FHIRsmith: ValueSet/ValueSet-udp-section-codes-vs.json

FHIR IG analytics

Package	hl7.fhir.uv.clinical-study-protocol
Resource Type	ValueSet
Id	ValueSet-udp-section-codes-vs.json
FHIR Version	R6
Source	https://build.fhir.org/ig/HL7/vulcan-udp-ig/ValueSet-udp-section-codes-vs.html
URL	http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-section-codes-vs
Version	1.0.0-ballot2
Status	active
Date	2026-03-30T16:32:09+00:00
Name	UDPSectionCodesVS
Title	UDP Section Codes Value Set
Realm	uv
Authority	hl7
Description	Codes representing sections of M11. This value set is not identified in the M11 specification but is in the NCI Thesaurus and was originally specified for M11. It is NCI Value Set C217272. These codes are present in UDP to allow granularity in narrative compositions.

Resources that use this resource

StructureDefinition
hl7.fhir.uv.clinical-study-protocol#current	m11-amendment-detail	M11_AmendmentDetails
hl7.fhir.uv.clinical-study-protocol#current	m11-research-study-narratives	Research Study Narratives

Resources that this resource uses

CodeSystem
hl7.fhir.uv.clinical-study-protocol#current	Thesaurus.owl	Fragment of NCIT Code System

Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: ValueSet udp-section-codes-vs

Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version 📦1.0.0-ballot2

Code	Display	Definition
C222769	ICH M11 Protocol Section Title Page	Title Page Section of the ICH M11 Protocol standard, Title Page.
C218514	ICH M11 Protocol Section 1 PROTOCOL SUMMARY	The title of section 1 of the ICH M11 protocol guideline: PROTOCOL SUMMARY.
C218515	ICH M11 Protocol Section 1.1 Protocol Synopsis	The title of section 1.1 of the ICH M11 protocol guideline: Protocol Synopsis.
C218516	ICH M11 Protocol Section 1.1.1 Primary and Secondary Objectives and Estimands	The title of section 1.1.1 of the ICH M11 protocol guideline: Primary and Secondary Objectives and Estimands.
C218517	ICH M11 Protocol Section 1.1.2 Overall Design	The title of section 1.1.2 of the ICH M11 protocol guideline: Overall Design.
C218518	ICH M11 Protocol Section 1.2 Trial Schema	The title of section 1.2 of the ICH M11 protocol guideline: Trial Schema.
C218519	ICH M11 Protocol Section 1.3 Schedule of Activities	The title of section 1.3 of the ICH M11 protocol guideline: Schedule of Activities.
C218520	ICH M11 Protocol Section 2 INTRODUCTION	The title of section 2 of the ICH M11 protocol guideline: INTRODUCTION.
C218521	ICH M11 Protocol Section 2.1 Purpose of Trial	The title of section 2.1 of the ICH M11 protocol guideline: Purpose of Trial.
C218522	ICH M11 Protocol Section 2.2 Assessment of Risks and Benefits	The title of section 2.2 of the ICH M11 protocol guideline: Assessment of Risks and Benefits.
C218523	ICH M11 Protocol Section 2.2.1 Risk Summary and Mitigation Strategy	The title of section 2.2.2 of the ICH M11 protocol guideline: Risk Summary and Mitigation Strategy.
C218524	ICH M11 Protocol Section 2.2.2 Benefit Summary	The title of section 2.2.1 of the ICH M11 protocol guideline: Benefit Summary.
C218525	ICH M11 Protocol Section 2.2.3 Overall Risk-Benefit Assessment	The title of section 2.2.3 of the ICH M11 protocol guideline: Overall Risk-Benefit Assessment.
C218526	ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS	The title of section 3 of the ICH M11 protocol guideline: TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS.
C218527	ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s)	The title of section 3.1 of the ICH M11 protocol guideline: Primary Objective(s) and Associated Estimand(s).
C218528	ICH M11 Protocol Section 3.1.1 Primary Objective	The title of section 3.1.1 of the ICH M11 protocol guideline: Primary Objective.
C218529	ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s)	The title of section 3.2 of the ICH M11 protocol guideline: Secondary Objective(s) and Associated Estimand(s).
C218530	ICH M11 Protocol Section 3.2.1 Secondary Objective	The title of section 3.2.1 of the ICH M11 protocol guideline: Secondary Objective.
C218531	ICH M11 Protocol Section 3.3 Exploratory Objective(s)	The title of section 3.3 of the ICH M11 protocol guideline: Exploratory Objective(s).
C218532	ICH M11 Protocol Section 3.3.1 Exploratory Objective	The title of section 3.3.1 of the ICH M11 protocol guideline: Exploratory Objective.
C218533	ICH M11 Protocol Section 4 TRIAL DESIGN	The title of section 4 of the ICH M11 protocol guideline: TRIAL DESIGN.
C218534	ICH M11 Protocol Section 4.1 Description of Trial Design	The title of section 4.1 of the ICH M11 protocol guideline: Description of Trial Design.
C218535	ICH M11 Protocol Section 4.1.1 Stakeholder Input into Design	The title of section 4.1.1 of the ICH M11 protocol guideline: Stakeholder Input into Design.
C218536	ICH M11 Protocol Section 4.2 Rationale for Trial Design	The title of section 4.2 of the ICH M11 protocol guideline: Rationale for Trial Design.
C218537	ICH M11 Protocol Section 4.2.1 Rationale for Estimand(s)	The title of section 4.2.1 of the ICH M11 protocol guideline: Rationale for Estimand(s).
C218538	ICH M11 Protocol Section 4.2.2 Rationale for Intervention Model	The title of section 4.2.2 of the ICH M11 protocol guideline: Rationale for Intervention Model.
C218539	ICH M11 Protocol Section 4.2.3 Rationale for Control Type	The title of section 4.2.3 of the ICH M11 protocol guideline: Rationale for Control Type.
C218540	ICH M11 Protocol Section 4.2.4 Rationale for Trial Duration	The title of section 4.2.4 of the ICH M11 protocol guideline: Rationale for Trial Duration.
C218541	ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial Design	The title of section 4.2.5 of the ICH M11 protocol guideline: Rationale for Adaptive or Novel Trial Design.
C218542	ICH M11 Protocol Section 4.2.6 Rationale for Interim Analysis	The title of section 4.2.6 of the ICH M11 protocol guideline: Rationale for Interim Analysis.
C218543	ICH M11 Protocol Section 4.2.7 Rationale for Other Trial Design Aspects	The title of section 4.2.7 of the ICH M11 protocol guideline: Rationale for Other Trial Design Aspects.
C218544	ICH M11 Protocol Section 4.3 Trial Stopping Rules	The title of section 4.3 of the ICH M11 protocol guideline: Trial Stopping Rules.
C218545	ICH M11 Protocol Section 4.4 Start of Trial and End of Trial	The title of section 4.4 of the ICH M11 protocol guideline: Start of Trial and End of Trial.
C218546	ICH M11 Protocol Section 4.5 Access to Trial Intervention After End of Trial	The title of section 4.5 of the ICH M11 protocol guideline: Access to Trial Intervention After End of Trial.
C218547	ICH M11 Protocol Section 5 TRIAL POPULATION	The title of section 5 of the ICH M11 protocol guideline: TRIAL POPULATION.
C218548	ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale	The title of section 5.1 of the ICH M11 protocol guideline: Description of Trial Population and Rationale.
C218549	ICH M11 Protocol Section 5.2 Inclusion Criteria	The title of section 5.2 of the ICH M11 protocol guideline: Inclusion Criteria.
C218550	ICH M11 Protocol Section 5.3 Exclusion Criteria	The title of section 5.3 of the ICH M11 protocol guideline: Exclusion Criteria.
C218551	ICH M11 Protocol Section 5.4 Contraception	The title of section 5.4 of the ICH M11 protocol guideline: Contraception.
C218552	ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential	The title of section 5.4.1 of the ICH M11 protocol guideline: Definitions Related to Childbearing Potential.
C218553	ICH M11 Protocol Section 5.4.2 Contraception Requirements	The title of section 5.4.2 of the ICH M11 protocol guideline: Contraception Requirements.
C218554	ICH M11 Protocol Section 5.5 Lifestyle Restrictions	The title of section 5.5 of the ICH M11 protocol guideline: Lifestyle Restrictions.
C218555	ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions	The title of section 5.5.1 of the ICH M11 protocol guideline: Meals and Dietary Restrictions.
C218556	ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions	The title of section 5.5.2 of the ICH M11 protocol guideline: Caffeine, Alcohol, Tobacco, and Other Restrictions.
C218557	ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions	The title of section 5.5.3 of the ICH M11 protocol guideline: Physical Activity Restrictions.
C218558	ICH M11 Protocol Section 5.5.4 Other Activity Restrictions	The title of section 5.5.4 of the ICH M11 protocol guideline: Other Activity Restrictions.
C218559	ICH M11 Protocol Section 5.6 Screen Failure and Rescreening	The title of section 5.6 of the ICH M11 protocol guideline: Screen Failure and Rescreening.
C218560	ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY	The title of section 6 of the ICH M11 protocol guideline: TRIAL INTERVENTION AND CONCOMITANT THERAPY.
C218561	ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention	The title of section 6.1 of the ICH M11 protocol guideline: Description of Investigational Trial Intervention.
C218562	ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen	The title of section 6.2 of the ICH M11 protocol guideline: Rationale for Investigational Trial Intervention Dose and Regimen.
C218563	ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration	The title of section 6.3 of the ICH M11 protocol guideline: Investigational Trial Intervention Administration.
C218564	ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification	The title of section 6.4 of the ICH M11 protocol guideline: Investigational Trial Intervention Dose Modification.
C218565	ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose	The title of section 6.5 of the ICH M11 protocol guideline: Management of Investigational Trial Intervention Overdose.
C218566	ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention	The title of section 6.6 of the ICH M11 protocol guideline: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention.
C218567	ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention	The title of section 6.6.1 of the ICH M11 protocol guideline: Preparation of Investigational Trial Intervention.
C218568	ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention	The title of section 6.6.2 of the ICH M11 protocol guideline: Storage and Handling of Investigational Trial Intervention.
C218569	ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention	The title of section 6.6.3 of the ICH M11 protocol guideline: Accountability of Investigational Trial Intervention.
C218570	ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding	The title of section 6.7 of the ICH M11 protocol guideline: Investigational Trial Intervention Assignment, Randomisation and Blinding.
C218571	ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention	The title of section 6.7.1 of the ICH M11 protocol guideline: Participant Assignment to Investigational Trial Intervention.
C218572	ICH M11 Protocol Section 6.7.2 Randomisation	The title of section 6.7.2 of the ICH M11 protocol guideline: Randomisation.
C218573	ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding	The title of section 6.7.3 of the ICH M11 protocol guideline: Measures to Maintain Blinding.
C218574	ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site	The title of section 6.7.4 of the ICH M11 protocol guideline: Emergency Unblinding at the Site.
C218575	ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence	The title of section 6.8 of the ICH M11 protocol guideline: Investigational Trial Intervention Adherence.
C218576	ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention	The title of section 6.9 of the ICH M11 protocol guideline: Description of Noninvestigational Trial Intervention.
C218577	ICH M11 Protocol Section 6.9.1 Background Trial Intervention	The title of section 6.9.1 of the ICH M11 protocol guideline: Background Trial Intervention.
C218578	ICH M11 Protocol Section 6.9.2 Rescue Therapy	The title of section 6.9.2 of the ICH M11 protocol guideline: Rescue Therapy.
C218579	ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention	The title of section 6.9.3 of the ICH M11 protocol guideline: Other Noninvestigational Trial Intervention.
C218580	ICH M11 Protocol Section 6.10 Concomitant Therapy	The title of section 6.10 of the ICH M11 protocol guideline: Concomitant Therapy.
C218581	ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy	The title of section 6.10.1 of the ICH M11 protocol guideline: Prohibited Concomitant Therapy.
C218582	ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy	The title of section 6.10.2 of the ICH M11 protocol guideline: Permitted Concomitant Therapy.
C218583	ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL	The title of section 7 of the ICH M11 protocol guideline: PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL.
C218584	ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants	The title of section 7.1 of the ICH M11 protocol guideline: Discontinuation of Trial Intervention for Individual Participants.
C218585	ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention	The title of section 7.1.1 of the ICH M11 protocol guideline: Permanent Discontinuation of Trial Intervention.
C218586	ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention	The title of section 7.1.2 of the ICH M11 protocol guideline: Temporary Discontinuation of Trial Intervention.
C218587	ICH M11 Protocol Section 7.1.3 Rechallenge	The title of section 7.1.3 of the ICH M11 protocol guideline: Rechallenge.
C218588	ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial	The title of section 7.2 of the ICH M11 protocol guideline: Participant Discontinuation or Withdrawal from the Trial.
C218589	ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up	The title of section 7.3 of the ICH M11 protocol guideline: Management of Loss to Follow-Up.
C218590	ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES	The title of section 8 of the ICH M11 protocol guideline: TRIAL ASSESSMENTS AND PROCEDURES.
C218591	ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations	The title of section 8.1 of the ICH M11 protocol guideline: Trial Assessments and Procedures Considerations.
C218592	ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures	The title of section 8.2 of the ICH M11 protocol guideline: Screening/Baseline Assessments and Procedures.
C218593	ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures	The title of section 8.3 of the ICH M11 protocol guideline: Efficacy Assessments and Procedures.
C218594	ICH M11 Protocol Section 8.4 Safety Assessments and Procedures	The title of section 8.4 of the ICH M11 protocol guideline: Safety Assessments and Procedures.
C218595	ICH M11 Protocol Section 8.4.1 Physical Examination	The title of section 8.4.1 of the ICH M11 protocol guideline: Physical Examination.
C218596	ICH M11 Protocol Section 8.4.2 Vital Signs	The title of section 8.4.2 of the ICH M11 protocol guideline: Vital Signs.
C218597	ICH M11 Protocol Section 8.4.3 Electrocardiograms	The title of section 8.4.3 of the ICH M11 protocol guideline: Electrocardiograms.
C218598	ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments	The title of section 8.4.4 of the ICH M11 protocol guideline: Clinical Laboratory Assessments.
C218599	ICH M11 Protocol Section 8.4.5 Pregnancy Testing	The title of section 8.4.5 of the ICH M11 protocol guideline: Pregnancy Testing.
C218600	ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring	The title of section 8.4.6 of the ICH M11 protocol guideline: Suicidal Ideation and Behaviour Risk Monitoring.
C218601	ICH M11 Protocol Section 8.5 Pharmacokinetics	The title of section 8.5 of the ICH M11 protocol guideline: Pharmacokinetics.
C218602	ICH M11 Protocol Section 8.6 Biomarkers	The title of section 8.6 of the ICH M11 protocol guideline: Biomarkers.
C218603	ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics	The title of section 8.6.1 of the ICH M11 protocol guideline: Genetics, Genomics, Pharmacogenetics and Pharmacogenomics.
C218604	ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers	The title of section 8.6.2 of the ICH M11 protocol guideline: Pharmacodynamic Biomarkers.
C218605	ICH M11 Protocol Section 8.6.3 Other Biomarkers	The title of section 8.6.3 of the ICH M11 protocol guideline: Other Biomarkers.
C218606	ICH M11 Protocol Section 8.7 Immunogenicity Assessments	The title of section 8.7 of the ICH M11 protocol guideline: Immunogenicity Assessments.
C218607	ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics	The title of section 8.8 of the ICH M11 protocol guideline: Medical Resource Utilisation and Health Economics.
C218608	ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS	The title of section 9 of the ICH M11 protocol guideline: ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS.
C218609	ICH M11 Protocol Section 9.1 Definitions	The title of section 9.1 of the ICH M11 protocol guideline: Definitions.
C218610	ICH M11 Protocol Section 9.1.1 Definitions of Adverse Events	The title of section 9.1.1 of the ICH M11 protocol guideline: Definitions of Adverse Events.
C218611	ICH M11 Protocol Section 9.1.2 Definitions of Serious Adverse Events	The title of section 9.1.2 of the ICH M11 protocol guideline: Definitions of Serious Adverse Events.
C218612	ICH M11 Protocol Section 9.1.3 Definitions of Product Complaints	The title of section 9.1.3 of the ICH M11 protocol guideline: Definitions of Product Complaints.
C218613	ICH M11 Protocol Section 9.1.3.1 Definitions of Medical Device Product Complaints	The title of section 9.1.3.1 of the ICH M11 protocol guideline: Definitions of Medical Device Product Complaints.
C218614	ICH M11 Protocol Section 9.2 Timing and Procedures for Collection and Reporting	The title of section 9.2 of the ICH M11 protocol guideline: Timing and Procedures for Collection and Reporting.
C218615	ICH M11 Protocol Section 9.2.1 Timing	The title of section 9.2.1 of the ICH M11 protocol guideline: Timing.
C218616	ICH M11 Protocol Section 9.2.2 Collection Procedures	The title of section 9.2.2 of the ICH M11 protocol guideline: Collection Procedures.
C218617	ICH M11 Protocol Section 9.2.3 Reporting	The title of section 9.2.3 of the ICH M11 protocol guideline: Reporting.
C218618	ICH M11 Protocol Section 9.2.3.1 Regulatory Reporting Requirements	The title of section 9.2.3.1 of the ICH M11 protocol guideline: Regulatory Reporting Requirements.
C218619	ICH M11 Protocol Section 9.2.4 Adverse Events of Special Interest	The title of section 9.2.4 of the ICH M11 protocol guideline: Adverse Events of Special Interest.
C218620	ICH M11 Protocol Section 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs	The title of section 9.2.5 of the ICH M11 protocol guideline: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs.
C218621	ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information	The title of section 9.3 of the ICH M11 protocol guideline: Pregnancy and Postpartum Information.
C218622	ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the Trial	The title of section 9.3.1 of the ICH M11 protocol guideline: Participants Who Become Pregnant During the Trial.
C218623	ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the Trial	The title of section 9.3.2 of the ICH M11 protocol guideline: Participants Whose Partners Become Pregnant During the Trial.
C218624	ICH M11 Protocol Section 9.4 Special Safety Situations	The title of section 9.4 of the ICH M11 protocol guideline: Special Safety Situations.
C218625	ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS	The title of section 10 of the ICH M11 protocol guideline: STATISTICAL CONSIDERATIONS.
C218626	ICH M11 Protocol Section 10.1 General Considerations	The title of section 10.1 of the ICH M11 protocol guideline: General Considerations.
C218627	ICH M11 Protocol Section 10.2 Analysis Sets	The title of section 10.2 of the ICH M11 protocol guideline: Analysis Sets.
C218628	ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables	The title of section 10.3 of the ICH M11 protocol guideline: Analyses of Demographics and Other Baseline Variables.
C218629	ICH M11 Protocol Section 10.4 Analyses Associated with the Primary Objective(s)	The title of section 10.4 of the ICH M11 protocol guideline: Analyses Associated with the Primary Objective(s).
C218630	ICH M11 Protocol Section 10.4.1 Primary Objective	The title of section 10.4.1 of the ICH M11 protocol guideline: Primary Objective.
C218631	ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method	The title of section 10.4.1.1 of the ICH M11 protocol guideline: Statistical Analysis Method.
C218632	ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)	The title of section 10.4.1.2 of the ICH M11 protocol guideline: Handling of Data in Relation to Primary Estimand(s).
C218633	ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)	The title of section 10.4.1.3 of the ICH M11 protocol guideline: Handling of Missing Data in Relation to Primary Estimand(s)
C218634	ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis	The title of section 10.4.1.4 of the ICH M11 protocol guideline: Sensitivity Analysis.
C218635	ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis	The title of section 10.4.1.5 of the ICH M11 protocol guideline: Supplementary Analysis.
C218636	ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)	The title of section 10.5 of the ICH M11 protocol guideline: Analyses Associated with the Secondary Objective(s).
C218637	ICH M11 Protocol Section 10.5.1 Secondary Objective	The title of section 10.5.1 of the ICH M11 protocol guideline: Secondary Objective.
C218638	ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method	The title of section 10.5.1.1 of the ICH M11 protocol guideline: Statistical Analysis Method.
C218639	ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)	The title of section 10.5.1.2 of the ICH M11 protocol guideline: Handling of Data in Relation to Secondary Estimand(s).
C218640	ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)	The title of section 10.5.1.3 of the ICH M11 protocol guideline: Handling of Missing Data in Relation to Secondary Estimand(s).
C218641	ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis	The title of section 10.5.1.4 of the ICH M11 protocol guideline: Sensitivity Analysis.
C218642	ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis	The title of section 10.5.1.5 of the ICH M11 protocol guideline: Supplementary Analysis.
C218643	ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)	The title of section 10.6 of the ICH M11 protocol guideline: Analyses Associated with the Exploratory Objective(s).
C218644	ICH M11 Protocol Section 10.7 Safety Analyses	The title of section 10.7 of the ICH M11 protocol guideline: Safety Analyses.
C218645	ICH M11 Protocol Section 10.8 Other Analyses	The title of section 10.8 of the ICH M11 protocol guideline: Other Analyses.
C218646	ICH M11 Protocol Section 10.9 Interim Analyses	The title of section 10.9 of the ICH M11 protocol guideline: Interim Analyses.
C218647	ICH M11 Protocol Section 10.10 Multiplicity Adjustments	The title of section 10.10 of the ICH M11 protocol guideline: Multiplicity Adjustments.
C218648	ICH M11 Protocol Section 10.11 Sample Size Determination	The title of section 10.11 of the ICH M11 protocol guideline: Sample Size Determination.
C218649	ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS	The title of section 11 of the ICH M11 protocol guideline: TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS.
C218650	ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations	The title of section 11.1 of the ICH M11 protocol guideline: Regulatory and Ethical Considerations.
C218651	ICH M11 Protocol Section 11.2 Trial Oversight	The title of section 11.2 of the ICH M11 protocol guideline: Trial Oversight.
C218652	ICH M11 Protocol Section 11.2.1 Investigator Responsibilities	The title of section 11.2.1 of the ICH M11 protocol guideline: Investigator Responsibilities.
C218653	ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities	The title of section 11.2.2 of the ICH M11 protocol guideline: Sponsor Responsibilities.
C218654	ICH M11 Protocol Section 11.3 Informed Consent Process	The title of section 11.3 of the ICH M11 protocol guideline: Informed Consent Process.
C218655	ICH M11 Protocol Section 11.3.1 Informed Consent for Rescreening	The title of section 11.3.1 of the ICH M11 protocol guideline: Informed Consent for Rescreening.
C218656	ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research	The title of section 11.3.2 of the ICH M11 protocol guideline: Informed Consent for Use of Remaining Samples in Exploratory Research.
C218657	ICH M11 Protocol Section 11.4 Committees	The title of section 11.4 of the ICH M11 protocol guideline: Committees.
C218658	ICH M11 Protocol Section 11.5 Insurance and Indemnity	The title of section 11.5 of the ICH M11 protocol guideline: Insurance and Indemnity.
C218659	ICH M11 Protocol Section 11.6 Risk-Based Quality Management	The title of section 11.6 of the ICH M11 protocol guideline: Risk-Based Quality Management.
C218660	ICH M11 Protocol Section 11.7 Data Governance	The title of section 11.7 of the ICH M11 protocol guideline: Data Governance.
C218661	ICH M11 Protocol Section 11.8 Data Protection	The title of section 11.8 of the ICH M11 protocol guideline: Data Protection.
C218662	ICH M11 Protocol Section 11.9 Source Records	The title of section 11.9 of the ICH M11 protocol guideline: Source Records.
C218663	ICH M11 Protocol Section 11.10 Protocol Deviations	The title of section 11.10 of the ICH M11 protocol guideline: Protocol Deviations.
C218664	ICH M11 Protocol Section 11.11 Early Site Closure	The title of section 11.11 of the ICH M11 protocol guideline: Early Site Closure.
C218665	ICH M11 Protocol Section 11.12 Data Dissemination	The title of section 11.12 of the ICH M11 protocol guideline: Data Dissemination.
C218666	ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS	The title of section 12 of the ICH M11 protocol guideline: APPENDIX: SUPPORTING DETAILS.
C218667	ICH M11 Protocol Section 12.1 Clinical Laboratory Tests	The title of section 12.1 of the ICH M11 protocol guideline: Clinical Laboratory Tests.
C218668	ICH M11 Protocol Section 12.2 Country/Region-Specific Differences	The title of section 12.2 of the ICH M11 protocol guideline: Country/Region-Specific Differences.
C218669	ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s)	The title of section 12.3 of the ICH M11 protocol guideline: Prior Protocol Amendment(s).
C218670	ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS	The title of section 13 of the ICH M11 protocol guideline: APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS.
C218671	ICH M11 Protocol Section 14 APPENDIX: REFERENCES	The title of section 14 of the ICH M11 protocol guideline: APPENDIX: REFERENCES.

Source1

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  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 2
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "brr"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "trial-use",
      "_valueCode": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical": "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"
          }
        ]
      }
    }
  ],
  "url": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-section-codes-vs",
  "version": "1.0.0-ballot2",
  "name": "UDPSectionCodesVS",
  "title": "UDP Section Codes Value Set",
  "status": "active",
  "experimental": false,
  "date": "2026-03-30T16:32:09+00:00",
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "contact": [
    {
      "name": "HL7 International / Biomedical Research and Regulation",
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/rcrim"
        },
        {
          "system": "email",
          "value": "UDP@HL7Vulcan.org"
        }
      ]
    }
  ],
  "description": "Codes representing sections of M11.\nThis value set is not identified in the M11 specification but is in the NCI Thesaurus and was \noriginally specified for M11.  It is NCI Value Set C217272.\nThese codes are present in UDP to allow granularity in narrative compositions.",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code": "001",
          "display": "World"
        }
      ]
    }
  ],
  "compose": {
    "include": [
      {
        "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "concept": [
          {
            "code": "C222769",
            "display": "ICH M11 Protocol Section Title Page"
          },
          {
            "code": "C218514",
            "display": "ICH M11 Protocol Section 1 PROTOCOL SUMMARY"
          },
          {
            "code": "C218515",
            "display": "ICH M11 Protocol Section 1.1 Protocol Synopsis"
          },
          {
            "code": "C218516",
            "display": "ICH M11 Protocol Section 1.1.1 Primary and Secondary Objectives and Estimands"
          },
          {
            "code": "C218517",
            "display": "ICH M11 Protocol Section 1.1.2 Overall Design"
          },
          {
            "code": "C218518",
            "display": "ICH M11 Protocol Section 1.2 Trial Schema"
          },
          {
            "code": "C218519",
            "display": "ICH M11 Protocol Section 1.3 Schedule of Activities"
          },
          {
            "code": "C218520",
            "display": "ICH M11 Protocol Section 2 INTRODUCTION"
          },
          {
            "code": "C218521",
            "display": "ICH M11 Protocol Section 2.1 Purpose of Trial"
          },
          {
            "code": "C218522",
            "display": "ICH M11 Protocol Section 2.2 Assessment of Risks and Benefits"
          },
          {
            "code": "C218523",
            "display": "ICH M11 Protocol Section 2.2.1 Risk Summary and Mitigation Strategy"
          },
          {
            "code": "C218524",
            "display": "ICH M11 Protocol Section 2.2.2 Benefit Summary"
          },
          {
            "code": "C218525",
            "display": "ICH M11 Protocol Section 2.2.3 Overall Risk-Benefit Assessment"
          },
          {
            "code": "C218526",
            "display": "ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS"
          },
          {
            "code": "C218527",
            "display": "ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s)"
          },
          {
            "code": "C218528",
            "display": "ICH M11 Protocol Section 3.1.1 Primary Objective"
          },
          {
            "code": "C218529",
            "display": "ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s)"
          },
          {
            "code": "C218530",
            "display": "ICH M11 Protocol Section 3.2.1 Secondary Objective"
          },
          {
            "code": "C218531",
            "display": "ICH M11 Protocol Section 3.3 Exploratory Objective(s)"
          },
          {
            "code": "C218532",
            "display": "ICH M11 Protocol Section 3.3.1 Exploratory Objective"
          },
          {
            "code": "C218533",
            "display": "ICH M11 Protocol Section 4 TRIAL DESIGN"
          },
          {
            "code": "C218534",
            "display": "ICH M11 Protocol Section 4.1 Description of Trial Design"
          },
          {
            "code": "C218535",
            "display": "ICH M11 Protocol Section 4.1.1 Stakeholder Input into Design"
          },
          {
            "code": "C218536",
            "display": "ICH M11 Protocol Section 4.2 Rationale for Trial Design"
          },
          {
            "code": "C218537",
            "display": "ICH M11 Protocol Section 4.2.1 Rationale for Estimand(s)"
          },
          {
            "code": "C218538",
            "display": "ICH M11 Protocol Section 4.2.2 Rationale for Intervention Model"
          },
          {
            "code": "C218539",
            "display": "ICH M11 Protocol Section 4.2.3 Rationale for Control Type"
          },
          {
            "code": "C218540",
            "display": "ICH M11 Protocol Section 4.2.4 Rationale for Trial Duration"
          },
          {
            "code": "C218541",
            "display": "ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial Design"
          },
          {
            "code": "C218542",
            "display": "ICH M11 Protocol Section 4.2.6 Rationale for Interim Analysis"
          },
          {
            "code": "C218543",
            "display": "ICH M11 Protocol Section 4.2.7 Rationale for Other Trial Design Aspects"
          },
          {
            "code": "C218544",
            "display": "ICH M11 Protocol Section 4.3 Trial Stopping Rules"
          },
          {
            "code": "C218545",
            "display": "ICH M11 Protocol Section 4.4 Start of Trial and End of Trial"
          },
          {
            "code": "C218546",
            "display": "ICH M11 Protocol Section 4.5 Access to Trial Intervention After End of Trial"
          },
          {
            "code": "C218547",
            "display": "ICH M11 Protocol Section 5 TRIAL POPULATION"
          },
          {
            "code": "C218548",
            "display": "ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale"
          },
          {
            "code": "C218549",
            "display": "ICH M11 Protocol Section 5.2 Inclusion Criteria"
          },
          {
            "code": "C218550",
            "display": "ICH M11 Protocol Section 5.3 Exclusion Criteria"
          },
          {
            "code": "C218551",
            "display": "ICH M11 Protocol Section 5.4 Contraception"
          },
          {
            "code": "C218552",
            "display": "ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential"
          },
          {
            "code": "C218553",
            "display": "ICH M11 Protocol Section 5.4.2 Contraception Requirements"
          },
          {
            "code": "C218554",
            "display": "ICH M11 Protocol Section 5.5 Lifestyle Restrictions"
          },
          {
            "code": "C218555",
            "display": "ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions"
          },
          {
            "code": "C218556",
            "display": "ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions"
          },
          {
            "code": "C218557",
            "display": "ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions"
          },
          {
            "code": "C218558",
            "display": "ICH M11 Protocol Section 5.5.4 Other Activity Restrictions"
          },
          {
            "code": "C218559",
            "display": "ICH M11 Protocol Section 5.6 Screen Failure and Rescreening"
          },
          {
            "code": "C218560",
            "display": "ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY"
          },
          {
            "code": "C218561",
            "display": "ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention"
          },
          {
            "code": "C218562",
            "display": "ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen"
          },
          {
            "code": "C218563",
            "display": "ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration"
          },
          {
            "code": "C218564",
            "display": "ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification"
          },
          {
            "code": "C218565",
            "display": "ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose"
          },
          {
            "code": "C218566",
            "display": "ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention"
          },
          {
            "code": "C218567",
            "display": "ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention"
          },
          {
            "code": "C218568",
            "display": "ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention"
          },
          {
            "code": "C218569",
            "display": "ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention"
          },
          {
            "code": "C218570",
            "display": "ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding"
          },
          {
            "code": "C218571",
            "display": "ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention"
          },
          {
            "code": "C218572",
            "display": "ICH M11 Protocol Section 6.7.2 Randomisation"
          },
          {
            "code": "C218573",
            "display": "ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding"
          },
          {
            "code": "C218574",
            "display": "ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site"
          },
          {
            "code": "C218575",
            "display": "ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence"
          },
          {
            "code": "C218576",
            "display": "ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention"
          },
          {
            "code": "C218577",
            "display": "ICH M11 Protocol Section 6.9.1 Background Trial Intervention"
          },
          {
            "code": "C218578",
            "display": "ICH M11 Protocol Section 6.9.2 Rescue Therapy"
          },
          {
            "code": "C218579",
            "display": "ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention"
          },
          {
            "code": "C218580",
            "display": "ICH M11 Protocol Section 6.10 Concomitant Therapy"
          },
          {
            "code": "C218581",
            "display": "ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy"
          },
          {
            "code": "C218582",
            "display": "ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy"
          },
          {
            "code": "C218583",
            "display": "ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL"
          },
          {
            "code": "C218584",
            "display": "ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants"
          },
          {
            "code": "C218585",
            "display": "ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention"
          },
          {
            "code": "C218586",
            "display": "ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention"
          },
          {
            "code": "C218587",
            "display": "ICH M11 Protocol Section 7.1.3 Rechallenge"
          },
          {
            "code": "C218588",
            "display": "ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial"
          },
          {
            "code": "C218589",
            "display": "ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up"
          },
          {
            "code": "C218590",
            "display": "ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES"
          },
          {
            "code": "C218591",
            "display": "ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations"
          },
          {
            "code": "C218592",
            "display": "ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures"
          },
          {
            "code": "C218593",
            "display": "ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures"
          },
          {
            "code": "C218594",
            "display": "ICH M11 Protocol Section 8.4 Safety Assessments and Procedures"
          },
          {
            "code": "C218595",
            "display": "ICH M11 Protocol Section 8.4.1 Physical Examination"
          },
          {
            "code": "C218596",
            "display": "ICH M11 Protocol Section 8.4.2 Vital Signs"
          },
          {
            "code": "C218597",
            "display": "ICH M11 Protocol Section 8.4.3 Electrocardiograms"
          },
          {
            "code": "C218598",
            "display": "ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments"
          },
          {
            "code": "C218599",
            "display": "ICH M11 Protocol Section 8.4.5 Pregnancy Testing"
          },
          {
            "code": "C218600",
            "display": "ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring"
          },
          {
            "code": "C218601",
            "display": "ICH M11 Protocol Section 8.5 Pharmacokinetics"
          },
          {
            "code": "C218602",
            "display": "ICH M11 Protocol Section 8.6 Biomarkers"
          },
          {
            "code": "C218603",
            "display": "ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics"
          },
          {
            "code": "C218604",
            "display": "ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers"
          },
          {
            "code": "C218605",
            "display": "ICH M11 Protocol Section 8.6.3 Other Biomarkers"
          },
          {
            "code": "C218606",
            "display": "ICH M11 Protocol Section 8.7 Immunogenicity Assessments"
          },
          {
            "code": "C218607",
            "display": "ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics"
          },
          {
            "code": "C218608",
            "display": "ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS"
          },
          {
            "code": "C218609",
            "display": "ICH M11 Protocol Section 9.1 Definitions"
          },
          {
            "code": "C218610",
            "display": "ICH M11 Protocol Section 9.1.1 Definitions of Adverse Events"
          },
          {
            "code": "C218611",
            "display": "ICH M11 Protocol Section 9.1.2 Definitions of Serious Adverse Events"
          },
          {
            "code": "C218612",
            "display": "ICH M11 Protocol Section 9.1.3 Definitions of Product Complaints"
          },
          {
            "code": "C218613",
            "display": "ICH M11 Protocol Section 9.1.3.1 Definitions of Medical Device Product Complaints"
          },
          {
            "code": "C218614",
            "display": "ICH M11 Protocol Section 9.2 Timing and Procedures for Collection and Reporting"
          },
          {
            "code": "C218615",
            "display": "ICH M11 Protocol Section 9.2.1 Timing"
          },
          {
            "code": "C218616",
            "display": "ICH M11 Protocol Section 9.2.2 Collection Procedures"
          },
          {
            "code": "C218617",
            "display": "ICH M11 Protocol Section 9.2.3 Reporting"
          },
          {
            "code": "C218618",
            "display": "ICH M11 Protocol Section 9.2.3.1 Regulatory Reporting Requirements"
          },
          {
            "code": "C218619",
            "display": "ICH M11 Protocol Section 9.2.4 Adverse Events of Special Interest"
          },
          {
            "code": "C218620",
            "display": "ICH M11 Protocol Section 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs"
          },
          {
            "code": "C218621",
            "display": "ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information"
          },
          {
            "code": "C218622",
            "display": "ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the Trial"
          },
          {
            "code": "C218623",
            "display": "ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the Trial"
          },
          {
            "code": "C218624",
            "display": "ICH M11 Protocol Section 9.4 Special Safety Situations"
          },
          {
            "code": "C218625",
            "display": "ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS"
          },
          {
            "code": "C218626",
            "display": "ICH M11 Protocol Section 10.1 General Considerations"
          },
          {
            "code": "C218627",
            "display": "ICH M11 Protocol Section 10.2 Analysis Sets"
          },
          {
            "code": "C218628",
            "display": "ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables"
          },
          {
            "code": "C218629",
            "display": "ICH M11 Protocol Section 10.4 Analyses Associated with the Primary Objective(s)"
          },
          {
            "code": "C218630",
            "display": "ICH M11 Protocol Section 10.4.1 Primary Objective"
          },
          {
            "code": "C218631",
            "display": "ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method"
          },
          {
            "code": "C218632",
            "display": "ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)"
          },
          {
            "code": "C218633",
            "display": "ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)"
          },
          {
            "code": "C218634",
            "display": "ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis"
          },
          {
            "code": "C218635",
            "display": "ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis"
          },
          {
            "code": "C218636",
            "display": "ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)"
          },
          {
            "code": "C218637",
            "display": "ICH M11 Protocol Section 10.5.1 Secondary Objective"
          },
          {
            "code": "C218638",
            "display": "ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method"
          },
          {
            "code": "C218639",
            "display": "ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)"
          },
          {
            "code": "C218640",
            "display": "ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)"
          },
          {
            "code": "C218641",
            "display": "ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis"
          },
          {
            "code": "C218642",
            "display": "ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis"
          },
          {
            "code": "C218643",
            "display": "ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)"
          },
          {
            "code": "C218644",
            "display": "ICH M11 Protocol Section 10.7 Safety Analyses"
          },
          {
            "code": "C218645",
            "display": "ICH M11 Protocol Section 10.8 Other Analyses"
          },
          {
            "code": "C218646",
            "display": "ICH M11 Protocol Section 10.9 Interim Analyses"
          },
          {
            "code": "C218647",
            "display": "ICH M11 Protocol Section 10.10 Multiplicity Adjustments"
          },
          {
            "code": "C218648",
            "display": "ICH M11 Protocol Section 10.11 Sample Size Determination"
          },
          {
            "code": "C218649",
            "display": "ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS"
          },
          {
            "code": "C218650",
            "display": "ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations"
          },
          {
            "code": "C218651",
            "display": "ICH M11 Protocol Section 11.2 Trial Oversight"
          },
          {
            "code": "C218652",
            "display": "ICH M11 Protocol Section 11.2.1 Investigator Responsibilities"
          },
          {
            "code": "C218653",
            "display": "ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities"
          },
          {
            "code": "C218654",
            "display": "ICH M11 Protocol Section 11.3 Informed Consent Process"
          },
          {
            "code": "C218655",
            "display": "ICH M11 Protocol Section 11.3.1 Informed Consent for Rescreening"
          },
          {
            "code": "C218656",
            "display": "ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research"
          },
          {
            "code": "C218657",
            "display": "ICH M11 Protocol Section 11.4 Committees"
          },
          {
            "code": "C218658",
            "display": "ICH M11 Protocol Section 11.5 Insurance and Indemnity"
          },
          {
            "code": "C218659",
            "display": "ICH M11 Protocol Section 11.6 Risk-Based Quality Management"
          },
          {
            "code": "C218660",
            "display": "ICH M11 Protocol Section 11.7 Data Governance"
          },
          {
            "code": "C218661",
            "display": "ICH M11 Protocol Section 11.8 Data Protection"
          },
          {
            "code": "C218662",
            "display": "ICH M11 Protocol Section 11.9 Source Records"
          },
          {
            "code": "C218663",
            "display": "ICH M11 Protocol Section 11.10 Protocol Deviations"
          },
          {
            "code": "C218664",
            "display": "ICH M11 Protocol Section 11.11 Early Site Closure"
          },
          {
            "code": "C218665",
            "display": "ICH M11 Protocol Section 11.12 Data Dissemination"
          },
          {
            "code": "C218666",
            "display": "ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS"
          },
          {
            "code": "C218667",
            "display": "ICH M11 Protocol Section 12.1 Clinical Laboratory Tests"
          },
          {
            "code": "C218668",
            "display": "ICH M11 Protocol Section 12.2 Country/Region-Specific Differences"
          },
          {
            "code": "C218669",
            "display": "ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s)"
          },
          {
            "code": "C218670",
            "display": "ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS"
          },
          {
            "code": "C218671",
            "display": "ICH M11 Protocol Section 14 APPENDIX: REFERENCES"
          }
        ]
      }
    ]
  }
}