Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2
Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2
Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions
| Page standards status: Trial-use | Maturity Level: 2 |
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<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 📦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>
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<code value="C218525"/>
<display
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<concept>
<code value="C218526"/>
<display
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<concept>
<code value="C218527"/>
<display
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<concept>
<code value="C218528"/>
<display value="ICH M11 Protocol Section 3.1.1 Primary Objective"/>
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<concept>
<code value="C218529"/>
<display
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<concept>
<code value="C218530"/>
<display value="ICH M11 Protocol Section 3.2.1 Secondary Objective"/>
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<concept>
<code value="C218531"/>
<display
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</concept>
<concept>
<code value="C218532"/>
<display
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<concept>
<code value="C218533"/>
<display value="ICH M11 Protocol Section 4 TRIAL DESIGN"/>
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<concept>
<code value="C218534"/>
<display
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</concept>
<concept>
<code value="C218535"/>
<display
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<concept>
<code value="C218536"/>
<display
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<concept>
<code value="C218537"/>
<display
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<concept>
<code value="C218538"/>
<display
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<concept>
<code value="C218539"/>
<display
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</concept>
<concept>
<code value="C218540"/>
<display
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</concept>
<concept>
<code value="C218541"/>
<display
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</concept>
<concept>
<code value="C218542"/>
<display
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<concept>
<code value="C218543"/>
<display
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<concept>
<code value="C218544"/>
<display value="ICH M11 Protocol Section 4.3 Trial Stopping Rules"/>
</concept>
<concept>
<code value="C218545"/>
<display
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<concept>
<code value="C218546"/>
<display
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<concept>
<code value="C218547"/>
<display value="ICH M11 Protocol Section 5 TRIAL POPULATION"/>
</concept>
<concept>
<code value="C218548"/>
<display
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<concept>
<code value="C218549"/>
<display value="ICH M11 Protocol Section 5.2 Inclusion Criteria"/>
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<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
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<concept>
<code value="C218553"/>
<display
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<concept>
<code value="C218554"/>
<display value="ICH M11 Protocol Section 5.5 Lifestyle Restrictions"/>
</concept>
<concept>
<code value="C218555"/>
<display
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<concept>
<code value="C218556"/>
<display
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<concept>
<code value="C218557"/>
<display
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</concept>
<concept>
<code value="C218558"/>
<display
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</concept>
<concept>
<code value="C218559"/>
<display
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<concept>
<code value="C218560"/>
<display
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<concept>
<code value="C218561"/>
<display
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<concept>
<code value="C218562"/>
<display
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<concept>
<code value="C218563"/>
<display
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<concept>
<code value="C218564"/>
<display
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</concept>
<concept>
<code value="C218565"/>
<display
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<concept>
<code value="C218566"/>
<display
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<concept>
<code value="C218567"/>
<display
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<concept>
<code value="C218568"/>
<display
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<concept>
<code value="C218569"/>
<display
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<concept>
<code value="C218570"/>
<display
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<concept>
<code value="C218571"/>
<display
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<concept>
<code value="C218572"/>
<display value="ICH M11 Protocol Section 6.7.2 Randomisation"/>
</concept>
<concept>
<code value="C218573"/>
<display
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<concept>
<code value="C218574"/>
<display
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</concept>
<concept>
<code value="C218575"/>
<display
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</concept>
<concept>
<code value="C218576"/>
<display
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</concept>
<concept>
<code value="C218577"/>
<display
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</concept>
<concept>
<code value="C218578"/>
<display value="ICH M11 Protocol Section 6.9.2 Rescue Therapy"/>
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<concept>
<code value="C218579"/>
<display
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<concept>
<code value="C218580"/>
<display value="ICH M11 Protocol Section 6.10 Concomitant Therapy"/>
</concept>
<concept>
<code value="C218581"/>
<display
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</concept>
<concept>
<code value="C218582"/>
<display
value="ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy"/>
</concept>
<concept>
<code value="C218583"/>
<display
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</concept>
<concept>
<code value="C218584"/>
<display
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<concept>
<code value="C218585"/>
<display
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</concept>
<concept>
<code value="C218586"/>
<display
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</concept>
<concept>
<code value="C218587"/>
<display value="ICH M11 Protocol Section 7.1.3 Rechallenge"/>
</concept>
<concept>
<code value="C218588"/>
<display
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</concept>
<concept>
<code value="C218589"/>
<display
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</concept>
<concept>
<code value="C218590"/>
<display
value="ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES"/>
</concept>
<concept>
<code value="C218591"/>
<display
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</concept>
<concept>
<code value="C218592"/>
<display
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</concept>
<concept>
<code value="C218593"/>
<display
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</concept>
<concept>
<code value="C218594"/>
<display
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<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"/>
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<concept>
<code value="C218597"/>
<display value="ICH M11 Protocol Section 8.4.3 Electrocardiograms"/>
</concept>
<concept>
<code value="C218598"/>
<display
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</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
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</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
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</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
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</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
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</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>
IG © 2026+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.clinical-study-protocol#1.0.0-ballot2 based on FHIR 6.0.0-ballot3.
Generated
2026-04-02
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