseCode	value not in ('EARLY_PHASE1', 'PHASE1', 'PHASE1/PHASE2')	SOFT	1 fields	ICH E8(R1) §4.1; ICH M11 §4.1; FDA Phase 1 Oncology Guidance
G09_no_amendment	protocol_version.amendmentNumber	value is None or value == '' or value == '0'	HARD	4 fields	ICH M11 §1; SPIRIT 2013 Item 25; ICH E6(R2) §4.5.2

G01_non_interventional HARD study_design_and_definition.studyType 61 gated ▼

Trigger Field

study_design_and_definition.studyType

Condition

value != 'INTERVENTIONAL'

Validator Action

warn

Standard Ref

ICH E8(R1) §2; ICH M11 §4; SPIRIT 2013 Item 7

Observational and expanded-access studies do not assign participants to interventions, so fields describing randomisation, arm structure, blinding, crossover design, and interventional control are structurally inapplicable.

Gated Fields (61)

study_design_and_definition.allocation study_design_and_definition.allocationRatio study_design_and_definition.randomizationMethod study_design_and_definition.stratificationFactors study_design_and_definition.blindingSchema study_design_and_definition.studyTypeMasking study_design_and_definition.interventionModel study_design_and_definition.interventionType study_design_and_definition.controlType study_design_and_definition.numberOfArms study_design_and_definition.studyArms arms.armName arms.armType arms.description arms.interventions arms.sampleSize arms.treatmentDuration arms.sequenceCrossover arms.notes arms.pageNumber arms.pageSection crossover_design.sequenceName crossover_design.sequencePattern crossover_design.description crossover_design.numberOfPeriods crossover_design.periodInterventions crossover_design.washoutDuration crossover_design.randomizationRatio crossover_design.blockSize crossover_design.balancingFactor crossover_design.expectedN crossover_design.pageNumber crossover_design.pageSection interventions.name interventions.label interventions.type interventions.description interventions.dose interventions.doseUnits interventions.frequency interventions.route interventions.formulation interventions.duration interventions.crossoverPeriod interventions.manufacturer interventions.indNumber interventions.assumptionNotes interventions.pageNumber interventions.pageSection study_cells.cellName study_cells.descriptionText study_cells.purposeText study_cells.armRefsText study_cells.epochRefsText study_cells.interventionRefsText study_cells.activityRefsText study_cells.durationText study_cells.transitionRuleText study_cells.assumptionNotes study_cells.pageNumber study_cells.pageSection

G07_interventional_no_obs_model HARD study_design_and_definition.studyType 1 gated ▼

Trigger Field

study_design_and_definition.studyType

Condition

value == 'INTERVENTIONAL'

Validator Action

drop

Standard Ref

ICH M11 §4; STROBE

Observational model (cohort, case-control, cross-sectional) is only applicable to observational studies, not interventional ones.

Gated Fields (1)

study_design_and_definition.observationalModel

G10_expanded_access SOFT study_design_and_definition.studyType 19 gated ▼

Trigger Field

study_design_and_definition.studyType

Condition

value == 'EXPANDED_ACCESS'

Validator Action

warn

Standard Ref

ICH M11 §4; FDA 21 CFR 312.310; EU Regulation Article 83

Expanded access programs typically lack formal study design elements: no randomisation, no blinding, no endpoints analysis, no formal SoA. Safety monitoring and eligibility remain relevant.

Gated Fields (19)

objectives_and_endpoints.statisticalMethod objectives_and_endpoints.windowLow objectives_and_endpoints.windowHigh soa_activity.visitHeaderText soa_activity.visitScheduleText soa_activity.footnoteMarkersUsed soa_activity.footnoteText study_cells.cellName study_cells.descriptionText study_cells.purposeText study_cells.armRefsText study_cells.epochRefsText study_cells.interventionRefsText study_cells.activityRefsText study_cells.durationText study_cells.transitionRuleText study_cells.assumptionNotes study_cells.pageNumber study_cells.pageSection

G05_single_group SOFT study_design_and_definition.interventionModel 7 gated ▼

Trigger Field

study_design_and_definition.interventionModel

Condition

value == 'SINGLE_GROUP'

Validator Action

warn

Standard Ref

ICH E8(R1) §4.3; ICH M11 §4.2; ICH E10

A single-group (single-arm) study has no control arm, so control type, allocation, allocation ratio, and stratification are inapplicable. Number of arms is deterministically 1. Single-arm studies can still use assessor or role-level blinding, so masking fields should remain warning-only.

Gated Fields (7)

study_design_and_definition.controlType study_design_and_definition.allocation study_design_and_definition.allocationRatio study_design_and_definition.randomizationMethod study_design_and_definition.stratificationFactors study_design_and_definition.blindingSchema study_design_and_definition.studyTypeMasking

G03_not_crossover HARD study_design_and_definition.interventionModel 14 gated ▼

Trigger Field

study_design_and_definition.interventionModel

Condition

value != 'CROSSOVER'

Validator Action

warn

Standard Ref

ICH E8(R1) §4.3; ICH M11 §4.2; ICH E9 §2.3.4

Crossover sequences, washout periods, period-intervention mappings, and within-subject carryover considerations only apply to crossover designs.

Gated Fields (14)

crossover_design.sequenceName crossover_design.sequencePattern crossover_design.description crossover_design.numberOfPeriods crossover_design.periodInterventions crossover_design.washoutDuration crossover_design.randomizationRatio crossover_design.blockSize crossover_design.balancingFactor crossover_design.expectedN crossover_design.pageNumber crossover_design.pageSection arms.sequenceCrossover interventions.crossoverPeriod

G02_non_randomized HARD study_design_and_definition.allocation 6 gated ▼

Trigger Field

study_design_and_definition.allocation

Condition

value != 'RANDOMIZED'

Validator Action

warn

Standard Ref

ICH E8(R1) §4.4; ICH M11 §4.5; SPIRIT 2013 Item 16a; ICH E9 §2.3

Without randomisation there is no allocation ratio, no randomisation method, no stratification factors, and no block-size or balancing-factor logic.

Gated Fields (6)

study_design_and_definition.allocationRatio study_design_and_definition.randomizationMethod study_design_and_definition.stratificationFactors crossover_design.randomizationRatio crossover_design.blockSize crossover_design.balancingFactor

G04_open_label SOFT study_design_and_definition.blindingSchema 1 gated ▼

Trigger Field

study_design_and_definition.blindingSchema

Condition

value == 'NONE'

Validator Action

warn

Standard Ref

ICH M11 §4.4; SPIRIT 2013 Item 11b

An open-label study has no blinding procedures; the narrative description of masking is therefore inapplicable.

Gated Fields (1)

study_design_and_definition.studyTypeMasking

G06_uncontrolled SOFT study_design_and_definition.controlType 2 gated ▼

Trigger Field

study_design_and_definition.controlType

Condition

value == 'UNCONTROLLED'

Validator Action

warn

Standard Ref

ICH E10 §2.1; ICH M11 §4.2

An uncontrolled study has no comparator arm. Blinding schema may still exist (e.g. dose-blinding within a single active arm), so this is SOFT.

Gated Fields (2)

study_design_and_definition.blindingSchema study_design_and_definition.studyTypeMasking

G08_not_early_phase SOFT study_design_and_definition.phaseCode 1 gated ▼

Trigger Field

study_design_and_definition.phaseCode

Condition

value not in ('EARLY_PHASE1', 'PHASE1', 'PHASE1/PHASE2')

Validator Action

warn

Standard Ref

ICH E8(R1) §4.1; ICH M11 §4.1; FDA Phase 1 Oncology Guidance

Dose-limiting toxicity definitions and dose-escalation methods (3+3, mCRM, BOIN) are relevant only in early-phase dose-finding studies. Phase 2b and later studies do not typically employ formal dose escalation.

Gated Fields (1)

safety_monitoring.escalationCriteria

G09_no_amendment HARD protocol_version.amendmentNumber 4 gated ▼

Trigger Field

protocol_version.amendmentNumber

Condition

value is None or value == '' or value == '0'

Validator Action

drop

Standard Ref

ICH M11 §1; SPIRIT 2013 Item 25; ICH E6(R2) §4.5.2

If the protocol has not been amended, amendment rationale, sections modified, substantial change classification, and subjects enrolled at time of amendment are all inapplicable.

Gated Fields (4)

protocol_version.reasonForAmendment protocol_version.sectionsModified protocol_version.substantialChange protocol_version.subjectsEnrolled

🔗 USDM Path Registry usdm_path_registry_2_0.yaml 239 paths USDM 4.0

JSONPath Mappings

▼

Field	USDM JSON Path	Instance Type
study_design_and_definition.id	$.studyDesign.studyId	SINGLE
study_design_and_definition.name	$.studyDesign.studyTitle	SINGLE
study_design_and_definition.protocolVersion	$.studyDesign.protocolVersion	SINGLE
study_design_and_definition.protocolDate	$.studyDesign.protocolDate	SINGLE
study_design_and_definition.sponsor	$.study.organizations[?(@.typeCode=='SPONSOR')].name	SINGLE
study_design_and_definition.regulatoryIdentifier	$.study.studyIdentifiers[?(@.typeCode=='REGULATORY')].studyIdentifier	SINGLE
study_design_and_definition.trialRegistryIdentifier	$.study.studyIdentifiers[?(@.typeCode=='REGISTRY')].studyIdentifier	SINGLE
study_design_and_definition.usdmVersion	$.usdmVersion	SINGLE
study_design_and_definition.rationale	$.studyDesign.rationale	SINGLE
study_design_and_definition.studyType	$.studyDesign.studyType.code	SINGLE
study_design_and_definition.trialType	$.studyDesign.trialType[*].code	SINGLE
study_design_and_definition.phaseCode	$.studyDesign.trialIntentType[*].code	SINGLE
study_design_and_definition.studyPhase	$.studyDesign.studyPhase.standardCode.decode	SINGLE
study_design_and_definition.interventionModel	$.studyDesign.interventionModel.code	SINGLE
study_design_and_definition.interventionType	$.studyDesign.interventions[*].typeCode	SINGLE
study_design_and_definition.allocation	$.studyDesign.allocation.code	SINGLE
study_design_and_definition.allocationRatio	$.studyDesign.ratioAllocation	SINGLE
study_design_and_definition.randomizationMethod	$.studyDesign.randomizationMethod	SINGLE
study_design_and_definition.stratificationFactors	$.studyDesign.stratificationFactors	LIST
study_design_and_definition.blindingSchema	$.studyDesign.masking.level.code	SINGLE
study_design_and_definition.studyTypeMasking	$.studyDesign.masking.description	SINGLE
study_design_and_definition.controlType	$.studyDesign.studyArms[?(@.typeCode=='PLACEBO_COMPARATOR' \|\| @.typeCode=='ACTIVE_COMPARATOR')].typeCode	SINGLE
study_design_and_definition.numberOfArms	$.studyDesign.studyArms.length()	SINGLE
study_design_and_definition.studyArms	$.studyDesign.studyArms	LIST
study_design_and_definition.observationalModel	$.studyDesign.observationalModel.code	SINGLE
study_design_and_definition.targetEnrollment	$.studyDesign.plannedSubjectsNumber	SINGLE
study_design_and_definition.populationAgeRange	$.studyDesign.population.plannedAge	SINGLE
study_design_and_definition.therapeuticAreas	$.studyDesign.therapeuticAreas	LIST
study_design_and_definition.studyDuration	$.studyDesign.studyDuration	SINGLE
study_design_and_definition.participantDuration	$.studyDesign.population.plannedDuration	SINGLE
study_design_and_definition.screeningPeriod	$.studyDesign.studyEpochs[?(@.typeCode=='SCREENING')].duration	SINGLE
study_design_and_definition.treatmentPeriod	$.studyDesign.studyEpochs[?(@.typeCode=='TREATMENT')].duration	SINGLE
study_design_and_definition.followUpPeriod	$.studyDesign.studyEpochs[?(@.typeCode=='FOLLOW_UP')].duration	SINGLE
study_design_and_definition.primaryCompletionType	$.studyDesign.primaryCompletionType	SINGLE
study_design_and_definition.dataMonitoringCommittee	$.studyDesign.dataMonitoringCommittee	SINGLE
study_design_and_definition.doseEscalationSchema	$.studyDesign.doseEscalation	SINGLE
study_design_and_definition.hyperglycemiaRescueCriteria	$.studyDesign.rescueCriteria	SINGLE
study_design_and_definition.interimAnalysis	$.studyDesign.interimAnalysis	SINGLE
study_design_and_definition.maskingRoles	$.studyDesign.maskingRole	LIST
study_design_and_definition.primaryEstimand	$.studyDesign.estimand	SINGLE
study_design_and_definition.rescueTherapy	$.studyDesign.rescueTherapy	SINGLE
study_design_and_definition.screeningTarget	$.studyDesign.screeningTarget	SINGLE
arms.armId	$.studyDesign.studyArms[*].id	MULTI
arms.armName	$.studyDesign.studyArms[*].name	MULTI
arms.armType	$.studyDesign.studyArms[*].typeCode	MULTI
arms.description	$.studyDesign.studyArms[*].description	MULTI
arms.interventions	$.studyDesign.studyArms[*].studyInterventions	MULTI
arms.sampleSize	$.studyDesign.studyArms[*].plannedSubjectsNumber	MULTI
arms.treatmentDuration	$.studyDesign.studyArms[*].duration	MULTI
arms.sequenceCrossover	$.studyDesign.studyArms[].studyCells[].studyEpoch.name	MULTI
arms.notes	$.extensionAttributes.notes	MULTI
arms.pageNumber	$.extensionAttributes.pageNumber	MULTI
arms.pageSection	$.extensionAttributes.pageSection	MULTI
population_and_cohorts.populationId	$.studyDesign.population.id	MULTI
population_and_cohorts.populationName	$.studyDesign.population.name	MULTI
population_and_cohorts.populationCategory	$.studyDesign.population.populationType.code	MULTI
population_and_cohorts.description	$.studyDesign.population.description	MULTI
population_and_cohorts.plannedN	$.studyDesign.population.plannedSubjectsNumber	MULTI
population_and_cohorts.plannednType	$.studyDesign.population.plannedSubjectsNumberType.code	MULTI
population_and_cohorts.plannedN_type	$.studyDesign.population.plannedSubjectsNumberType.code	MULTI
population_and_cohorts.actualN	$.extensionAttributes.actualN	MULTI
population_and_cohorts.inclusionCriteriaIDs	$.studyDesign.population.criteria[?(@.category.code=='INCLUSION')].id	LIST
population_and_cohorts.exclusionCriteriaIDs	$.studyDesign.population.criteria[?(@.category.code=='EXCLUSION')].id	LIST
population_and_cohorts.criteriaReferenceMode	$.extensionAttributes.criteriaReferenceMode	MULTI
population_and_cohorts.linkedArmIDs	$.studyDesign.population.linkedArmIds	LIST
population_and_cohorts.assumption	$.extensionAttributes.assumption	MULTI
population_and_cohorts.notes	$.extensionAttributes.notes	MULTI
population_and_cohorts.pageNumber	$.extensionAttributes.pageNumber	MULTI
epochs.epochId	$.studyDesign.studyEpochs[*].id	list_item
epochs.epochName	$.studyDesign.studyEpochs[*].name	list_item
epochs.epochType	$.studyDesign.studyEpochs[*].typeCode	list_item
epochs.purpose	$.studyDesign.studyEpochs[*].description	list_item
epochs.duration	$.studyDesign.studyEpochs[*].duration	list_item
epochs.sequenceInStudy	$.studyDesign.studyEpochs[*].sequenceInStudy	list_item
epochs.transitionRule	$.studyDesign.studyEpochs[*].transitionRule	list_item
epochs.notes	$.extensionAttributes.notes	list_item
epochs.pageNumber	$.extensionAttributes.pageNumber	list_item
epochs.pageSection	$.extensionAttributes.pageSection	list_item
encounters_and_visits.encId	$.studyDesign.encounters[*].id	list_item
encounters_and_visits.encounterName	$.studyDesign.encounters[*].name	list_item
encounters_and_visits.visitLabel	$.studyDesign.encounters[*].label	list_item
encounters_and_visits.purpose	$.studyDesign.encounters[*].description	list_item
encounters_and_visits.epochReference	$.studyDesign.encounters[*].studyEpoch.id	list_item
encounters_and_visits.studyDay	$.studyDesign.encounters[*].studyDay.value	list_item
encounters_and_visits.windowMinus	$.studyDesign.encounters[*].windowBefore	list_item
encounters_and_visits.windowPlus	$.studyDesign.encounters[*].windowAfter	list_item
encounters_and_visits.duration	$.studyDesign.encounters[*].duration	list_item
encounters_and_visits.mode	$.studyDesign.encounters[*].typeCode	list_item
encounters_and_visits.location	$.studyDesign.encounters[].locationTypes[].code	list_item
encounters_and_visits.required	$.studyDesign.encounters[*].mandatoryFlag	list_item
encounters_and_visits.overnightStay	$.extensionAttributes.overnightStay	list_item
encounters_and_visits.labsRequired	$.extensionAttributes.labsRequired	list_item
encounters_and_visits.activitiesPerformed	$.studyDesign.encounters[*].scheduledActivities	list_item
encounters_and_visits.pageNumber	$.extensionAttributes.pageNumber	list_item
encounters_and_visits.pageSection	$.extensionAttributes.pageSection	list_item
interventions.interventionId	$.studyDesign.studyInterventions[*].id	list_item
interventions.name	$.studyDesign.studyInterventions[*].name	list_item
interventions.label	$.studyDesign.studyInterventions[*].label	list_item
interventions.type	$.studyDesign.studyInterventions[*].typeCode	list_item
interventions.description	$.studyDesign.studyInterventions[*].description	list_item
interventions.dose	$.studyDesign.studyInterventions[*].dose	list_item
interventions.doseUnits	$.studyDesign.studyInterventions[*].doseUnit.code	list_item
interventions.frequency	$.studyDesign.studyInterventions[*].frequency.code	list_item
interventions.route	$.studyDesign.studyInterventions[*].route.code	list_item
interventions.formulation	$.studyDesign.studyInterventions[*].productDesignation.code	list_item
interventions.duration	$.studyDesign.studyInterventions[*].duration	list_item
interventions.crossoverPeriod	$.extensionAttributes.crossoverPeriod	conditional
interventions.manufacturer	$.extensionAttributes.manufacturer	list_item
interventions.indNumber	$.studyDesign.studyInterventions[*].codes[?(@.typeCode=='IND')].code	list_item
interventions.assumptionNotes	$.extensionAttributes.assumptionNotes	list_item
interventions.pageNumber	$.extensionAttributes.pageNumber	list_item
interventions.pageSection	$.extensionAttributes.pageSection	list_item
eligibility_criteria.criterionId	$.studyDesign.population.criteria[*].id	list_item
eligibility_criteria.category	$.studyDesign.population.criteria[*].category.code	list_item
eligibility_criteria.text	$.studyDesign.population.criteria[*].text	list_item
eligibility_criteria.identifier	$.studyDesign.population.criteria[*].identifier	list_item
eligibility_criteria.structured	$.studyDesign.population.criteria[*].dictionaryCriteria	list_item
eligibility_criteria.operator	$.studyDesign.population.criteria[].dictionaryCriteria[].operator.code	list_item
eligibility_criteria.value	$.studyDesign.population.criteria[].dictionaryCriteria[].value	list_item
eligibility_criteria.units	$.studyDesign.population.criteria[].dictionaryCriteria[].unit.code	list_item
eligibility_criteria.timeframe	$.extensionAttributes.timeframe	list_item
eligibility_criteria.negationFlag	$.studyDesign.population.criteria[].dictionaryCriteria[].negationFlag	list_item
eligibility_criteria.assumption	$.extensionAttributes.assumption	list_item
eligibility_criteria.notes	$.extensionAttributes.notes	list_item
eligibility_criteria.pageNumber	$.extensionAttributes.pageNumber	list_item
crossover_design.sequenceId	$.studyDesign.studyArms[].studyCells[].id	conditional
crossover_design.sequenceName	$.studyDesign.studyArms[*].name	conditional
crossover_design.sequencePattern	$.extensionAttributes.sequencePattern	conditional
crossover_design.description	$.studyDesign.description	conditional
crossover_design.numberOfPeriods	$.studyDesign.studyEpochs[?(@.typeCode=='TREATMENT')].length()	conditional
crossover_design.periodInterventions	$.studyDesign.studyArms[].studyCells[].studyInterventions	conditional
crossover_design.washoutDuration	$.studyDesign.studyEpochs[?(@.typeCode=='WASHOUT')].duration	conditional
crossover_design.randomizationRatio	$.studyDesign.ratioAllocation	conditional
crossover_design.blockSize	$.extensionAttributes.blockSize	conditional
crossover_design.balancingFactor	$.extensionAttributes.balancingFactor	conditional
crossover_design.expectedN	$.studyDesign.population.plannedSubjectsNumber	conditional
crossover_design.pageNumber	$.extensionAttributes.pageNumber	conditional
crossover_design.pageSection	$.extensionAttributes.pageSection	conditional
objectives_and_endpoints.oeId	$.studyDesign.objectives[*].id	list_item
objectives_and_endpoints.name	$.studyDesign.objectives[*].name	list_item
objectives_and_endpoints.recordType	$.studyDesign.objectives[*].objectiveLevel.code	list_item
objectives_and_endpoints.level	$.studyDesign.objectives[*].objectiveLevel.code	list_item
objectives_and_endpoints.description	$.studyDesign.objectives[*].text	list_item
objectives_and_endpoints.purpose	$.studyDesign.objectives[*].description	list_item
objectives_and_endpoints.measurement	$.studyDesign.objectives[].endpoints[].name	list_item
objectives_and_endpoints.assessmentMethod	$.studyDesign.objectives[].endpoints[].purpose.code	list_item
objectives_and_endpoints.timepoint	$.studyDesign.objectives[].endpoints[].timepoints[*].value	list_item
objectives_and_endpoints.windowLow	$.studyDesign.objectives[].endpoints[].timepoints[*].windowLow	list_item
objectives_and_endpoints.windowHigh	$.studyDesign.objectives[].endpoints[].timepoints[*].windowHigh	list_item
objectives_and_endpoints.units	$.studyDesign.objectives[].endpoints[].unit.code	list_item
objectives_and_endpoints.statisticalMethod	$.studyDesign.objectives[].endpoints[].statisticalAnalysisPlan	list_item
objectives_and_endpoints.activityRefsText	$.extensionAttributes.activityRefsText	list_item
objectives_and_endpoints.encounterRefsText	$.extensionAttributes.encounterRefsText	list_item
objectives_and_endpoints.assumptionNotes	$.extensionAttributes.assumptionNotes	list_item
objectives_and_endpoints.pageNumber	$.extensionAttributes.pageNumber	list_item
activities.activityId	$.studyDesign.activities[*].id	list_item
activities.activityName	$.studyDesign.activities[*].name	list_item
activities.activityLabel	$.studyDesign.activities[*].label	list_item
activities.description	$.studyDesign.activities[*].description	list_item
activities.dataType	$.studyDesign.activities[*].definedProcedure.procedureType.code	list_item
activities.collectionMethod	$.studyDesign.activities[*].definedProcedure.methodType.code	list_item
activities.specimenType	$.studyDesign.activities[*].definedProcedure.specimenType.code	list_item
activities.frequency	$.extensionAttributes.frequency	list_item
activities.units	$.studyDesign.activities[*].definedProcedure.unit.code	list_item
activities.normalRange	$.extensionAttributes.normalRange	list_item
activities.assumption	$.extensionAttributes.assumption	list_item
activities.notes	$.extensionAttributes.notes	list_item
activities.pageNumber	$.extensionAttributes.pageNumber	list_item
activities.pageSection	$.extensionAttributes.pageSection	list_item
activities.activityCategory	$.extensionAttributes.activityCategory	list_item
activities.activityProcedure	$.extensionAttributes.activityProcedure	list_item
activities.assumptionNotes	$.extensionAttributes.assumptionNotes	list_item
activities.categorySequence	$.extensionAttributes.categorySequence	list_item
activities.footnoteMarkersUsed	$.extensionAttributes.footnoteMarkersUsed	list_item
activities.footnoteText	$.extensionAttributes.footnoteText	list_item
activities.visitHeaderText	$.extensionAttributes.visitHeaderText	list_item
activities.visitScheduleText	$.extensionAttributes.visitScheduleText	list_item
study_cells.cellId	$.studyDesign.studyArms[].studyCells[].id	list_item
study_cells.cellName	$.studyDesign.studyArms[].studyCells[].studyEpoch.name	list_item
study_cells.descriptionText	$.extensionAttributes.descriptionText	list_item
study_cells.purposeText	$.extensionAttributes.purposeText	list_item
study_cells.armRefsText	$.studyDesign.studyArms[].studyCells[].studyArm.name	list_item
study_cells.epochRefsText	$.studyDesign.studyArms[].studyCells[].studyEpoch.name	list_item
study_cells.interventionRefsText	$.studyDesign.studyArms[].studyCells[].studyInterventions[*].name	list_item
study_cells.activityRefsText	$.studyDesign.studyArms[].studyCells[].studyActivities[*].name	list_item
study_cells.durationText	$.extensionAttributes.durationText	list_item
study_cells.transitionRuleText	$.studyDesign.studyArms[].studyCells[].studyEpoch.transitionRule	list_item
study_cells.assumptionNotes	$.extensionAttributes.assumptionNotes	list_item
study_cells.pageNumber	$.extensionAttributes.pageNumber	list_item
study_cells.pageSection	$.extensionAttributes.pageSection	list_item
soa_activity.activityId	$.studyDesign.studyCells[].studyActivities[].id	list_item
soa_activity.activityProcedure	$.studyDesign.studyCells[].studyActivities[].definedProcedure.name	list_item
soa_activity.activityCategory	$.studyDesign.studyCells[].studyActivities[].definedProcedure.procedureType.code	list_item
soa_activity.categorySequence	$.SYSTEM_GENERATED	list_item
soa_activity.description	$.studyDesign.studyCells[].studyActivities[].description	list_item
soa_activity.visitHeaderText	$.extensionAttributes.visitHeaderText	list_item
soa_activity.visitScheduleText	$.extensionAttributes.visitScheduleText	list_item
soa_activity.footnoteMarkersUsed	$.extensionAttributes.footnoteMarkersUsed	list_item
soa_activity.footnoteText	$.extensionAttributes.footnoteText	list_item
soa_activity.assumptionNotes	$.extensionAttributes.assumptionNotes	list_item
soa_activity.pageNumber	$.extensionAttributes.pageNumber	list_item
soa_activity.pageSection	$.extensionAttributes.pageSection	list_item
soa_visit.visitId	$.studyDesign.encounters[*].id	list_item
soa_visit.visitName	$.studyDesign.encounters[*].name	list_item
soa_visit.visitOrder	$.studyDesign.encounters[*].studyDay.value	list_item
soa_visit.contextType	$.studyDesign.encounters[*].typeCode	list_item
soa_visit.contextValue	$.studyDesign.encounters[*].studyDay.value	list_item
soa_visit.pageNumber	$.extensionAttributes.pageNumber	list_item
soa_visit.pageSection	$.extensionAttributes.pageSection	list_item
safety_monitoring.monitoringId	$.studyDesign.safetyMonitoring[*].id	list_item
safety_monitoring.type	$.studyDesign.safetyMonitoring[*].typeCode	list_item
safety_monitoring.description	$.studyDesign.safetyMonitoring[*].description	list_item
safety_monitoring.schedule	$.studyDesign.safetyMonitoring[*].frequency.code	list_item
safety_monitoring.reportingWindow	$.studyDesign.safetyMonitoring[*].reportingWindow	list_item
safety_monitoring.escalationCriteria	$.extensionAttributes.escalationCriteria	list_item
safety_monitoring.gradingScale	$.extensionAttributes.gradingScale	list_item
safety_monitoring.action	$.extensionAttributes.action	list_item
safety_monitoring.endpointParameter	$.extensionAttributes.endpointParameter	list_item
safety_monitoring.encounterId	$.extensionAttributes.encounterId	list_item
safety_monitoring.assumptionNotes	$.extensionAttributes.assumptionNotes	list_item
safety_monitoring.pageNumber	$.extensionAttributes.pageNumber	list_item
protocol_version.versionId	$.studyDesign.studyProtocolVersions[*].id	singleton
protocol_version.versionNumber	$.studyDesign.studyProtocolVersions[*].protocolVersion	singleton
protocol_version.amendmentNumber	$.studyDesign.studyProtocolVersions[*].protocolAmendment	singleton
protocol_version.approvalDate	$.studyDesign.studyProtocolVersions[*].dateValues[?(@.typeCode=='APPROVAL')].dateValue	singleton
protocol_version.effectiveDate	$.studyDesign.studyProtocolVersions[*].dateValues[?(@.typeCode=='EFFECTIVE')].dateValue	singleton
protocol_version.reasonForAmendment	$.studyDesign.studyProtocolVersions[*].description	singleton
protocol_version.sectionsModified	$.extensionAttributes.sectionsModified	singleton
protocol_version.substantialChange	$.extensionAttributes.substantialChange	singleton
protocol_version.regulatoryStatus	$.extensionAttributes.regulatoryStatus	singleton
protocol_version.subjectsEnrolled	$.extensionAttributes.subjectsEnrolled	singleton
protocol_version.notes	$.extensionAttributes.notes	singleton
protocol_version.evidencePageNumbers	$.extensionAttributes.evidencePageNumbers	singleton
protocol_version.isLatestByOrdering	$.extensionAttributes.isLatestByOrdering	singleton
protocol_version.lifecycleStatus	$.extensionAttributes.lifecycleStatus	singleton
protocol_version.orderingMethod	$.extensionAttributes.orderingMethod	singleton
protocol_version.versionIdentifier	$.studyDesign.studyProtocolVersions[*].id	singleton
protocol_version.versionNotes	$.extensionAttributes.versionNotes	singleton
protocol_version.versionNumberRaw	$.extensionAttributes.versionNumberRaw	singleton