Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## : UDP Section Codes Value Set

Page standards status: Trial-use | Maturity Level: 2

Raw xml | Download

    <ValueSet xmlns="http://hl7.org/fhir">
      <id value="udp-section-codes-vs"/>
      <language value="en"/>
      <text>
        <status value="extensions"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet udp-section-codes-vs</b></p><a name="udp-section-codes-vs"> </a><a name="hcudp-section-codes-vs"> </a><ul><li>Include these codes as defined in <a href="CodeSystem-ncit-cs.html"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><span title="Version is not explicitly stated, which means it is fixed to the version provided in this specification"> version &#x1F4E6;1.0.0-ballot2</span><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C222769">C222769</a></td><td>ICH M11 Protocol Section Title Page</td><td>Title Page Section of the ICH M11 Protocol standard, Title Page.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218514">C218514</a></td><td>ICH M11 Protocol Section 1 PROTOCOL SUMMARY</td><td>The title of section 1 of the ICH M11 protocol guideline: PROTOCOL SUMMARY.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218515">C218515</a></td><td>ICH M11 Protocol Section 1.1 Protocol Synopsis</td><td>The title of section 1.1 of the ICH M11 protocol guideline: Protocol Synopsis.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218516">C218516</a></td><td>ICH M11 Protocol Section 1.1.1 Primary and Secondary Objectives and Estimands</td><td>The title of section 1.1.1 of the ICH M11 protocol guideline: Primary and Secondary Objectives and Estimands.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218517">C218517</a></td><td>ICH M11 Protocol Section 1.1.2 Overall Design</td><td>The title of section 1.1.2 of the ICH M11 protocol guideline: Overall Design.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218518">C218518</a></td><td>ICH M11 Protocol Section 1.2 Trial Schema</td><td>The title of section 1.2 of the ICH M11 protocol guideline: Trial Schema.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218519">C218519</a></td><td>ICH M11 Protocol Section 1.3 Schedule of Activities</td><td>The title of section 1.3 of the ICH M11 protocol guideline: Schedule of Activities.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218520">C218520</a></td><td>ICH M11 Protocol Section 2 INTRODUCTION</td><td>The title of section 2 of the ICH M11 protocol guideline: INTRODUCTION.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218521">C218521</a></td><td>ICH M11 Protocol Section 2.1 Purpose of Trial</td><td>The title of section 2.1 of the ICH M11 protocol guideline: Purpose of Trial.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218522">C218522</a></td><td>ICH M11 Protocol Section 2.2 Assessment of Risks and Benefits</td><td>The title of section 2.2 of the ICH M11 protocol guideline: Assessment of Risks and Benefits.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218523">C218523</a></td><td>ICH M11 Protocol Section 2.2.1 Risk Summary and Mitigation Strategy</td><td>The title of section 2.2.2 of the ICH M11 protocol guideline: Risk Summary and Mitigation Strategy.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218524">C218524</a></td><td>ICH M11 Protocol Section 2.2.2 Benefit Summary</td><td>The title of section 2.2.1 of the ICH M11 protocol guideline: Benefit Summary.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218525">C218525</a></td><td>ICH M11 Protocol Section 2.2.3 Overall Risk-Benefit Assessment</td><td>The title of section 2.2.3 of the ICH M11 protocol guideline: Overall Risk-Benefit Assessment.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218526">C218526</a></td><td>ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS</td><td>The title of section 3 of the ICH M11 protocol guideline: TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218527">C218527</a></td><td>ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s)</td><td>The title of section 3.1 of the ICH M11 protocol guideline: Primary Objective(s) and Associated Estimand(s).</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218528">C218528</a></td><td>ICH M11 Protocol Section 3.1.1 Primary Objective</td><td>The title of section 3.1.1 of the ICH M11 protocol guideline: Primary Objective.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218529">C218529</a></td><td>ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s)</td><td>The title of section 3.2 of the ICH M11 protocol guideline: Secondary Objective(s) and Associated Estimand(s).</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218530">C218530</a></td><td>ICH M11 Protocol Section 3.2.1 Secondary Objective</td><td>The title of section 3.2.1 of the ICH M11 protocol guideline: Secondary Objective.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218531">C218531</a></td><td>ICH M11 Protocol Section 3.3 Exploratory Objective(s)</td><td>The title of section 3.3 of the ICH M11 protocol guideline: Exploratory Objective(s).</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218532">C218532</a></td><td>ICH M11 Protocol Section 3.3.1 Exploratory Objective</td><td>The title of section 3.3.1 of the ICH M11 protocol guideline: Exploratory Objective.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218533">C218533</a></td><td>ICH M11 Protocol Section 4 TRIAL DESIGN</td><td>The title of section 4 of the ICH M11 protocol guideline: TRIAL DESIGN.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218534">C218534</a></td><td>ICH M11 Protocol Section 4.1 Description of Trial Design</td><td>The title of section 4.1 of the ICH M11 protocol guideline: Description of Trial Design.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218535">C218535</a></td><td>ICH M11 Protocol Section 4.1.1 Stakeholder Input into Design</td><td>The title of section 4.1.1 of the ICH M11 protocol guideline: Stakeholder Input into Design.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218536">C218536</a></td><td>ICH M11 Protocol Section 4.2 Rationale for Trial Design</td><td>The title of section 4.2 of the ICH M11 protocol guideline: Rationale for Trial Design.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218537">C218537</a></td><td>ICH M11 Protocol Section 4.2.1 Rationale for Estimand(s)</td><td>The title of section 4.2.1 of the ICH M11 protocol guideline: Rationale for Estimand(s).</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218538">C218538</a></td><td>ICH M11 Protocol Section 4.2.2 Rationale for Intervention Model</td><td>The title of section 4.2.2 of the ICH M11 protocol guideline: Rationale for Intervention Model.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218539">C218539</a></td><td>ICH M11 Protocol Section 4.2.3 Rationale for Control Type</td><td>The title of section 4.2.3 of the ICH M11 protocol guideline: Rationale for Control Type.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218540">C218540</a></td><td>ICH M11 Protocol Section 4.2.4 Rationale for Trial Duration</td><td>The title of section 4.2.4 of the ICH M11 protocol guideline: Rationale for Trial Duration.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218541">C218541</a></td><td>ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial Design</td><td>The title of section 4.2.5 of the ICH M11 protocol guideline: Rationale for Adaptive or Novel Trial Design.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218542">C218542</a></td><td>ICH M11 Protocol Section 4.2.6 Rationale for Interim Analysis</td><td>The title of section 4.2.6 of the ICH M11 protocol guideline: Rationale for Interim Analysis.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218543">C218543</a></td><td>ICH M11 Protocol Section 4.2.7 Rationale for Other Trial Design Aspects</td><td>The title of section 4.2.7 of the ICH M11 protocol guideline: Rationale for Other Trial Design Aspects.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218544">C218544</a></td><td>ICH M11 Protocol Section 4.3 Trial Stopping Rules</td><td>The title of section 4.3 of the ICH M11 protocol guideline: Trial Stopping Rules.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218545">C218545</a></td><td>ICH M11 Protocol Section 4.4 Start of Trial and End of Trial</td><td>The title of section 4.4 of the ICH M11 protocol guideline: Start of Trial and End of Trial.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218546">C218546</a></td><td>ICH M11 Protocol Section 4.5 Access to Trial Intervention After End of Trial</td><td>The title of section 4.5 of the ICH M11 protocol guideline: Access to Trial Intervention After End of Trial.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218547">C218547</a></td><td>ICH M11 Protocol Section 5 TRIAL POPULATION</td><td>The title of section 5 of the ICH M11 protocol guideline: TRIAL POPULATION.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218548">C218548</a></td><td>ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale</td><td>The title of section 5.1 of the ICH M11 protocol guideline: Description of Trial Population and Rationale.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218549">C218549</a></td><td>ICH M11 Protocol Section 5.2 Inclusion Criteria</td><td>The title of section 5.2 of the ICH M11 protocol guideline: Inclusion Criteria.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218550">C218550</a></td><td>ICH M11 Protocol Section 5.3 Exclusion Criteria</td><td>The title of section 5.3 of the ICH M11 protocol guideline: Exclusion Criteria.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218551">C218551</a></td><td>ICH M11 Protocol Section 5.4 Contraception</td><td>The title of section 5.4 of the ICH M11 protocol guideline: Contraception.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218552">C218552</a></td><td>ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential</td><td>The title of section 5.4.1 of the ICH M11 protocol guideline: Definitions Related to Childbearing Potential.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218553">C218553</a></td><td>ICH M11 Protocol Section 5.4.2 Contraception Requirements</td><td>The title of section 5.4.2 of the ICH M11 protocol guideline: Contraception Requirements.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218554">C218554</a></td><td>ICH M11 Protocol Section 5.5 Lifestyle Restrictions</td><td>The title of section 5.5 of the ICH M11 protocol guideline: Lifestyle Restrictions.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218555">C218555</a></td><td>ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions</td><td>The title of section 5.5.1 of the ICH M11 protocol guideline: Meals and Dietary Restrictions.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218556">C218556</a></td><td>ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions</td><td>The title of section 5.5.2 of the ICH M11 protocol guideline: Caffeine, Alcohol, Tobacco, and Other Restrictions.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218557">C218557</a></td><td>ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions</td><td>The title of section 5.5.3 of the ICH M11 protocol guideline: Physical Activity Restrictions.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218558">C218558</a></td><td>ICH M11 Protocol Section 5.5.4 Other Activity Restrictions</td><td>The title of section 5.5.4 of the ICH M11 protocol guideline: Other Activity Restrictions.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218559">C218559</a></td><td>ICH M11 Protocol Section 5.6 Screen Failure and Rescreening</td><td>The title of section 5.6 of the ICH M11 protocol guideline: Screen Failure and Rescreening.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218560">C218560</a></td><td>ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY</td><td>The title of section 6 of the ICH M11 protocol guideline: TRIAL INTERVENTION AND CONCOMITANT THERAPY.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218561">C218561</a></td><td>ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention</td><td>The title of section 6.1 of the ICH M11 protocol guideline: Description of Investigational Trial Intervention.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218562">C218562</a></td><td>ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen</td><td>The title of section 6.2 of the ICH M11 protocol guideline: Rationale for Investigational Trial Intervention Dose and Regimen.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218563">C218563</a></td><td>ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration</td><td>The title of section 6.3 of the ICH M11 protocol guideline: Investigational Trial Intervention Administration.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218564">C218564</a></td><td>ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification</td><td>The title of section 6.4 of the ICH M11 protocol guideline: Investigational Trial Intervention Dose Modification.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218565">C218565</a></td><td>ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose</td><td>The title of section 6.5 of the ICH M11 protocol guideline: Management of Investigational Trial Intervention Overdose.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218566">C218566</a></td><td>ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention</td><td>The title of section 6.6 of the ICH M11 protocol guideline: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218567">C218567</a></td><td>ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention</td><td>The title of section 6.6.1 of the ICH M11 protocol guideline: Preparation of Investigational Trial Intervention.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218568">C218568</a></td><td>ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention</td><td>The title of section 6.6.2 of the ICH M11 protocol guideline: Storage and Handling of Investigational Trial Intervention.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218569">C218569</a></td><td>ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention</td><td>The title of section 6.6.3 of the ICH M11 protocol guideline: Accountability of Investigational Trial Intervention.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218570">C218570</a></td><td>ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding</td><td>The title of section 6.7 of the ICH M11 protocol guideline: Investigational Trial Intervention Assignment, Randomisation and Blinding.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218571">C218571</a></td><td>ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention</td><td>The title of section 6.7.1 of the ICH M11 protocol guideline: Participant Assignment to Investigational Trial Intervention.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218572">C218572</a></td><td>ICH M11 Protocol Section 6.7.2 Randomisation</td><td>The title of section 6.7.2 of the ICH M11 protocol guideline: Randomisation.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218573">C218573</a></td><td>ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding</td><td>The title of section 6.7.3 of the ICH M11 protocol guideline: Measures to Maintain Blinding.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218574">C218574</a></td><td>ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site</td><td>The title of section 6.7.4 of the ICH M11 protocol guideline: Emergency Unblinding at the Site.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218575">C218575</a></td><td>ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence</td><td>The title of section 6.8 of the ICH M11 protocol guideline: Investigational Trial Intervention Adherence.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218576">C218576</a></td><td>ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention</td><td>The title of section 6.9 of the ICH M11 protocol guideline: Description of Noninvestigational Trial Intervention.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218577">C218577</a></td><td>ICH M11 Protocol Section 6.9.1 Background Trial Intervention</td><td>The title of section 6.9.1 of the ICH M11 protocol guideline: Background Trial Intervention.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218578">C218578</a></td><td>ICH M11 Protocol Section 6.9.2 Rescue Therapy</td><td>The title of section 6.9.2 of the ICH M11 protocol guideline: Rescue Therapy.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218579">C218579</a></td><td>ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention</td><td>The title of section 6.9.3 of the ICH M11 protocol guideline: Other Noninvestigational Trial Intervention.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218580">C218580</a></td><td>ICH M11 Protocol Section 6.10 Concomitant Therapy</td><td>The title of section 6.10 of the ICH M11 protocol guideline: Concomitant Therapy.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218581">C218581</a></td><td>ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy</td><td>The title of section 6.10.1 of the ICH M11 protocol guideline: Prohibited Concomitant Therapy.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218582">C218582</a></td><td>ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy</td><td>The title of section 6.10.2 of the ICH M11 protocol guideline: Permitted Concomitant Therapy.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218583">C218583</a></td><td>ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL</td><td>The title of section 7 of the ICH M11 protocol guideline: PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218584">C218584</a></td><td>ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants</td><td>The title of section 7.1 of the ICH M11 protocol guideline: Discontinuation of Trial Intervention for Individual Participants.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218585">C218585</a></td><td>ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention</td><td>The title of section 7.1.1 of the ICH M11 protocol guideline: Permanent Discontinuation of Trial Intervention.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218586">C218586</a></td><td>ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention</td><td>The title of section 7.1.2 of the ICH M11 protocol guideline: Temporary Discontinuation of Trial Intervention.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218587">C218587</a></td><td>ICH M11 Protocol Section 7.1.3 Rechallenge</td><td>The title of section 7.1.3 of the ICH M11 protocol guideline: Rechallenge.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218588">C218588</a></td><td>ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial</td><td>The title of section 7.2 of the ICH M11 protocol guideline: Participant Discontinuation or Withdrawal from the Trial.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218589">C218589</a></td><td>ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up</td><td>The title of section 7.3 of the ICH M11 protocol guideline: Management of Loss to Follow-Up.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218590">C218590</a></td><td>ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES</td><td>The title of section 8 of the ICH M11 protocol guideline: TRIAL ASSESSMENTS AND PROCEDURES.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218591">C218591</a></td><td>ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations</td><td>The title of section 8.1 of the ICH M11 protocol guideline: Trial Assessments and Procedures Considerations.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218592">C218592</a></td><td>ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures</td><td>The title of section 8.2 of the ICH M11 protocol guideline: Screening/Baseline Assessments and Procedures.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218593">C218593</a></td><td>ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures</td><td>The title of section 8.3 of the ICH M11 protocol guideline: Efficacy Assessments and Procedures.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218594">C218594</a></td><td>ICH M11 Protocol Section 8.4 Safety Assessments and Procedures</td><td>The title of section 8.4 of the ICH M11 protocol guideline: Safety Assessments and Procedures.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218595">C218595</a></td><td>ICH M11 Protocol Section 8.4.1 Physical Examination</td><td>The title of section 8.4.1 of the ICH M11 protocol guideline: Physical Examination.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218596">C218596</a></td><td>ICH M11 Protocol Section 8.4.2 Vital Signs</td><td>The title of section 8.4.2 of the ICH M11 protocol guideline: Vital Signs.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218597">C218597</a></td><td>ICH M11 Protocol Section 8.4.3 Electrocardiograms</td><td>The title of section 8.4.3 of the ICH M11 protocol guideline: Electrocardiograms.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218598">C218598</a></td><td>ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments</td><td>The title of section 8.4.4 of the ICH M11 protocol guideline: Clinical Laboratory Assessments.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218599">C218599</a></td><td>ICH M11 Protocol Section 8.4.5 Pregnancy Testing</td><td>The title of section 8.4.5 of the ICH M11 protocol guideline: Pregnancy Testing.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218600">C218600</a></td><td>ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring</td><td>The title of section 8.4.6 of the ICH M11 protocol guideline: Suicidal Ideation and Behaviour Risk Monitoring.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218601">C218601</a></td><td>ICH M11 Protocol Section 8.5 Pharmacokinetics</td><td>The title of section 8.5 of the ICH M11 protocol guideline: Pharmacokinetics.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218602">C218602</a></td><td>ICH M11 Protocol Section 8.6 Biomarkers</td><td>The title of section 8.6 of the ICH M11 protocol guideline: Biomarkers.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218603">C218603</a></td><td>ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics</td><td>The title of section 8.6.1 of the ICH M11 protocol guideline: Genetics, Genomics, Pharmacogenetics and Pharmacogenomics.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218604">C218604</a></td><td>ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers</td><td>The title of section 8.6.2 of the ICH M11 protocol guideline: Pharmacodynamic Biomarkers.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218605">C218605</a></td><td>ICH M11 Protocol Section 8.6.3 Other Biomarkers</td><td>The title of section 8.6.3 of the ICH M11 protocol guideline: Other Biomarkers.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218606">C218606</a></td><td>ICH M11 Protocol Section 8.7 Immunogenicity Assessments</td><td>The title of section 8.7 of the ICH M11 protocol guideline: Immunogenicity Assessments.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218607">C218607</a></td><td>ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics</td><td>The title of section 8.8 of the ICH M11 protocol guideline: Medical Resource Utilisation and Health Economics.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218608">C218608</a></td><td>ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS</td><td>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.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218609">C218609</a></td><td>ICH M11 Protocol Section 9.1 Definitions</td><td>The title of section 9.1 of the ICH M11 protocol guideline: Definitions.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218610">C218610</a></td><td>ICH M11 Protocol Section 9.1.1 Definitions of Adverse Events</td><td>The title of section 9.1.1 of the ICH M11 protocol guideline: Definitions of Adverse Events.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218611">C218611</a></td><td>ICH M11 Protocol Section 9.1.2 Definitions of Serious Adverse Events</td><td>The title of section 9.1.2 of the ICH M11 protocol guideline: Definitions of Serious Adverse Events.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218612">C218612</a></td><td>ICH M11 Protocol Section 9.1.3 Definitions of Product Complaints</td><td>The title of section 9.1.3 of the ICH M11 protocol guideline: Definitions of Product Complaints.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218613">C218613</a></td><td>ICH M11 Protocol Section 9.1.3.1 Definitions of Medical Device Product Complaints</td><td>The title of section 9.1.3.1 of the ICH M11 protocol guideline: Definitions of Medical Device Product Complaints.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218614">C218614</a></td><td>ICH M11 Protocol Section 9.2 Timing and Procedures for Collection and Reporting</td><td>The title of section 9.2 of the ICH M11 protocol guideline: Timing and Procedures for Collection and Reporting.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218615">C218615</a></td><td>ICH M11 Protocol Section 9.2.1 Timing</td><td>The title of section 9.2.1 of the ICH M11 protocol guideline: Timing.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218616">C218616</a></td><td>ICH M11 Protocol Section 9.2.2 Collection Procedures</td><td>The title of section 9.2.2 of the ICH M11 protocol guideline: Collection Procedures.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218617">C218617</a></td><td>ICH M11 Protocol Section 9.2.3 Reporting</td><td>The title of section 9.2.3 of the ICH M11 protocol guideline: Reporting.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218618">C218618</a></td><td>ICH M11 Protocol Section 9.2.3.1 Regulatory Reporting Requirements</td><td>The title of section 9.2.3.1 of the ICH M11 protocol guideline: Regulatory Reporting Requirements.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218619">C218619</a></td><td>ICH M11 Protocol Section 9.2.4 Adverse Events of Special Interest</td><td>The title of section 9.2.4 of the ICH M11 protocol guideline: Adverse Events of Special Interest.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218620">C218620</a></td><td>ICH M11 Protocol Section 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs</td><td>The title of section 9.2.5 of the ICH M11 protocol guideline: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218621">C218621</a></td><td>ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information</td><td>The title of section 9.3 of the ICH M11 protocol guideline: Pregnancy and Postpartum Information.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218622">C218622</a></td><td>ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the Trial</td><td>The title of section 9.3.1 of the ICH M11 protocol guideline: Participants Who Become Pregnant During the Trial.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218623">C218623</a></td><td>ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the Trial</td><td>The title of section 9.3.2 of the ICH M11 protocol guideline: Participants Whose Partners Become Pregnant During the Trial.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218624">C218624</a></td><td>ICH M11 Protocol Section 9.4 Special Safety Situations</td><td>The title of section 9.4 of the ICH M11 protocol guideline: Special Safety Situations.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218625">C218625</a></td><td>ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS</td><td>The title of section 10 of the ICH M11 protocol guideline: STATISTICAL CONSIDERATIONS.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218626">C218626</a></td><td>ICH M11 Protocol Section 10.1 General Considerations</td><td>The title of section 10.1 of the ICH M11 protocol guideline: General Considerations.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218627">C218627</a></td><td>ICH M11 Protocol Section 10.2 Analysis Sets</td><td>The title of section 10.2 of the ICH M11 protocol guideline: Analysis Sets.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218628">C218628</a></td><td>ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables</td><td>The title of section 10.3 of the ICH M11 protocol guideline: Analyses of Demographics and Other Baseline Variables.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218629">C218629</a></td><td>ICH M11 Protocol Section 10.4 Analyses Associated with the Primary Objective(s)</td><td>The title of section 10.4 of the ICH M11 protocol guideline: Analyses Associated with the Primary Objective(s).</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218630">C218630</a></td><td>ICH M11 Protocol Section 10.4.1 Primary Objective</td><td>The title of section 10.4.1 of the ICH M11 protocol guideline: Primary Objective.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218631">C218631</a></td><td>ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method</td><td>The title of section 10.4.1.1 of the ICH M11 protocol guideline: Statistical Analysis Method.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218632">C218632</a></td><td>ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)</td><td>The title of section 10.4.1.2 of the ICH M11 protocol guideline: Handling of Data in Relation to Primary Estimand(s).</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218633">C218633</a></td><td>ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)</td><td>The title of section 10.4.1.3 of the ICH M11 protocol guideline: Handling of Missing Data in Relation to Primary Estimand(s)</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218634">C218634</a></td><td>ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis</td><td>The title of section 10.4.1.4 of the ICH M11 protocol guideline: Sensitivity Analysis.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218635">C218635</a></td><td>ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis</td><td>The title of section 10.4.1.5 of the ICH M11 protocol guideline: Supplementary Analysis.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218636">C218636</a></td><td>ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)</td><td>The title of section 10.5 of the ICH M11 protocol guideline: Analyses Associated with the Secondary Objective(s).</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218637">C218637</a></td><td>ICH M11 Protocol Section 10.5.1 Secondary Objective</td><td>The title of section 10.5.1 of the ICH M11 protocol guideline: Secondary Objective.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218638">C218638</a></td><td>ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method</td><td>The title of section 10.5.1.1 of the ICH M11 protocol guideline: Statistical Analysis Method.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218639">C218639</a></td><td>ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)</td><td>The title of section 10.5.1.2 of the ICH M11 protocol guideline: Handling of Data in Relation to Secondary Estimand(s).</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218640">C218640</a></td><td>ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)</td><td>The title of section 10.5.1.3 of the ICH M11 protocol guideline: Handling of Missing Data in Relation to Secondary Estimand(s).</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218641">C218641</a></td><td>ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis</td><td>The title of section 10.5.1.4 of the ICH M11 protocol guideline: Sensitivity Analysis.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218642">C218642</a></td><td>ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis</td><td>The title of section 10.5.1.5 of the ICH M11 protocol guideline: Supplementary Analysis.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218643">C218643</a></td><td>ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)</td><td>The title of section 10.6 of the ICH M11 protocol guideline: Analyses Associated with the Exploratory Objective(s).</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218644">C218644</a></td><td>ICH M11 Protocol Section 10.7 Safety Analyses</td><td>The title of section 10.7 of the ICH M11 protocol guideline: Safety Analyses.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218645">C218645</a></td><td>ICH M11 Protocol Section 10.8 Other Analyses</td><td>The title of section 10.8 of the ICH M11 protocol guideline: Other Analyses.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218646">C218646</a></td><td>ICH M11 Protocol Section 10.9 Interim Analyses</td><td>The title of section 10.9 of the ICH M11 protocol guideline: Interim Analyses.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218647">C218647</a></td><td>ICH M11 Protocol Section 10.10 Multiplicity Adjustments</td><td>The title of section 10.10 of the ICH M11 protocol guideline: Multiplicity Adjustments.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218648">C218648</a></td><td>ICH M11 Protocol Section 10.11 Sample Size Determination</td><td>The title of section 10.11 of the ICH M11 protocol guideline: Sample Size Determination.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218649">C218649</a></td><td>ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS</td><td>The title of section 11 of the ICH M11 protocol guideline: TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218650">C218650</a></td><td>ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations</td><td>The title of section 11.1 of the ICH M11 protocol guideline: Regulatory and Ethical Considerations.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218651">C218651</a></td><td>ICH M11 Protocol Section 11.2 Trial Oversight</td><td>The title of section 11.2 of the ICH M11 protocol guideline: Trial Oversight.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218652">C218652</a></td><td>ICH M11 Protocol Section 11.2.1 Investigator Responsibilities</td><td>The title of section 11.2.1 of the ICH M11 protocol guideline: Investigator Responsibilities.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218653">C218653</a></td><td>ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities</td><td>The title of section 11.2.2 of the ICH M11 protocol guideline: Sponsor Responsibilities.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218654">C218654</a></td><td>ICH M11 Protocol Section 11.3 Informed Consent Process</td><td>The title of section 11.3 of the ICH M11 protocol guideline: Informed Consent Process.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218655">C218655</a></td><td>ICH M11 Protocol Section 11.3.1 Informed Consent for Rescreening</td><td>The title of section 11.3.1 of the ICH M11 protocol guideline: Informed Consent for Rescreening.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218656">C218656</a></td><td>ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research</td><td>The title of section 11.3.2 of the ICH M11 protocol guideline: Informed Consent for Use of Remaining Samples in Exploratory Research.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218657">C218657</a></td><td>ICH M11 Protocol Section 11.4 Committees</td><td>The title of section 11.4 of the ICH M11 protocol guideline: Committees.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218658">C218658</a></td><td>ICH M11 Protocol Section 11.5 Insurance and Indemnity</td><td>The title of section 11.5 of the ICH M11 protocol guideline: Insurance and Indemnity.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218659">C218659</a></td><td>ICH M11 Protocol Section 11.6 Risk-Based Quality Management</td><td>The title of section 11.6 of the ICH M11 protocol guideline: Risk-Based Quality Management.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218660">C218660</a></td><td>ICH M11 Protocol Section 11.7 Data Governance</td><td>The title of section 11.7 of the ICH M11 protocol guideline: Data Governance.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218661">C218661</a></td><td>ICH M11 Protocol Section 11.8 Data Protection</td><td>The title of section 11.8 of the ICH M11 protocol guideline: Data Protection.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218662">C218662</a></td><td>ICH M11 Protocol Section 11.9 Source Records</td><td>The title of section 11.9 of the ICH M11 protocol guideline: Source Records.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218663">C218663</a></td><td>ICH M11 Protocol Section 11.10 Protocol Deviations</td><td>The title of section 11.10 of the ICH M11 protocol guideline: Protocol Deviations.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218664">C218664</a></td><td>ICH M11 Protocol Section 11.11 Early Site Closure</td><td>The title of section 11.11 of the ICH M11 protocol guideline: Early Site Closure.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218665">C218665</a></td><td>ICH M11 Protocol Section 11.12 Data Dissemination</td><td>The title of section 11.12 of the ICH M11 protocol guideline: Data Dissemination.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218666">C218666</a></td><td>ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS</td><td>The title of section 12 of the ICH M11 protocol guideline: APPENDIX: SUPPORTING DETAILS.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218667">C218667</a></td><td>ICH M11 Protocol Section 12.1 Clinical Laboratory Tests</td><td>The title of section 12.1 of the ICH M11 protocol guideline: Clinical Laboratory Tests.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218668">C218668</a></td><td>ICH M11 Protocol Section 12.2 Country/Region-Specific Differences</td><td>The title of section 12.2 of the ICH M11 protocol guideline: Country/Region-Specific Differences.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218669">C218669</a></td><td>ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s)</td><td>The title of section 12.3 of the ICH M11 protocol guideline: Prior Protocol Amendment(s).</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218670">C218670</a></td><td>ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS</td><td>The title of section 13 of the ICH M11 protocol guideline: APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS.</td></tr><tr><td><a href="CodeSystem-ncit-cs.html#ncit-cs-C218671">C218671</a></td><td>ICH M11 Protocol Section 14 APPENDIX: REFERENCES</td><td>The title of section 14 of the ICH M11 protocol guideline: APPENDIX: REFERENCES.</td></tr></table></li></ul></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
        <valueInteger value="2"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
        <valueCode value="brr"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
        <valueCode value="trial-use">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
            <valueCanonical
                            value="http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"/>
          </extension>
        </valueCode>
      </extension>
      <url
           value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-section-codes-vs"/>
      <version value="1.0.0-ballot2"/>
      <name value="UDPSectionCodesVS"/>
      <title value="UDP Section Codes Value Set"/>
      <status value="active"/>
      <experimental value="false"/>
      <date value="2026-04-09T17:15:23+10:00"/>
      <publisher value="HL7 International / Biomedical Research and Regulation"/>
      <contact>
        <name value="HL7 International / Biomedical Research and Regulation"/>
        <telecom>
          <system value="url"/>
          <value value="http://www.hl7.org/Special/committees/rcrim"/>
        </telecom>
        <telecom>
          <system value="email"/>
          <value value="UDP@HL7Vulcan.org"/>
        </telecom>
      </contact>
      <description
                   value="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 value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
          <code value="001"/>
          <display value="World"/>
        </coding>
      </jurisdiction>
      <copyright
                 value="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 value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <concept>
            <code value="C222769"/>
            <display value="ICH M11 Protocol Section Title Page"/>
          </concept>
          <concept>
            <code value="C218514"/>
            <display value="ICH M11 Protocol Section 1 PROTOCOL SUMMARY"/>
          </concept>
          <concept>
            <code value="C218515"/>
            <display value="ICH M11 Protocol Section 1.1 Protocol Synopsis"/>
          </concept>
          <concept>
            <code value="C218516"/>
            <display
                     value="ICH M11 Protocol Section 1.1.1 Primary and Secondary Objectives and Estimands"/>
          </concept>
          <concept>
            <code value="C218517"/>
            <display value="ICH M11 Protocol Section 1.1.2 Overall Design"/>
          </concept>
          <concept>
            <code value="C218518"/>
            <display value="ICH M11 Protocol Section 1.2 Trial Schema"/>
          </concept>
          <concept>
            <code value="C218519"/>
            <display value="ICH M11 Protocol Section 1.3 Schedule of Activities"/>
          </concept>
          <concept>
            <code value="C218520"/>
            <display value="ICH M11 Protocol Section 2 INTRODUCTION"/>
          </concept>
          <concept>
            <code value="C218521"/>
            <display value="ICH M11 Protocol Section 2.1 Purpose of Trial"/>
          </concept>
          <concept>
            <code value="C218522"/>
            <display
                     value="ICH M11 Protocol Section 2.2 Assessment of Risks and Benefits"/>
          </concept>
          <concept>
            <code value="C218523"/>
            <display
                     value="ICH M11 Protocol Section 2.2.1 Risk Summary and Mitigation Strategy"/>
          </concept>
          <concept>
            <code value="C218524"/>
            <display value="ICH M11 Protocol Section 2.2.2 Benefit Summary"/>
          </concept>
          <concept>
            <code value="C218525"/>
            <display
                     value="ICH M11 Protocol Section 2.2.3 Overall Risk-Benefit Assessment"/>
          </concept>
          <concept>
            <code value="C218526"/>
            <display
                     value="ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS"/>
          </concept>
          <concept>
            <code value="C218527"/>
            <display
                     value="ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s)"/>
          </concept>
          <concept>
            <code value="C218528"/>
            <display value="ICH M11 Protocol Section 3.1.1 Primary Objective"/>
          </concept>
          <concept>
            <code value="C218529"/>
            <display
                     value="ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s)"/>
          </concept>
          <concept>
            <code value="C218530"/>
            <display value="ICH M11 Protocol Section 3.2.1 Secondary Objective"/>
          </concept>
          <concept>
            <code value="C218531"/>
            <display
                     value="ICH M11 Protocol Section 3.3 Exploratory Objective(s)"/>
          </concept>
          <concept>
            <code value="C218532"/>
            <display
                     value="ICH M11 Protocol Section 3.3.1 Exploratory Objective"/>
          </concept>
          <concept>
            <code value="C218533"/>
            <display value="ICH M11 Protocol Section 4 TRIAL DESIGN"/>
          </concept>
          <concept>
            <code value="C218534"/>
            <display
                     value="ICH M11 Protocol Section 4.1 Description of Trial Design"/>
          </concept>
          <concept>
            <code value="C218535"/>
            <display
                     value="ICH M11 Protocol Section 4.1.1 Stakeholder Input into Design"/>
          </concept>
          <concept>
            <code value="C218536"/>
            <display
                     value="ICH M11 Protocol Section 4.2 Rationale for Trial Design"/>
          </concept>
          <concept>
            <code value="C218537"/>
            <display
                     value="ICH M11 Protocol Section 4.2.1 Rationale for Estimand(s)"/>
          </concept>
          <concept>
            <code value="C218538"/>
            <display
                     value="ICH M11 Protocol Section 4.2.2 Rationale for Intervention Model"/>
          </concept>
          <concept>
            <code value="C218539"/>
            <display
                     value="ICH M11 Protocol Section 4.2.3 Rationale for Control Type"/>
          </concept>
          <concept>
            <code value="C218540"/>
            <display
                     value="ICH M11 Protocol Section 4.2.4 Rationale for Trial Duration"/>
          </concept>
          <concept>
            <code value="C218541"/>
            <display
                     value="ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial Design"/>
          </concept>
          <concept>
            <code value="C218542"/>
            <display
                     value="ICH M11 Protocol Section 4.2.6 Rationale for Interim Analysis"/>
          </concept>
          <concept>
            <code value="C218543"/>
            <display
                     value="ICH M11 Protocol Section 4.2.7 Rationale for Other Trial Design Aspects"/>
          </concept>
          <concept>
            <code value="C218544"/>
            <display value="ICH M11 Protocol Section 4.3 Trial Stopping Rules"/>
          </concept>
          <concept>
            <code value="C218545"/>
            <display
                     value="ICH M11 Protocol Section 4.4 Start of Trial and End of Trial"/>
          </concept>
          <concept>
            <code value="C218546"/>
            <display
                     value="ICH M11 Protocol Section 4.5 Access to Trial Intervention After End of Trial"/>
          </concept>
          <concept>
            <code value="C218547"/>
            <display value="ICH M11 Protocol Section 5 TRIAL POPULATION"/>
          </concept>
          <concept>
            <code value="C218548"/>
            <display
                     value="ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale"/>
          </concept>
          <concept>
            <code value="C218549"/>
            <display value="ICH M11 Protocol Section 5.2 Inclusion Criteria"/>
          </concept>
          <concept>
            <code value="C218550"/>
            <display value="ICH M11 Protocol Section 5.3 Exclusion Criteria"/>
          </concept>
          <concept>
            <code value="C218551"/>
            <display value="ICH M11 Protocol Section 5.4 Contraception"/>
          </concept>
          <concept>
            <code value="C218552"/>
            <display
                     value="ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential"/>
          </concept>
          <concept>
            <code value="C218553"/>
            <display
                     value="ICH M11 Protocol Section 5.4.2 Contraception Requirements"/>
          </concept>
          <concept>
            <code value="C218554"/>
            <display value="ICH M11 Protocol Section 5.5 Lifestyle Restrictions"/>
          </concept>
          <concept>
            <code value="C218555"/>
            <display
                     value="ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions"/>
          </concept>
          <concept>
            <code value="C218556"/>
            <display
                     value="ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions"/>
          </concept>
          <concept>
            <code value="C218557"/>
            <display
                     value="ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions"/>
          </concept>
          <concept>
            <code value="C218558"/>
            <display
                     value="ICH M11 Protocol Section 5.5.4 Other Activity Restrictions"/>
          </concept>
          <concept>
            <code value="C218559"/>
            <display
                     value="ICH M11 Protocol Section 5.6 Screen Failure and Rescreening"/>
          </concept>
          <concept>
            <code value="C218560"/>
            <display
                     value="ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY"/>
          </concept>
          <concept>
            <code value="C218561"/>
            <display
                     value="ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention"/>
          </concept>
          <concept>
            <code value="C218562"/>
            <display
                     value="ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen"/>
          </concept>
          <concept>
            <code value="C218563"/>
            <display
                     value="ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration"/>
          </concept>
          <concept>
            <code value="C218564"/>
            <display
                     value="ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification"/>
          </concept>
          <concept>
            <code value="C218565"/>
            <display
                     value="ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose"/>
          </concept>
          <concept>
            <code value="C218566"/>
            <display
                     value="ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention"/>
          </concept>
          <concept>
            <code value="C218567"/>
            <display
                     value="ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention"/>
          </concept>
          <concept>
            <code value="C218568"/>
            <display
                     value="ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention"/>
          </concept>
          <concept>
            <code value="C218569"/>
            <display
                     value="ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention"/>
          </concept>
          <concept>
            <code value="C218570"/>
            <display
                     value="ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding"/>
          </concept>
          <concept>
            <code value="C218571"/>
            <display
                     value="ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention"/>
          </concept>
          <concept>
            <code value="C218572"/>
            <display value="ICH M11 Protocol Section 6.7.2 Randomisation"/>
          </concept>
          <concept>
            <code value="C218573"/>
            <display
                     value="ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding"/>
          </concept>
          <concept>
            <code value="C218574"/>
            <display
                     value="ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site"/>
          </concept>
          <concept>
            <code value="C218575"/>
            <display
                     value="ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence"/>
          </concept>
          <concept>
            <code value="C218576"/>
            <display
                     value="ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention"/>
          </concept>
          <concept>
            <code value="C218577"/>
            <display
                     value="ICH M11 Protocol Section 6.9.1 Background Trial Intervention"/>
          </concept>
          <concept>
            <code value="C218578"/>
            <display value="ICH M11 Protocol Section 6.9.2 Rescue Therapy"/>
          </concept>
          <concept>
            <code value="C218579"/>
            <display
                     value="ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention"/>
          </concept>
          <concept>
            <code value="C218580"/>
            <display value="ICH M11 Protocol Section 6.10 Concomitant Therapy"/>
          </concept>
          <concept>
            <code value="C218581"/>
            <display
                     value="ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy"/>
          </concept>
          <concept>
            <code value="C218582"/>
            <display
                     value="ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy"/>
          </concept>
          <concept>
            <code value="C218583"/>
            <display
                     value="ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL"/>
          </concept>
          <concept>
            <code value="C218584"/>
            <display
                     value="ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants"/>
          </concept>
          <concept>
            <code value="C218585"/>
            <display
                     value="ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention"/>
          </concept>
          <concept>
            <code value="C218586"/>
            <display
                     value="ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention"/>
          </concept>
          <concept>
            <code value="C218587"/>
            <display value="ICH M11 Protocol Section 7.1.3 Rechallenge"/>
          </concept>
          <concept>
            <code value="C218588"/>
            <display
                     value="ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial"/>
          </concept>
          <concept>
            <code value="C218589"/>
            <display
                     value="ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up"/>
          </concept>
          <concept>
            <code value="C218590"/>
            <display
                     value="ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES"/>
          </concept>
          <concept>
            <code value="C218591"/>
            <display
                     value="ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations"/>
          </concept>
          <concept>
            <code value="C218592"/>
            <display
                     value="ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures"/>
          </concept>
          <concept>
            <code value="C218593"/>
            <display
                     value="ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures"/>
          </concept>
          <concept>
            <code value="C218594"/>
            <display
                     value="ICH M11 Protocol Section 8.4 Safety Assessments and Procedures"/>
          </concept>
          <concept>
            <code value="C218595"/>
            <display value="ICH M11 Protocol Section 8.4.1 Physical Examination"/>
          </concept>
          <concept>
            <code value="C218596"/>
            <display value="ICH M11 Protocol Section 8.4.2 Vital Signs"/>
          </concept>
          <concept>
            <code value="C218597"/>
            <display value="ICH M11 Protocol Section 8.4.3 Electrocardiograms"/>
          </concept>
          <concept>
            <code value="C218598"/>
            <display
                     value="ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments"/>
          </concept>
          <concept>
            <code value="C218599"/>
            <display value="ICH M11 Protocol Section 8.4.5 Pregnancy Testing"/>
          </concept>
          <concept>
            <code value="C218600"/>
            <display
                     value="ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring"/>
          </concept>
          <concept>
            <code value="C218601"/>
            <display value="ICH M11 Protocol Section 8.5 Pharmacokinetics"/>
          </concept>
          <concept>
            <code value="C218602"/>
            <display value="ICH M11 Protocol Section 8.6 Biomarkers"/>
          </concept>
          <concept>
            <code value="C218603"/>
            <display
                     value="ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics"/>
          </concept>
          <concept>
            <code value="C218604"/>
            <display
                     value="ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers"/>
          </concept>
          <concept>
            <code value="C218605"/>
            <display value="ICH M11 Protocol Section 8.6.3 Other Biomarkers"/>
          </concept>
          <concept>
            <code value="C218606"/>
            <display
                     value="ICH M11 Protocol Section 8.7 Immunogenicity Assessments"/>
          </concept>
          <concept>
            <code value="C218607"/>
            <display
                     value="ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics"/>
          </concept>
          <concept>
            <code value="C218608"/>
            <display
                     value="ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS"/>
          </concept>
          <concept>
            <code value="C218609"/>
            <display value="ICH M11 Protocol Section 9.1 Definitions"/>
          </concept>
          <concept>
            <code value="C218610"/>
            <display
                     value="ICH M11 Protocol Section 9.1.1 Definitions of Adverse Events"/>
          </concept>
          <concept>
            <code value="C218611"/>
            <display
                     value="ICH M11 Protocol Section 9.1.2 Definitions of Serious Adverse Events"/>
          </concept>
          <concept>
            <code value="C218612"/>
            <display
                     value="ICH M11 Protocol Section 9.1.3 Definitions of Product Complaints"/>
          </concept>
          <concept>
            <code value="C218613"/>
            <display
                     value="ICH M11 Protocol Section 9.1.3.1 Definitions of Medical Device Product Complaints"/>
          </concept>
          <concept>
            <code value="C218614"/>
            <display
                     value="ICH M11 Protocol Section 9.2 Timing and Procedures for Collection and Reporting"/>
          </concept>
          <concept>
            <code value="C218615"/>
            <display value="ICH M11 Protocol Section 9.2.1 Timing"/>
          </concept>
          <concept>
            <code value="C218616"/>
            <display
                     value="ICH M11 Protocol Section 9.2.2 Collection Procedures"/>
          </concept>
          <concept>
            <code value="C218617"/>
            <display value="ICH M11 Protocol Section 9.2.3 Reporting"/>
          </concept>
          <concept>
            <code value="C218618"/>
            <display
                     value="ICH M11 Protocol Section 9.2.3.1 Regulatory Reporting Requirements"/>
          </concept>
          <concept>
            <code value="C218619"/>
            <display
                     value="ICH M11 Protocol Section 9.2.4 Adverse Events of Special Interest"/>
          </concept>
          <concept>
            <code value="C218620"/>
            <display
                     value="ICH M11 Protocol Section 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs"/>
          </concept>
          <concept>
            <code value="C218621"/>
            <display
                     value="ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information"/>
          </concept>
          <concept>
            <code value="C218622"/>
            <display
                     value="ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the Trial"/>
          </concept>
          <concept>
            <code value="C218623"/>
            <display
                     value="ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the Trial"/>
          </concept>
          <concept>
            <code value="C218624"/>
            <display
                     value="ICH M11 Protocol Section 9.4 Special Safety Situations"/>
          </concept>
          <concept>
            <code value="C218625"/>
            <display
                     value="ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS"/>
          </concept>
          <concept>
            <code value="C218626"/>
            <display
                     value="ICH M11 Protocol Section 10.1 General Considerations"/>
          </concept>
          <concept>
            <code value="C218627"/>
            <display value="ICH M11 Protocol Section 10.2 Analysis Sets"/>
          </concept>
          <concept>
            <code value="C218628"/>
            <display
                     value="ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables"/>
          </concept>
          <concept>
            <code value="C218629"/>
            <display
                     value="ICH M11 Protocol Section 10.4 Analyses Associated with the Primary Objective(s)"/>
          </concept>
          <concept>
            <code value="C218630"/>
            <display value="ICH M11 Protocol Section 10.4.1 Primary Objective"/>
          </concept>
          <concept>
            <code value="C218631"/>
            <display
                     value="ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method"/>
          </concept>
          <concept>
            <code value="C218632"/>
            <display
                     value="ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)"/>
          </concept>
          <concept>
            <code value="C218633"/>
            <display
                     value="ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)"/>
          </concept>
          <concept>
            <code value="C218634"/>
            <display
                     value="ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis"/>
          </concept>
          <concept>
            <code value="C218635"/>
            <display
                     value="ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis"/>
          </concept>
          <concept>
            <code value="C218636"/>
            <display
                     value="ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)"/>
          </concept>
          <concept>
            <code value="C218637"/>
            <display value="ICH M11 Protocol Section 10.5.1 Secondary Objective"/>
          </concept>
          <concept>
            <code value="C218638"/>
            <display
                     value="ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method"/>
          </concept>
          <concept>
            <code value="C218639"/>
            <display
                     value="ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)"/>
          </concept>
          <concept>
            <code value="C218640"/>
            <display
                     value="ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)"/>
          </concept>
          <concept>
            <code value="C218641"/>
            <display
                     value="ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis"/>
          </concept>
          <concept>
            <code value="C218642"/>
            <display
                     value="ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis"/>
          </concept>
          <concept>
            <code value="C218643"/>
            <display
                     value="ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)"/>
          </concept>
          <concept>
            <code value="C218644"/>
            <display value="ICH M11 Protocol Section 10.7 Safety Analyses"/>
          </concept>
          <concept>
            <code value="C218645"/>
            <display value="ICH M11 Protocol Section 10.8 Other Analyses"/>
          </concept>
          <concept>
            <code value="C218646"/>
            <display value="ICH M11 Protocol Section 10.9 Interim Analyses"/>
          </concept>
          <concept>
            <code value="C218647"/>
            <display
                     value="ICH M11 Protocol Section 10.10 Multiplicity Adjustments"/>
          </concept>
          <concept>
            <code value="C218648"/>
            <display
                     value="ICH M11 Protocol Section 10.11 Sample Size Determination"/>
          </concept>
          <concept>
            <code value="C218649"/>
            <display
                     value="ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS"/>
          </concept>
          <concept>
            <code value="C218650"/>
            <display
                     value="ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations"/>
          </concept>
          <concept>
            <code value="C218651"/>
            <display value="ICH M11 Protocol Section 11.2 Trial Oversight"/>
          </concept>
          <concept>
            <code value="C218652"/>
            <display
                     value="ICH M11 Protocol Section 11.2.1 Investigator Responsibilities"/>
          </concept>
          <concept>
            <code value="C218653"/>
            <display
                     value="ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities"/>
          </concept>
          <concept>
            <code value="C218654"/>
            <display
                     value="ICH M11 Protocol Section 11.3 Informed Consent Process"/>
          </concept>
          <concept>
            <code value="C218655"/>
            <display
                     value="ICH M11 Protocol Section 11.3.1 Informed Consent for Rescreening"/>
          </concept>
          <concept>
            <code value="C218656"/>
            <display
                     value="ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research"/>
          </concept>
          <concept>
            <code value="C218657"/>
            <display value="ICH M11 Protocol Section 11.4 Committees"/>
          </concept>
          <concept>
            <code value="C218658"/>
            <display
                     value="ICH M11 Protocol Section 11.5 Insurance and Indemnity"/>
          </concept>
          <concept>
            <code value="C218659"/>
            <display
                     value="ICH M11 Protocol Section 11.6 Risk-Based Quality Management"/>
          </concept>
          <concept>
            <code value="C218660"/>
            <display value="ICH M11 Protocol Section 11.7 Data Governance"/>
          </concept>
          <concept>
            <code value="C218661"/>
            <display value="ICH M11 Protocol Section 11.8 Data Protection"/>
          </concept>
          <concept>
            <code value="C218662"/>
            <display value="ICH M11 Protocol Section 11.9 Source Records"/>
          </concept>
          <concept>
            <code value="C218663"/>
            <display value="ICH M11 Protocol Section 11.10 Protocol Deviations"/>
          </concept>
          <concept>
            <code value="C218664"/>
            <display value="ICH M11 Protocol Section 11.11 Early Site Closure"/>
          </concept>
          <concept>
            <code value="C218665"/>
            <display value="ICH M11 Protocol Section 11.12 Data Dissemination"/>
          </concept>
          <concept>
            <code value="C218666"/>
            <display
                     value="ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS"/>
          </concept>
          <concept>
            <code value="C218667"/>
            <display
                     value="ICH M11 Protocol Section 12.1 Clinical Laboratory Tests"/>
          </concept>
          <concept>
            <code value="C218668"/>
            <display
                     value="ICH M11 Protocol Section 12.2 Country/Region-Specific Differences"/>
          </concept>
          <concept>
            <code value="C218669"/>
            <display
                     value="ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s)"/>
          </concept>
          <concept>
            <code value="C218670"/>
            <display
                     value="ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS"/>
          </concept>
          <concept>
            <code value="C218671"/>
            <display value="ICH M11 Protocol Section 14 APPENDIX: REFERENCES"/>
          </concept>
        </include>
      </compose>
    </ValueSet>