udp-section-codes-vs
type: ValueSet
node role: treeRoot
id:
  v: udp-section-codes-vs
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: 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 g…
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm
    l: structuredefinition-fmm
  value: Integer
    v: 2
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
    l: structuredefinition-wg
  value: Code
    v: brr
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
    l: structuredefinition-standards-status
  value: Code
    v: trial-use
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
        l: structuredefinition-conformance-derivedFrom
      value: Canonical
        v: http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol
        l: hl7.fhir.uv.clinical-study-protocol
url:
  v: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-section-codes-vs
  l: udp-section-codes-vs
version:
  v: 1.0.0-ballot2
name:
  v: UDPSectionCodesVS
title:
  v: UDP Section Codes Value Set
status:
  v: active
experimental:
  v: false
date:
  v: 2026-04-09T17:15:23+10:00
publisher:
  v: HL7 International / Biomedical Research and Regulation
contact:
  name:
    v: HL7 International / Biomedical Research and Regulation
  telecom:
    system:
      v: url
    value:
      v: http://www.hl7.org/Special/committees/rcrim
  telecom:
    system:
      v: email
description:
  v: 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 drawn from the NCI Thesaurus and represented here in FHIR format. These codes are present in UDP to allow granularity in narrative compositions.
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 001
    display:
      v: World
copyright:
  v: Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license For more licensing information and links see: [licenses.html](licenses.html)
compose:
  include:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      l: Thesaurus.owl
    concept:
      code:
        v: C222769
      display:
        v: ICH M11 Protocol Section Title Page
    concept:
      code:
        v: C218514
      display:
        v: ICH M11 Protocol Section 1 PROTOCOL SUMMARY
    concept:
      code:
        v: C218515
      display:
        v: ICH M11 Protocol Section 1.1 Protocol Synopsis
    concept:
      code:
        v: C218516
      display:
        v: ICH M11 Protocol Section 1.1.1 Primary and Secondary Objectives and Estimands
    concept:
      code:
        v: C218517
      display:
        v: ICH M11 Protocol Section 1.1.2 Overall Design
    concept:
      code:
        v: C218518
      display:
        v: ICH M11 Protocol Section 1.2 Trial Schema
    concept:
      code:
        v: C218519
      display:
        v: ICH M11 Protocol Section 1.3 Schedule of Activities
    concept:
      code:
        v: C218520
      display:
        v: ICH M11 Protocol Section 2 INTRODUCTION
    concept:
      code:
        v: C218521
      display:
        v: ICH M11 Protocol Section 2.1 Purpose of Trial
    concept:
      code:
        v: C218522
      display:
        v: ICH M11 Protocol Section 2.2 Assessment of Risks and Benefits
    concept:
      code:
        v: C218523
      display:
        v: ICH M11 Protocol Section 2.2.1 Risk Summary and Mitigation Strategy
    concept:
      code:
        v: C218524
      display:
        v: ICH M11 Protocol Section 2.2.2 Benefit Summary
    concept:
      code:
        v: C218525
      display:
        v: ICH M11 Protocol Section 2.2.3 Overall Risk-Benefit Assessment
    concept:
      code:
        v: C218526
      display:
        v: ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS
    concept:
      code:
        v: C218527
      display:
        v: ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s)
    concept:
      code:
        v: C218528
      display:
        v: ICH M11 Protocol Section 3.1.1 Primary Objective
    concept:
      code:
        v: C218529
      display:
        v: ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s)
    concept:
      code:
        v: C218530
      display:
        v: ICH M11 Protocol Section 3.2.1 Secondary Objective
    concept:
      code:
        v: C218531
      display:
        v: ICH M11 Protocol Section 3.3 Exploratory Objective(s)
    concept:
      code:
        v: C218532
      display:
        v: ICH M11 Protocol Section 3.3.1 Exploratory Objective
    concept:
      code:
        v: C218533
      display:
        v: ICH M11 Protocol Section 4 TRIAL DESIGN
    concept:
      code:
        v: C218534
      display:
        v: ICH M11 Protocol Section 4.1 Description of Trial Design
    concept:
      code:
        v: C218535
      display:
        v: ICH M11 Protocol Section 4.1.1 Stakeholder Input into Design
    concept:
      code:
        v: C218536
      display:
        v: ICH M11 Protocol Section 4.2 Rationale for Trial Design

code:
  v: C218537
display:
  v: ICH M11 Protocol Section 4.2.1 Rationale for Estimand(s)

code:
  v: C218538
display:
  v: ICH M11 Protocol Section 4.2.2 Rationale for Intervention Model

code:
  v: C218539
display:
  v: ICH M11 Protocol Section 4.2.3 Rationale for Control Type

code:
  v: C218540
display:
  v: ICH M11 Protocol Section 4.2.4 Rationale for Trial Duration

code:
  v: C218541
display:
  v: ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial Design

code:
  v: C218542
display:
  v: ICH M11 Protocol Section 4.2.6 Rationale for Interim Analysis

code:
  v: C218543
display:
  v: ICH M11 Protocol Section 4.2.7 Rationale for Other Trial Design Aspects

code:
  v: C218544
display:
  v: ICH M11 Protocol Section 4.3 Trial Stopping Rules

code:
  v: C218545
display:
  v: ICH M11 Protocol Section 4.4 Start of Trial and End of Trial

code:
  v: C218546
display:
  v: ICH M11 Protocol Section 4.5 Access to Trial Intervention After End of Trial

code:
  v: C218547
display:
  v: ICH M11 Protocol Section 5 TRIAL POPULATION

code:
  v: C218548
display:
  v: ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale

code:
  v: C218549
display:
  v: ICH M11 Protocol Section 5.2 Inclusion Criteria

code:
  v: C218550
display:
  v: ICH M11 Protocol Section 5.3 Exclusion Criteria

code:
  v: C218551
display:
  v: ICH M11 Protocol Section 5.4 Contraception

code:
  v: C218552
display:
  v: ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential

code:
  v: C218553
display:
  v: ICH M11 Protocol Section 5.4.2 Contraception Requirements

code:
  v: C218554
display:
  v: ICH M11 Protocol Section 5.5 Lifestyle Restrictions

code:
  v: C218555
display:
  v: ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions

code:
  v: C218556
display:
  v: ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions

code:
  v: C218557
display:
  v: ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions

code:
  v: C218558
display:
  v: ICH M11 Protocol Section 5.5.4 Other Activity Restrictions

code:
  v: C218559
display:
  v: ICH M11 Protocol Section 5.6 Screen Failure and Rescreening

code:
  v: C218560
display:
  v: ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY

code:
  v: C218561
display:
  v: ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention

code:
  v: C218562
display:
  v: ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen

code:
  v: C218563
display:
  v: ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration

code:
  v: C218564
display:
  v: ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification

code:
  v: C218565
display:
  v: ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose

code:
  v: C218566
display:
  v: ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention

code:
  v: C218567
display:
  v: ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention

code:
  v: C218568
display:
  v: ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention

code:
  v: C218569
display:
  v: ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention

code:
  v: C218570
display:
  v: ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding

code:
  v: C218571
display:
  v: ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention

code:
  v: C218572
display:
  v: ICH M11 Protocol Section 6.7.2 Randomisation

code:
  v: C218573
display:
  v: ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding

code:
  v: C218574
display:
  v: ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site

code:
  v: C218575
display:
  v: ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence

code:
  v: C218576
display:
  v: ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention

code:
  v: C218577
display:
  v: ICH M11 Protocol Section 6.9.1 Background Trial Intervention

code:
  v: C218578
display:
  v: ICH M11 Protocol Section 6.9.2 Rescue Therapy

code:
  v: C218579
display:
  v: ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention

code:
  v: C218580
display:
  v: ICH M11 Protocol Section 6.10 Concomitant Therapy

code:
  v: C218581
display:
  v: ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy

code:
  v: C218582
display:
  v: ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy

code:
  v: C218583
display:
  v: ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL

code:
  v: C218584
display:
  v: ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants

code:
  v: C218585
display:
  v: ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention

code:
  v: C218586
display:
  v: ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention

code:
  v: C218587
display:
  v: ICH M11 Protocol Section 7.1.3 Rechallenge

code:
  v: C218588
display:
  v: ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial

code:
  v: C218589
display:
  v: ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up

code:
  v: C218590
display:
  v: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES

code:
  v: C218591
display:
  v: ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations

code:
  v: C218592
display:
  v: ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures

code:
  v: C218593
display:
  v: ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures

code:
  v: C218594
display:
  v: ICH M11 Protocol Section 8.4 Safety Assessments and Procedures

code:
  v: C218595
display:
  v: ICH M11 Protocol Section 8.4.1 Physical Examination

code:
  v: C218596
display:
  v: ICH M11 Protocol Section 8.4.2 Vital Signs

code:
  v: C218597
display:
  v: ICH M11 Protocol Section 8.4.3 Electrocardiograms

code:
  v: C218598
display:
  v: ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments

code:
  v: C218599
display:
  v: ICH M11 Protocol Section 8.4.5 Pregnancy Testing

code:
  v: C218600
display:
  v: ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring

code:
  v: C218601
display:
  v: ICH M11 Protocol Section 8.5 Pharmacokinetics

code:
  v: C218602
display:
  v: ICH M11 Protocol Section 8.6 Biomarkers

code:
  v: C218603
display:
  v: ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics

code:
  v: C218604
display:
  v: ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers

code:
  v: C218605
display:
  v: ICH M11 Protocol Section 8.6.3 Other Biomarkers

code:
  v: C218606
display:
  v: ICH M11 Protocol Section 8.7 Immunogenicity Assessments

code:
  v: C218607
display:
  v: ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics

code:
  v: C218608
display:
  v: ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS

code:
  v: C218609
display:
  v: ICH M11 Protocol Section 9.1 Definitions

code:
  v: C218610
display:
  v: ICH M11 Protocol Section 9.1.1 Definitions of Adverse Events

code:
  v: C218611
display:
  v: ICH M11 Protocol Section 9.1.2 Definitions of Serious Adverse Events

code:
  v: C218612
display:
  v: ICH M11 Protocol Section 9.1.3 Definitions of Product Complaints

code:
  v: C218613
display:
  v: ICH M11 Protocol Section 9.1.3.1 Definitions of Medical Device Product Complaints

code:
  v: C218614
display:
  v: ICH M11 Protocol Section 9.2 Timing and Procedures for Collection and Reporting

code:
  v: C218615
display:
  v: ICH M11 Protocol Section 9.2.1 Timing

code:
  v: C218616
display:
  v: ICH M11 Protocol Section 9.2.2 Collection Procedures

code:
  v: C218617
display:
  v: ICH M11 Protocol Section 9.2.3 Reporting

code:
  v: C218618
display:
  v: ICH M11 Protocol Section 9.2.3.1 Regulatory Reporting Requirements

code:
  v: C218619
display:
  v: ICH M11 Protocol Section 9.2.4 Adverse Events of Special Interest

code:
  v: C218620
display:
  v: ICH M11 Protocol Section 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs

code:
  v: C218621
display:
  v: ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information

code:
  v: C218622
display:
  v: ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the Trial

code:
  v: C218623
display:
  v: ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the Trial

code:
  v: C218624
display:
  v: ICH M11 Protocol Section 9.4 Special Safety Situations

code:
  v: C218625
display:
  v: ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS

code:
  v: C218626
display:
  v: ICH M11 Protocol Section 10.1 General Considerations

code:
  v: C218627
display:
  v: ICH M11 Protocol Section 10.2 Analysis Sets

code:
  v: C218628
display:
  v: ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables

code:
  v: C218629
display:
  v: ICH M11 Protocol Section 10.4 Analyses Associated with the Primary Objective(s)

code:
  v: C218630
display:
  v: ICH M11 Protocol Section 10.4.1 Primary Objective

code:
  v: C218631
display:
  v: ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method

code:
  v: C218632
display:
  v: ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)

code:
  v: C218633
display:
  v: ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)

code:
  v: C218634
display:
  v: ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis

code:
  v: C218635
display:
  v: ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis

code:
  v: C218636
display:
  v: ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)

code:
  v: C218637
display:
  v: ICH M11 Protocol Section 10.5.1 Secondary Objective

code:
  v: C218638
display:
  v: ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method

code:
  v: C218639
display:
  v: ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)

code:
  v: C218640
display:
  v: ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)

code:
  v: C218641
display:
  v: ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis

code:
  v: C218642
display:
  v: ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis

code:
  v: C218643
display:
  v: ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)

code:
  v: C218644
display:
  v: ICH M11 Protocol Section 10.7 Safety Analyses

code:
  v: C218645
display:
  v: ICH M11 Protocol Section 10.8 Other Analyses

code:
  v: C218646
display:
  v: ICH M11 Protocol Section 10.9 Interim Analyses

code:
  v: C218647
display:
  v: ICH M11 Protocol Section 10.10 Multiplicity Adjustments

code:
  v: C218648
display:
  v: ICH M11 Protocol Section 10.11 Sample Size Determination

code:
  v: C218649
display:
  v: ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS

code:
  v: C218650
display:
  v: ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations

code:
  v: C218651
display:
  v: ICH M11 Protocol Section 11.2 Trial Oversight

code:
  v: C218652
display:
  v: ICH M11 Protocol Section 11.2.1 Investigator Responsibilities

code:
  v: C218653
display:
  v: ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities

code:
  v: C218654
display:
  v: ICH M11 Protocol Section 11.3 Informed Consent Process

code:
  v: C218655
display:
  v: ICH M11 Protocol Section 11.3.1 Informed Consent for Rescreening

code:
  v: C218656
display:
  v: ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research

code:
  v: C218657
display:
  v: ICH M11 Protocol Section 11.4 Committees

code:
  v: C218658
display:
  v: ICH M11 Protocol Section 11.5 Insurance and Indemnity

code:
  v: C218659
display:
  v: ICH M11 Protocol Section 11.6 Risk-Based Quality Management

code:
  v: C218660
display:
  v: ICH M11 Protocol Section 11.7 Data Governance

code:
  v: C218661
display:
  v: ICH M11 Protocol Section 11.8 Data Protection

code:
  v: C218662
display:
  v: ICH M11 Protocol Section 11.9 Source Records

code:
  v: C218663
display:
  v: ICH M11 Protocol Section 11.10 Protocol Deviations

code:
  v: C218664
display:
  v: ICH M11 Protocol Section 11.11 Early Site Closure

code:
  v: C218665
display:
  v: ICH M11 Protocol Section 11.12 Data Dissemination

code:
  v: C218666
display:
  v: ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS

code:
  v: C218667
display:
  v: ICH M11 Protocol Section 12.1 Clinical Laboratory Tests

code:
  v: C218668
display:
  v: ICH M11 Protocol Section 12.2 Country/Region-Specific Differences

code:
  v: C218669
display:
  v: ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s)

code:
  v: C218670
display:
  v: ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS

code:
  v: C218671
display:
  v: ICH M11 Protocol Section 14 APPENDIX: REFERENCES