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" : "<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" : "1 PROTOCOL SUMMARY"
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"code" : "C218585",
"display" : "7.1.1 Permanent Discontinuation of Trial Intervention"
},
{
"code" : "C218586",
"display" : "7.1.2 Temporary Discontinuation of Trial Intervention"
},
{
"code" : "C218587",
"display" : "7.1.3 Rechallenge"
},
{
"code" : "C218588",
"display" : "7.2 Participant Discontinuation or Withdrawal from the Trial"
},
{
"code" : "C218589",
"display" : "7.3 Management of Loss to Follow-Up"
},
{
"code" : "C218590",
"display" : "8 TRIAL ASSESSMENTS AND PROCEDURES"
},
{
"code" : "C218591",
"display" : "8.1 Trial Assessments and Procedures Considerations"
},
{
"code" : "C218592",
"display" : "8.2 Screening/Baseline Assessments and Procedures"
},
{
"code" : "C218593",
"display" : "8.3 Efficacy Assessments and Procedures"
},
{
"code" : "C218594",
"display" : "8.4 Safety Assessments and Procedures"
},
{
"code" : "C218595",
"display" : "8.4.1 Physical Examination"
},
{
"code" : "C218596",
"display" : "8.4.2 Vital Signs"
},
{
"code" : "C218597",
"display" : "8.4.3 Electrocardiograms"
},
{
"code" : "C218598",
"display" : "8.4.4 Clinical Laboratory Assessments"
},
{
"code" : "C218599",
"display" : "8.4.5 Pregnancy Testing"
},
{
"code" : "C218600",
"display" : "8.4.6 Suicidal Ideation and Behaviour Risk Monitoring"
},
{
"code" : "C218601",
"display" : "8.5 Pharmacokinetics"
},
{
"code" : "C218602",
"display" : "8.6 Biomarkers"
},
{
"code" : "C218603",
"display" : "8.6.1 Genetics and Pharmacogenomics"
},
{
"code" : "C218604",
"display" : "8.6.2 Pharmacodynamic Biomarkers"
},
{
"code" : "C218605",
"display" : "8.6.3 Other Biomarkers"
},
{
"code" : "C218606",
"display" : "8.7 Immunogenicity Assessments"
},
{
"code" : "C218607",
"display" : "8.8 Medical Resource Utilisation and Health Economics"
},
{
"code" : "C218608",
"display" : "9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS"
},
{
"code" : "C218609",
"display" : "9.1 Definitions"
},
{
"code" : "C218610",
"display" : "9.1.1 Definitions of Adverse Events"
},
{
"code" : "C218611",
"display" : "9.1.2 Definitions of Serious Adverse Events"
},
{
"code" : "C218612",
"display" : "9.1.3 Definitions of Product Complaints"
},
{
"code" : "C218613",
"display" : "9.1.3.1 Definition of Medical Device Product Complaints"
},
{
"code" : "C218614",
"display" : "9.2 Timing and Procedures for Collection and Reporting"
},
{
"code" : "C218615",
"display" : "9.2.1 Timing"
},
{
"code" : "C218616",
"display" : "9.2.2 Collection Procedures"
},
{
"code" : "C218617",
"display" : "9.2.3 Reporting"
},
{
"code" : "C218618",
"display" : "9.2.3.1 Regulatory Reporting Requirements"
},
{
"code" : "C218619",
"display" : "9.2.4 Adverse Events of Special Interest"
},
{
"code" : "C218620",
"display" : "9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs"
},
{
"code" : "C218621",
"display" : "9.3 Pregnancy and Postpartum Information"
},
{
"code" : "C218622",
"display" : "9.3.1 Participants Who Become Pregnant During the Trial"
},
{
"code" : "C218623",
"display" : "9.3.2 Participants Whose Partners Become Pregnant During the Trial"
},
{
"code" : "C218624",
"display" : "9.4 Special Safety Situations"
},
{
"code" : "C218625",
"display" : "10 STATISTICAL CONSIDERATIONS"
},
{
"code" : "C218626",
"display" : "10.1 General Considerations"
},
{
"code" : "C218627",
"display" : "10.2 Analysis Sets"
},
{
"code" : "C218628",
"display" : "10.3 Analyses of Demographics and Other Baseline Variables"
},
{
"code" : "C218629",
"display" : "10.4 Analyses Associated with the Primary Objective(s)"
},
{
"code" : "C218630",
"display" : "10.4.1 Primary Objective"
},
{
"code" : "C218631",
"display" : "10.4.1.1 Statistical Analysis Method"
},
{
"code" : "C218632",
"display" : "10.4.1.2 Handling of Data in Relation to Primary Estimand(s)"
},
{
"code" : "C218633",
"display" : "10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)"
},
{
"code" : "C218634",
"display" : "10.4.1.4 Sensitivity Analysis"
},
{
"code" : "C218635",
"display" : "10.4.1.5 Supplementary Analysis"
},
{
"code" : "C218636",
"display" : "10.5 Analyses Associated with the Secondary Objective(s)"
},
{
"code" : "C218637",
"display" : "10.5.1 Secondary Objective"
},
{
"code" : "C218638",
"display" : "10.5.1.1 Statistical Analysis Method"
},
{
"code" : "C218639",
"display" : "10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)"
},
{
"code" : "C218640",
"display" : "10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)"
},
{
"code" : "C218641",
"display" : "10.5.1.4 Sensitivity Analysis"
},
{
"code" : "C218642",
"display" : "10.5.1.5 Supplementary Analysis"
},
{
"code" : "C218643",
"display" : "10.6 Analyses Associated with the Exploratory Objective(s)"
},
{
"code" : "C218644",
"display" : "10.7 Safety Analyses"
},
{
"code" : "C218645",
"display" : "10.8 Other Analyses"
},
{
"code" : "C218646",
"display" : "10.9 Interim Analyses"
},
{
"code" : "C218647",
"display" : "10.10 Multiplicity Adjustments"
},
{
"code" : "C218648",
"display" : "10.11 Sample Size Determination"
},
{
"code" : "C218649",
"display" : "11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS"
},
{
"code" : "C218650",
"display" : "11.1 Regulatory and Ethical Considerations"
},
{
"code" : "C218651",
"display" : "11.2 Trial Oversight"
},
{
"code" : "C218652",
"display" : "11.2.1 Investigator Responsibilities"
},
{
"code" : "C218653",
"display" : "11.2.2 Sponsor Responsibilities"
},
{
"code" : "C218654",
"display" : "11.3 Informed Consent Process"
},
{
"code" : "C218655",
"display" : "11.3.1 Informed Consent for Rescreening"
},
{
"code" : "C218656",
"display" : "11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research"
},
{
"code" : "C218657",
"display" : "11.4 Committees"
},
{
"code" : "C218658",
"display" : "11.5 Insurance and Indemnity"
},
{
"code" : "C218659",
"display" : "11.6 Risk-Based Quality Management"
},
{
"code" : "C218660",
"display" : "11.7 Data Governance"
},
{
"code" : "C218661",
"display" : "11.8 Data Protection"
},
{
"code" : "C218662",
"display" : "11.9 Source Data"
},
{
"code" : "C218663",
"display" : "11.10 Protocol Deviations"
},
{
"code" : "C218664",
"display" : "11.11 Early Site Closure"
},
{
"code" : "C218665",
"display" : "11.12 Data Dissemination"
},
{
"code" : "C218666",
"display" : "12 APPENDIX: SUPPORTING DETAILS"
},
{
"code" : "C218667",
"display" : "12.1 Clinical Laboratory Tests"
},
{
"code" : "C218668",
"display" : "12.2 Country/Region-Specific Differences"
},
{
"code" : "C218669",
"display" : "12.3 Prior Protocol Amendment(s)"
},
{
"code" : "C218670",
"display" : "13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS"
},
{
"code" : "C218671",
"display" : "14 APPENDIX: REFERENCES"
}
]
}
]
}
}
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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