Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot
Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot
This page is part of the Pharmaceutical Clinical Trial Protocols (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, 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 m11-section-codes-vs</b></p><a name="m11-section-codes-vs"> </a><a name="hcm11-section-codes-vs"> </a><ul><li>Include these codes as defined in <a href="http://terminology.hl7.org/6.5.0/CodeSystem-v3-nciThesaurus.html"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C218514</td><td>1 PROTOCOL SUMMARY</td></tr><tr><td>C218515</td><td>1.1 Protocol Synopsis</td></tr><tr><td>C218516</td><td>1.1.1 Primary and Secondary Objectives and Estimands</td></tr><tr><td>C218517</td><td>1.1.2 Overall Design</td></tr><tr><td>C218518</td><td>1.2 Trial Schema</td></tr><tr><td>C218519</td><td>1.3 Schedule of Activities</td></tr><tr><td>C218520</td><td>2 INTRODUCTION</td></tr><tr><td>C218521</td><td>2.1 Purpose of Trial</td></tr><tr><td>C218522</td><td>2.2 Assessment of Risks and Benefits</td></tr><tr><td>C218523</td><td>2.2.1 Risk Summary and Mitigation Strategy</td></tr><tr><td>C218524</td><td>2.2.2 Benefit Summary</td></tr><tr><td>C218525</td><td>2.2.3 Overall Risk-Benefit Assessment</td></tr><tr><td>C218526</td><td>3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS</td></tr><tr><td>C218527</td><td>3.1 Primary Objective(s) and Associated Estimand(s)</td></tr><tr><td>C218528</td><td>3.1.1 Primary Objective</td></tr><tr><td>C218529</td><td>3.2 Secondary Objective(s) and Associated Estimand(s)</td></tr><tr><td>C218530</td><td>3.2.1 Secondary Objective</td></tr><tr><td>C218531</td><td>3.3 Exploratory Objective(s)</td></tr><tr><td>C218532</td><td>3.3.1 Exploratory Objective</td></tr><tr><td>C218533</td><td>4 TRIAL DESIGN</td></tr><tr><td>C218534</td><td>4.1 Description of Trial Design</td></tr><tr><td>C218535</td><td>4.1.1 Stakeholder Input into Design</td></tr><tr><td>C218536</td><td>4.2 Rationale for Trial Design</td></tr><tr><td>C218537</td><td>4.2.1 Rationale for Estimand(s)</td></tr><tr><td>C218538</td><td>4.2.2 Rationale for Intervention Model</td></tr><tr><td>C218539</td><td>4.2.3 Rationale for Control Type</td></tr><tr><td>C218540</td><td>4.2.4 Rationale for Trial Duration</td></tr><tr><td>C218541</td><td>4.2.5 Rationale for Adaptive or Novel Trial Design</td></tr><tr><td>C218542</td><td>4.2.6 Rationale for Interim Analysis</td></tr><tr><td>C218543</td><td>4.2.7 Rationale for Other Trial Design Aspects</td></tr><tr><td>C218544</td><td>4.3 Trial Stopping Rules</td></tr><tr><td>C218545</td><td>4.4 Start of Trial and End of Trial</td></tr><tr><td>C218546</td><td>4.5 Access to Trial Intervention After End of Trial</td></tr><tr><td>C218547</td><td>5 TRIAL POPULATION</td></tr><tr><td>C218548</td><td>5.1 Description of Trial Population and Rationale</td></tr><tr><td>C218549</td><td>5.2 Inclusion Criteria</td></tr><tr><td>C218550</td><td>5.3 Exclusion Criteria</td></tr><tr><td>C218551</td><td>5.4 Contraception</td></tr><tr><td>C218552</td><td>5.4.1 Definitions Related to Childbearing Potential</td></tr><tr><td>C218553</td><td>5.4.2 Contraception Requirements</td></tr><tr><td>C218554</td><td>5.5 Lifestyle Restrictions</td></tr><tr><td>C218555</td><td>5.5.1 Meals and Dietary Restrictions</td></tr><tr><td>C218556</td><td>5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions</td></tr><tr><td>C218557</td><td>5.5.3 Physical Activity Restrictions</td></tr><tr><td>C218558</td><td>5.5.4 Other Activity Restrictions</td></tr><tr><td>C218559</td><td>5.6 Screen Failure and Rescreening</td></tr><tr><td>C218560</td><td>6 TRIAL INTERVENTION AND CONCOMITANT THERAPY</td></tr><tr><td>C218561</td><td>6.1 Description of Investigational Trial Intervention</td></tr><tr><td>C218562</td><td>6.2 Rationale for Investigational Trial Intervention Dose and Regimen</td></tr><tr><td>C218563</td><td>6.3 Investigational Trial Intervention Administration</td></tr><tr><td>C218564</td><td>6.4 Investigational Trial Intervention Dose Modification</td></tr><tr><td>C218565</td><td>6.5 Management of Investigational Trial Intervention Overdose</td></tr><tr><td>C218566</td><td>6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention</td></tr><tr><td>C218567</td><td>6.6.1 Preparation of Investigational Trial Intervention</td></tr><tr><td>C218568</td><td>6.6.2 Storage and Handling of Investigational Trial Intervention</td></tr><tr><td>C218569</td><td>6.6.3 Accountability of Investigational Trial Intervention</td></tr><tr><td>C218570</td><td>6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding</td></tr><tr><td>C218571</td><td>6.7.1 Participant Assignment to Investigational Trial Intervention</td></tr><tr><td>C218572</td><td>6.7.2 Randomisation</td></tr><tr><td>C218573</td><td>6.7.3 Measures to Maintain Blinding</td></tr><tr><td>C218574</td><td>6.7.4 Emergency Unblinding at the Site</td></tr><tr><td>C218575</td><td>6.8 Investigational Trial Intervention Adherence</td></tr><tr><td>C218576</td><td>6.9 Description of Noninvestigational Trial Intervention</td></tr><tr><td>C218577</td><td>6.9.1 Background Trial Intervention</td></tr><tr><td>C218578</td><td>6.9.2 Rescue Therapy</td></tr><tr><td>C218579</td><td>6.9.3 Other Noninvestigational Trial Intervention</td></tr><tr><td>C218580</td><td>6.10 Concomitant Therapy</td></tr><tr><td>C218581</td><td>6.10.1 Prohibited Concomitant Therapy</td></tr><tr><td>C218582</td><td>6.10.2 Permitted Concomitant Therapy</td></tr><tr><td>C218583</td><td>7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL</td></tr><tr><td>C218584</td><td>7.1 Discontinuation of Trial Intervention for Individual Participants</td></tr><tr><td>C218585</td><td>7.1.1 Permanent Discontinuation of Trial Intervention</td></tr><tr><td>C218586</td><td>7.1.2 Temporary Discontinuation of Trial Intervention</td></tr><tr><td>C218587</td><td>7.1.3 Rechallenge</td></tr><tr><td>C218588</td><td>7.2 Participant Discontinuation or Withdrawal from the Trial</td></tr><tr><td>C218589</td><td>7.3 Management of Loss to Follow-Up</td></tr><tr><td>C218590</td><td>8 TRIAL ASSESSMENTS AND PROCEDURES</td></tr><tr><td>C218591</td><td>8.1 Trial Assessments and Procedures Considerations</td></tr><tr><td>C218592</td><td>8.2 Screening/Baseline Assessments and Procedures</td></tr><tr><td>C218593</td><td>8.3 Efficacy Assessments and Procedures</td></tr><tr><td>C218594</td><td>8.4 Safety Assessments and Procedures</td></tr><tr><td>C218595</td><td>8.4.1 Physical Examination</td></tr><tr><td>C218596</td><td>8.4.2 Vital Signs</td></tr><tr><td>C218597</td><td>8.4.3 Electrocardiograms</td></tr><tr><td>C218598</td><td>8.4.4 Clinical Laboratory Assessments</td></tr><tr><td>C218599</td><td>8.4.5 Pregnancy Testing</td></tr><tr><td>C218600</td><td>8.4.6 Suicidal Ideation and Behaviour Risk Monitoring</td></tr><tr><td>C218601</td><td>8.5 Pharmacokinetics</td></tr><tr><td>C218602</td><td>8.6 Biomarkers</td></tr><tr><td>C218603</td><td>8.6.1 Genetics and Pharmacogenomics</td></tr><tr><td>C218604</td><td>8.6.2 Pharmacodynamic Biomarkers</td></tr><tr><td>C218605</td><td>8.6.3 Other Biomarkers</td></tr><tr><td>C218606</td><td>8.7 Immunogenicity Assessments</td></tr><tr><td>C218607</td><td>8.8 Medical Resource Utilisation and Health Economics</td></tr><tr><td>C218608</td><td>9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS</td></tr><tr><td>C218609</td><td>9.1 Definitions</td></tr><tr><td>C218610</td><td>9.1.1 Definitions of Adverse Events</td></tr><tr><td>C218611</td><td>9.1.2 Definitions of Serious Adverse Events</td></tr><tr><td>C218612</td><td>9.1.3 Definitions of Product Complaints</td></tr><tr><td>C218613</td><td>9.1.3.1 Definition of Medical Device Product Complaints</td></tr><tr><td>C218614</td><td>9.2 Timing and Procedures for Collection and Reporting</td></tr><tr><td>C218615</td><td>9.2.1 Timing</td></tr><tr><td>C218616</td><td>9.2.2 Collection Procedures</td></tr><tr><td>C218617</td><td>9.2.3 Reporting</td></tr><tr><td>C218618</td><td>9.2.3.1 Regulatory Reporting Requirements</td></tr><tr><td>C218619</td><td>9.2.4 Adverse Events of Special Interest</td></tr><tr><td>C218620</td><td>9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs</td></tr><tr><td>C218621</td><td>9.3 Pregnancy and Postpartum Information</td></tr><tr><td>C218622</td><td>9.3.1 Participants Who Become Pregnant During the Trial</td></tr><tr><td>C218623</td><td>9.3.2 Participants Whose Partners Become Pregnant During the Trial</td></tr><tr><td>C218624</td><td>9.4 Special Safety Situations</td></tr><tr><td>C218625</td><td>10 STATISTICAL CONSIDERATIONS</td></tr><tr><td>C218626</td><td>10.1 General Considerations</td></tr><tr><td>C218627</td><td>10.2 Analysis Sets</td></tr><tr><td>C218628</td><td>10.3 Analyses of Demographics and Other Baseline Variables</td></tr><tr><td>C218629</td><td>10.4 Analyses Associated with the Primary Objective(s)</td></tr><tr><td>C218630</td><td>10.4.1 Primary Objective</td></tr><tr><td>C218631</td><td>10.4.1.1 Statistical Analysis Method</td></tr><tr><td>C218632</td><td>10.4.1.2 Handling of Data in Relation to Primary Estimand(s)</td></tr><tr><td>C218633</td><td>10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)</td></tr><tr><td>C218634</td><td>10.4.1.4 Sensitivity Analysis</td></tr><tr><td>C218635</td><td>10.4.1.5 Supplementary Analysis</td></tr><tr><td>C218636</td><td>10.5 Analyses Associated with the Secondary Objective(s)</td></tr><tr><td>C218637</td><td>10.5.1 Secondary Objective</td></tr><tr><td>C218638</td><td>10.5.1.1 Statistical Analysis Method</td></tr><tr><td>C218639</td><td>10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)</td></tr><tr><td>C218640</td><td>10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)</td></tr><tr><td>C218641</td><td>10.5.1.4 Sensitivity Analysis</td></tr><tr><td>C218642</td><td>10.5.1.5 Supplementary Analysis</td></tr><tr><td>C218643</td><td>10.6 Analyses Associated with the Exploratory Objective(s)</td></tr><tr><td>C218644</td><td>10.7 Safety Analyses</td></tr><tr><td>C218645</td><td>10.8 Other Analyses</td></tr><tr><td>C218646</td><td>10.9 Interim Analyses</td></tr><tr><td>C218647</td><td>10.10 Multiplicity Adjustments</td></tr><tr><td>C218648</td><td>10.11 Sample Size Determination</td></tr><tr><td>C218649</td><td>11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS</td></tr><tr><td>C218650</td><td>11.1 Regulatory and Ethical Considerations</td></tr><tr><td>C218651</td><td>11.2 Trial Oversight</td></tr><tr><td>C218652</td><td>11.2.1 Investigator Responsibilities</td></tr><tr><td>C218653</td><td>11.2.2 Sponsor Responsibilities</td></tr><tr><td>C218654</td><td>11.3 Informed Consent Process</td></tr><tr><td>C218655</td><td>11.3.1 Informed Consent for Rescreening</td></tr><tr><td>C218656</td><td>11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research</td></tr><tr><td>C218657</td><td>11.4 Committees</td></tr><tr><td>C218658</td><td>11.5 Insurance and Indemnity</td></tr><tr><td>C218659</td><td>11.6 Risk-Based Quality Management</td></tr><tr><td>C218660</td><td>11.7 Data Governance</td></tr><tr><td>C218661</td><td>11.8 Data Protection</td></tr><tr><td>C218662</td><td>11.9 Source Data</td></tr><tr><td>C218663</td><td>11.10 Protocol Deviations</td></tr><tr><td>C218664</td><td>11.11 Early Site Closure</td></tr><tr><td>C218665</td><td>11.12 Data Dissemination</td></tr><tr><td>C218666</td><td>12 APPENDIX: SUPPORTING DETAILS</td></tr><tr><td>C218667</td><td>12.1 Clinical Laboratory Tests</td></tr><tr><td>C218668</td><td>12.2 Country/Region-Specific Differences</td></tr><tr><td>C218669</td><td>12.3 Prior Protocol Amendment(s)</td></tr><tr><td>C218670</td><td>13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS</td></tr><tr><td>C218671</td><td>14 APPENDIX: REFERENCES</td></tr></table></li></ul></div>
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<display
value="7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL"/>
</concept>
<concept>
<code value="C218584"/>
<display
value="7.1 Discontinuation of Trial Intervention for Individual Participants"/>
</concept>
<concept>
<code value="C218585"/>
<display
value="7.1.1 Permanent Discontinuation of Trial Intervention"/>
</concept>
<concept>
<code value="C218586"/>
<display
value="7.1.2 Temporary Discontinuation of Trial Intervention"/>
</concept>
<concept>
<code value="C218587"/>
<display value="7.1.3 Rechallenge"/>
</concept>
<concept>
<code value="C218588"/>
<display
value="7.2 Participant Discontinuation or Withdrawal from the Trial"/>
</concept>
<concept>
<code value="C218589"/>
<display value="7.3 Management of Loss to Follow-Up"/>
</concept>
<concept>
<code value="C218590"/>
<display value="8 TRIAL ASSESSMENTS AND PROCEDURES"/>
</concept>
<concept>
<code value="C218591"/>
<display value="8.1 Trial Assessments and Procedures Considerations"/>
</concept>
<concept>
<code value="C218592"/>
<display value="8.2 Screening/Baseline Assessments and Procedures"/>
</concept>
<concept>
<code value="C218593"/>
<display value="8.3 Efficacy Assessments and Procedures"/>
</concept>
<concept>
<code value="C218594"/>
<display value="8.4 Safety Assessments and Procedures"/>
</concept>
<concept>
<code value="C218595"/>
<display value="8.4.1 Physical Examination"/>
</concept>
<concept>
<code value="C218596"/>
<display value="8.4.2 Vital Signs"/>
</concept>
<concept>
<code value="C218597"/>
<display value="8.4.3 Electrocardiograms"/>
</concept>
<concept>
<code value="C218598"/>
<display value="8.4.4 Clinical Laboratory Assessments"/>
</concept>
<concept>
<code value="C218599"/>
<display value="8.4.5 Pregnancy Testing"/>
</concept>
<concept>
<code value="C218600"/>
<display
value="8.4.6 Suicidal Ideation and Behaviour Risk Monitoring"/>
</concept>
<concept>
<code value="C218601"/>
<display value="8.5 Pharmacokinetics"/>
</concept>
<concept>
<code value="C218602"/>
<display value="8.6 Biomarkers"/>
</concept>
<concept>
<code value="C218603"/>
<display value="8.6.1 Genetics and Pharmacogenomics"/>
</concept>
<concept>
<code value="C218604"/>
<display value="8.6.2 Pharmacodynamic Biomarkers"/>
</concept>
<concept>
<code value="C218605"/>
<display value="8.6.3 Other Biomarkers"/>
</concept>
<concept>
<code value="C218606"/>
<display value="8.7 Immunogenicity Assessments"/>
</concept>
<concept>
<code value="C218607"/>
<display
value="8.8 Medical Resource Utilisation and Health Economics"/>
</concept>
<concept>
<code value="C218608"/>
<display
value="9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS"/>
</concept>
<concept>
<code value="C218609"/>
<display value="9.1 Definitions"/>
</concept>
<concept>
<code value="C218610"/>
<display value="9.1.1 Definitions of Adverse Events"/>
</concept>
<concept>
<code value="C218611"/>
<display value="9.1.2 Definitions of Serious Adverse Events"/>
</concept>
<concept>
<code value="C218612"/>
<display value="9.1.3 Definitions of Product Complaints"/>
</concept>
<concept>
<code value="C218613"/>
<display
value="9.1.3.1 Definition of Medical Device Product Complaints"/>
</concept>
<concept>
<code value="C218614"/>
<display
value="9.2 Timing and Procedures for Collection and Reporting"/>
</concept>
<concept>
<code value="C218615"/>
<display value="9.2.1 Timing"/>
</concept>
<concept>
<code value="C218616"/>
<display value="9.2.2 Collection Procedures"/>
</concept>
<concept>
<code value="C218617"/>
<display value="9.2.3 Reporting"/>
</concept>
<concept>
<code value="C218618"/>
<display value="9.2.3.1 Regulatory Reporting Requirements"/>
</concept>
<concept>
<code value="C218619"/>
<display value="9.2.4 Adverse Events of Special Interest"/>
</concept>
<concept>
<code value="C218620"/>
<display
value="9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs"/>
</concept>
<concept>
<code value="C218621"/>
<display value="9.3 Pregnancy and Postpartum Information"/>
</concept>
<concept>
<code value="C218622"/>
<display
value="9.3.1 Participants Who Become Pregnant During the Trial"/>
</concept>
<concept>
<code value="C218623"/>
<display
value="9.3.2 Participants Whose Partners Become Pregnant During the Trial"/>
</concept>
<concept>
<code value="C218624"/>
<display value="9.4 Special Safety Situations"/>
</concept>
<concept>
<code value="C218625"/>
<display value="10 STATISTICAL CONSIDERATIONS"/>
</concept>
<concept>
<code value="C218626"/>
<display value="10.1 General Considerations"/>
</concept>
<concept>
<code value="C218627"/>
<display value="10.2 Analysis Sets"/>
</concept>
<concept>
<code value="C218628"/>
<display
value="10.3 Analyses of Demographics and Other Baseline Variables"/>
</concept>
<concept>
<code value="C218629"/>
<display
value="10.4 Analyses Associated with the Primary Objective(s)"/>
</concept>
<concept>
<code value="C218630"/>
<display value="10.4.1 Primary Objective"/>
</concept>
<concept>
<code value="C218631"/>
<display value="10.4.1.1 Statistical Analysis Method"/>
</concept>
<concept>
<code value="C218632"/>
<display
value="10.4.1.2 Handling of Data in Relation to Primary Estimand(s)"/>
</concept>
<concept>
<code value="C218633"/>
<display
value="10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)"/>
</concept>
<concept>
<code value="C218634"/>
<display value="10.4.1.4 Sensitivity Analysis"/>
</concept>
<concept>
<code value="C218635"/>
<display value="10.4.1.5 Supplementary Analysis"/>
</concept>
<concept>
<code value="C218636"/>
<display
value="10.5 Analyses Associated with the Secondary Objective(s)"/>
</concept>
<concept>
<code value="C218637"/>
<display value="10.5.1 Secondary Objective"/>
</concept>
<concept>
<code value="C218638"/>
<display value="10.5.1.1 Statistical Analysis Method"/>
</concept>
<concept>
<code value="C218639"/>
<display
value="10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)"/>
</concept>
<concept>
<code value="C218640"/>
<display
value="10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)"/>
</concept>
<concept>
<code value="C218641"/>
<display value="10.5.1.4 Sensitivity Analysis"/>
</concept>
<concept>
<code value="C218642"/>
<display value="10.5.1.5 Supplementary Analysis"/>
</concept>
<concept>
<code value="C218643"/>
<display
value="10.6 Analyses Associated with the Exploratory Objective(s)"/>
</concept>
<concept>
<code value="C218644"/>
<display value="10.7 Safety Analyses"/>
</concept>
<concept>
<code value="C218645"/>
<display value="10.8 Other Analyses"/>
</concept>
<concept>
<code value="C218646"/>
<display value="10.9 Interim Analyses"/>
</concept>
<concept>
<code value="C218647"/>
<display value="10.10 Multiplicity Adjustments"/>
</concept>
<concept>
<code value="C218648"/>
<display value="10.11 Sample Size Determination"/>
</concept>
<concept>
<code value="C218649"/>
<display value="11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS"/>
</concept>
<concept>
<code value="C218650"/>
<display value="11.1 Regulatory and Ethical Considerations"/>
</concept>
<concept>
<code value="C218651"/>
<display value="11.2 Trial Oversight"/>
</concept>
<concept>
<code value="C218652"/>
<display value="11.2.1 Investigator Responsibilities"/>
</concept>
<concept>
<code value="C218653"/>
<display value="11.2.2 Sponsor Responsibilities"/>
</concept>
<concept>
<code value="C218654"/>
<display value="11.3 Informed Consent Process"/>
</concept>
<concept>
<code value="C218655"/>
<display value="11.3.1 Informed Consent for Rescreening"/>
</concept>
<concept>
<code value="C218656"/>
<display
value="11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research"/>
</concept>
<concept>
<code value="C218657"/>
<display value="11.4 Committees"/>
</concept>
<concept>
<code value="C218658"/>
<display value="11.5 Insurance and Indemnity"/>
</concept>
<concept>
<code value="C218659"/>
<display value="11.6 Risk-Based Quality Management"/>
</concept>
<concept>
<code value="C218660"/>
<display value="11.7 Data Governance"/>
</concept>
<concept>
<code value="C218661"/>
<display value="11.8 Data Protection"/>
</concept>
<concept>
<code value="C218662"/>
<display value="11.9 Source Data"/>
</concept>
<concept>
<code value="C218663"/>
<display value="11.10 Protocol Deviations"/>
</concept>
<concept>
<code value="C218664"/>
<display value="11.11 Early Site Closure"/>
</concept>
<concept>
<code value="C218665"/>
<display value="11.12 Data Dissemination"/>
</concept>
<concept>
<code value="C218666"/>
<display value="12 APPENDIX: SUPPORTING DETAILS"/>
</concept>
<concept>
<code value="C218667"/>
<display value="12.1 Clinical Laboratory Tests"/>
</concept>
<concept>
<code value="C218668"/>
<display value="12.2 Country/Region-Specific Differences"/>
</concept>
<concept>
<code value="C218669"/>
<display value="12.3 Prior Protocol Amendment(s)"/>
</concept>
<concept>
<code value="C218670"/>
<display value="13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS"/>
</concept>
<concept>
<code value="C218671"/>
<display value="14 APPENDIX: REFERENCES"/>
</concept>
</include>
</compose>
</ValueSet>
IG © 2025+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharmaceutical-research-protocol#1.0.0-ballot based on FHIR 6.0.0-ballot3. Generated 2025-08-01
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