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 |
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:ValueSet ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "m11-section-codes-vs"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir: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>"^^rdf:XMLLiteral ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ] ; fhir:value [ a fhir:integer ; fhir:v 2 ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "brr" ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "trial-use" ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ] ; fhir:value [ a fhir:canonical ; fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol> ] ] ) ] ] ) ; # fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs"^^xsd:anyURI] ; # fhir:version [ fhir:v "1.0.0-ballot"] ; # fhir:name [ fhir:v "M11SectionCodesVS"] ; # fhir:title [ fhir:v "M11 Section Codes Value Set"] ; # fhir:status [ fhir:v "draft"] ; # fhir:experimental [ fhir:v false] ; # fhir:date [ fhir:v "2025-08-01T12:18:30+00:00"^^xsd:dateTime] ; # fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; # fhir:contact ( [ fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ; ( fhir:telecom [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ] ] [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "UDP@HL7Vulcan.org" ] ] ) ] ) ; # fhir:description [ fhir:v "Codes representing sections of M11."] ; # fhir:jurisdiction ( [ ( fhir:coding [ fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ] ; fhir:code [ fhir:v "001" ] ; fhir:display [ fhir:v "World" ] ] ) ] ) ; # fhir:compose [ ( fhir:include [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; ( fhir:concept [ fhir:code [ fhir:v "C218514" ] ; fhir:display [ fhir:v "1 PROTOCOL SUMMARY" ] ] [ fhir:code [ fhir:v "C218515" ] ; fhir:display [ fhir:v "1.1 Protocol Synopsis" ] ] [ fhir:code [ fhir:v "C218516" ] ; fhir:display [ fhir:v "1.1.1 Primary and Secondary Objectives and Estimands" ] ] [ fhir:code [ fhir:v "C218517" ] ; fhir:display [ fhir:v "1.1.2 Overall Design" ] ] [ fhir:code [ fhir:v "C218518" ] ; fhir:display [ fhir:v "1.2 Trial Schema" ] ] [ fhir:code [ fhir:v "C218519" ] ; fhir:display [ fhir:v "1.3 Schedule of Activities" ] ] [ fhir:code [ fhir:v "C218520" ] ; fhir:display [ fhir:v "2 INTRODUCTION" ] ] [ fhir:code [ fhir:v "C218521" ] ; fhir:display [ fhir:v "2.1 Purpose of Trial" ] ] [ fhir:code [ fhir:v "C218522" ] ; fhir:display [ fhir:v "2.2 Assessment of Risks and Benefits" ] ] [ fhir:code [ fhir:v "C218523" ] ; fhir:display [ fhir:v "2.2.1 Risk Summary and Mitigation Strategy" ] ] [ fhir:code [ fhir:v "C218524" ] ; fhir:display [ fhir:v "2.2.2 Benefit Summary" ] ] [ fhir:code [ fhir:v "C218525" ] ; fhir:display [ fhir:v "2.2.3 Overall Risk-Benefit Assessment" ] ] [ fhir:code [ fhir:v "C218526" ] ; fhir:display [ fhir:v "3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS" ] ] [ fhir:code [ fhir:v "C218527" ] ; fhir:display [ fhir:v "3.1 Primary Objective(s) and Associated Estimand(s)" ] ] [ fhir:code [ fhir:v "C218528" ] ; fhir:display [ fhir:v "3.1.1 Primary Objective" ] ] [ fhir:code [ fhir:v "C218529" ] ; fhir:display [ fhir:v "3.2 Secondary Objective(s) and Associated Estimand(s)" ] ] [ fhir:code [ fhir:v "C218530" ] ; fhir:display [ fhir:v "3.2.1 Secondary Objective" ] ] [ fhir:code [ fhir:v "C218531" ] ; fhir:display [ fhir:v "3.3 Exploratory Objective(s)" ] ] [ fhir:code [ fhir:v "C218532" ] ; fhir:display [ fhir:v "3.3.1 Exploratory Objective" ] ] [ fhir:code [ fhir:v "C218533" ] ; fhir:display [ fhir:v "4 TRIAL DESIGN" ] ] [ fhir:code [ fhir:v "C218534" ] ; fhir:display [ fhir:v "4.1 Description of Trial Design" ] ] [ fhir:code [ fhir:v "C218535" ] ; fhir:display [ fhir:v "4.1.1 Stakeholder Input into Design" ] ] [ fhir:code [ fhir:v "C218536" ] ; fhir:display [ fhir:v "4.2 Rationale for Trial Design" ] ] [ fhir:code [ fhir:v "C218537" ] ; fhir:display [ fhir:v "4.2.1 Rationale for Estimand(s)" ] ] [ fhir:code [ fhir:v "C218538" ] ; fhir:display [ fhir:v "4.2.2 Rationale for Intervention Model" ] ] [ fhir:code [ fhir:v "C218539" ] ; fhir:display [ fhir:v "4.2.3 Rationale for Control Type" ] ] [ fhir:code [ fhir:v "C218540" ] ; fhir:display [ fhir:v "4.2.4 Rationale for Trial Duration" ] ] [ fhir:code [ fhir:v "C218541" ] ; fhir:display [ fhir:v "4.2.5 Rationale for Adaptive or Novel Trial Design" ] ] [ fhir:code [ fhir:v "C218542" ] ; fhir:display [ fhir:v "4.2.6 Rationale for Interim Analysis" ] ] [ fhir:code [ fhir:v "C218543" ] ; fhir:display [ fhir:v "4.2.7 Rationale for Other Trial Design Aspects" ] ] [ fhir:code [ fhir:v "C218544" ] ; fhir:display [ fhir:v "4.3 Trial Stopping Rules" ] ] [ fhir:code [ fhir:v "C218545" ] ; fhir:display [ fhir:v "4.4 Start of Trial and End of Trial" ] ] [ fhir:code [ fhir:v "C218546" ] ; fhir:display [ fhir:v "4.5 Access to Trial Intervention After End of Trial" ] ] [ fhir:code [ fhir:v "C218547" ] ; fhir:display [ fhir:v "5 TRIAL POPULATION" ] ] [ fhir:code [ fhir:v "C218548" ] ; fhir:display [ fhir:v "5.1 Description of Trial Population and Rationale" ] ] [ fhir:code [ fhir:v "C218549" ] ; fhir:display [ fhir:v "5.2 Inclusion Criteria" ] ] [ fhir:code [ fhir:v "C218550" ] ; fhir:display [ fhir:v "5.3 Exclusion Criteria" ] ] [ fhir:code [ fhir:v "C218551" ] ; fhir:display [ fhir:v "5.4 Contraception" ] ] [ fhir:code [ fhir:v "C218552" ] ; fhir:display [ fhir:v "5.4.1 Definitions Related to Childbearing Potential" ] ] [ fhir:code [ fhir:v "C218553" ] ; fhir:display [ fhir:v "5.4.2 Contraception Requirements" ] ] [ fhir:code [ fhir:v "C218554" ] ; fhir:display [ fhir:v "5.5 Lifestyle Restrictions" ] ] [ fhir:code [ fhir:v "C218555" ] ; fhir:display [ fhir:v "5.5.1 Meals and Dietary Restrictions" ] ] [ fhir:code [ fhir:v "C218556" ] ; fhir:display [ fhir:v "5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions" ] ] [ fhir:code [ fhir:v "C218557" ] ; fhir:display [ fhir:v "5.5.3 Physical Activity Restrictions" ] ] [ fhir:code [ fhir:v "C218558" ] ; fhir:display [ fhir:v "5.5.4 Other Activity Restrictions" ] ] [ fhir:code [ fhir:v "C218559" ] ; fhir:display [ fhir:v "5.6 Screen Failure and Rescreening" ] ] [ fhir:code [ fhir:v "C218560" ] ; fhir:display [ fhir:v "6 TRIAL INTERVENTION AND CONCOMITANT THERAPY" ] ] [ fhir:code [ fhir:v "C218561" ] ; fhir:display [ fhir:v "6.1 Description of Investigational Trial Intervention" ] ] [ fhir:code [ fhir:v "C218562" ] ; fhir:display [ fhir:v "6.2 Rationale for Investigational Trial Intervention Dose and Regimen" ] ] [ fhir:code [ fhir:v "C218563" ] ; fhir:display [ fhir:v "6.3 Investigational Trial Intervention Administration" ] ] [ fhir:code [ fhir:v "C218564" ] ; fhir:display [ fhir:v "6.4 Investigational Trial Intervention Dose Modification" ] ] [ fhir:code [ fhir:v "C218565" ] ; fhir:display [ fhir:v "6.5 Management of Investigational Trial Intervention Overdose" ] ] [ fhir:code [ fhir:v "C218566" ] ; fhir:display [ fhir:v "6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention" ] ] [ fhir:code [ fhir:v "C218567" ] ; fhir:display [ fhir:v "6.6.1 Preparation of Investigational Trial Intervention" ] ] [ fhir:code [ fhir:v "C218568" ] ; fhir:display [ fhir:v "6.6.2 Storage and Handling of Investigational Trial Intervention" ] ] [ fhir:code [ fhir:v "C218569" ] ; fhir:display [ fhir:v "6.6.3 Accountability of Investigational Trial Intervention" ] ] [ fhir:code [ fhir:v "C218570" ] ; fhir:display [ fhir:v "6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding" ] ] [ fhir:code [ fhir:v "C218571" ] ; fhir:display [ fhir:v "6.7.1 Participant Assignment to Investigational Trial Intervention" ] ] [ fhir:code [ fhir:v "C218572" ] ; fhir:display [ fhir:v "6.7.2 Randomisation" ] ] [ fhir:code [ fhir:v "C218573" ] ; fhir:display [ fhir:v "6.7.3 Measures to Maintain Blinding" ] ] [ fhir:code [ fhir:v "C218574" ] ; fhir:display [ fhir:v "6.7.4 Emergency Unblinding at the Site" ] ] [ fhir:code [ fhir:v "C218575" ] ; fhir:display [ fhir:v "6.8 Investigational Trial Intervention Adherence" ] ] [ fhir:code [ fhir:v "C218576" ] ; fhir:display [ fhir:v "6.9 Description of Noninvestigational Trial Intervention" ] ] [ fhir:code [ fhir:v "C218577" ] ; fhir:display [ fhir:v "6.9.1 Background Trial Intervention" ] ] [ fhir:code [ fhir:v "C218578" ] ; fhir:display [ fhir:v "6.9.2 Rescue Therapy" ] ] [ fhir:code [ fhir:v "C218579" ] ; fhir:display [ fhir:v "6.9.3 Other Noninvestigational Trial Intervention" ] ] [ fhir:code [ fhir:v "C218580" ] ; fhir:display [ fhir:v "6.10 Concomitant Therapy" ] ] [ fhir:code [ fhir:v "C218581" ] ; fhir:display [ fhir:v "6.10.1 Prohibited Concomitant Therapy" ] ] [ fhir:code [ fhir:v "C218582" ] ; fhir:display [ fhir:v "6.10.2 Permitted Concomitant Therapy" ] ] [ fhir:code [ fhir:v "C218583" ] ; fhir:display [ fhir:v "7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL" ] ] [ fhir:code [ fhir:v "C218584" ] ; fhir:display [ fhir:v "7.1 Discontinuation of Trial Intervention for Individual Participants" ] ] [ fhir:code [ fhir:v "C218585" ] ; fhir:display [ fhir:v "7.1.1 Permanent Discontinuation of Trial Intervention" ] ] [ fhir:code [ fhir:v "C218586" ] ; fhir:display [ fhir:v "7.1.2 Temporary Discontinuation of Trial Intervention" ] ] [ fhir:code [ fhir:v "C218587" ] ; fhir:display [ fhir:v "7.1.3 Rechallenge" ] ] [ fhir:code [ fhir:v "C218588" ] ; fhir:display [ fhir:v "7.2 Participant Discontinuation or Withdrawal from the Trial" ] ] [ fhir:code [ fhir:v "C218589" ] ; fhir:display [ fhir:v "7.3 Management of Loss to Follow-Up" ] ] [ fhir:code [ fhir:v "C218590" ] ; fhir:display [ fhir:v "8 TRIAL ASSESSMENTS AND PROCEDURES" ] ] [ fhir:code [ fhir:v "C218591" ] ; fhir:display [ fhir:v "8.1 Trial Assessments and Procedures Considerations" ] ] [ fhir:code [ fhir:v "C218592" ] ; fhir:display [ fhir:v "8.2 Screening/Baseline Assessments and Procedures" ] ] [ fhir:code [ fhir:v "C218593" ] ; fhir:display [ fhir:v "8.3 Efficacy Assessments and Procedures" ] ] [ fhir:code [ fhir:v "C218594" ] ; fhir:display [ fhir:v "8.4 Safety Assessments and Procedures" ] ] [ fhir:code [ fhir:v "C218595" ] ; fhir:display [ fhir:v "8.4.1 Physical Examination" ] ] [ fhir:code [ fhir:v "C218596" ] ; fhir:display [ fhir:v "8.4.2 Vital Signs" ] ] [ fhir:code [ fhir:v "C218597" ] ; fhir:display [ fhir:v "8.4.3 Electrocardiograms" ] ] [ fhir:code [ fhir:v "C218598" ] ; fhir:display [ fhir:v "8.4.4 Clinical Laboratory Assessments" ] ] [ fhir:code [ fhir:v "C218599" ] ; fhir:display [ fhir:v "8.4.5 Pregnancy Testing" ] ] [ fhir:code [ fhir:v "C218600" ] ; fhir:display [ fhir:v "8.4.6 Suicidal Ideation and Behaviour Risk Monitoring" ] ] [ fhir:code [ fhir:v "C218601" ] ; fhir:display [ fhir:v "8.5 Pharmacokinetics" ] ] [ fhir:code [ fhir:v "C218602" ] ; fhir:display [ fhir:v "8.6 Biomarkers" ] ] [ fhir:code [ fhir:v "C218603" ] ; fhir:display [ fhir:v "8.6.1 Genetics and Pharmacogenomics" ] ] [ fhir:code [ fhir:v "C218604" ] ; fhir:display [ fhir:v "8.6.2 Pharmacodynamic Biomarkers" ] ] [ fhir:code [ fhir:v "C218605" ] ; fhir:display [ fhir:v "8.6.3 Other Biomarkers" ] ] [ fhir:code [ fhir:v "C218606" ] ; fhir:display [ fhir:v "8.7 Immunogenicity Assessments" ] ] [ fhir:code [ fhir:v "C218607" ] ; fhir:display [ fhir:v "8.8 Medical Resource Utilisation and Health Economics" ] ] [ fhir:code [ fhir:v "C218608" ] ; fhir:display [ fhir:v "9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS" ] ] [ fhir:code [ fhir:v "C218609" ] ; fhir:display [ fhir:v "9.1 Definitions" ] ] [ fhir:code [ fhir:v "C218610" ] ; fhir:display [ fhir:v "9.1.1 Definitions of Adverse Events" ] ] [ fhir:code [ fhir:v "C218611" ] ; fhir:display [ fhir:v "9.1.2 Definitions of Serious Adverse Events" ] ] [ fhir:code [ fhir:v "C218612" ] ; fhir:display [ fhir:v "9.1.3 Definitions of Product Complaints" ] ] [ fhir:code [ fhir:v "C218613" ] ; fhir:display [ fhir:v "9.1.3.1 Definition of Medical Device Product Complaints" ] ] [ fhir:code [ fhir:v "C218614" ] ; fhir:display [ fhir:v "9.2 Timing and Procedures for Collection and Reporting" ] ] [ fhir:code [ fhir:v "C218615" ] ; fhir:display [ fhir:v "9.2.1 Timing" ] ] [ fhir:code [ fhir:v "C218616" ] ; fhir:display [ fhir:v "9.2.2 Collection Procedures" ] ] [ fhir:code [ fhir:v "C218617" ] ; fhir:display [ fhir:v "9.2.3 Reporting" ] ] [ fhir:code [ fhir:v "C218618" ] ; fhir:display [ fhir:v "9.2.3.1 Regulatory Reporting Requirements" ] ] [ fhir:code [ fhir:v "C218619" ] ; fhir:display [ fhir:v "9.2.4 Adverse Events of Special Interest" ] ] [ fhir:code [ fhir:v "C218620" ] ; fhir:display [ fhir:v "9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs" ] ] [ fhir:code [ fhir:v "C218621" ] ; fhir:display [ fhir:v "9.3 Pregnancy and Postpartum Information" ] ] [ fhir:code [ fhir:v "C218622" ] ; fhir:display [ fhir:v "9.3.1 Participants Who Become Pregnant During the Trial" ] ] [ fhir:code [ fhir:v "C218623" ] ; fhir:display [ fhir:v "9.3.2 Participants Whose Partners Become Pregnant During the Trial" ] ] [ fhir:code [ fhir:v "C218624" ] ; fhir:display [ fhir:v "9.4 Special Safety Situations" ] ] [ fhir:code [ fhir:v "C218625" ] ; fhir:display [ fhir:v "10 STATISTICAL CONSIDERATIONS" ] ] [ fhir:code [ fhir:v "C218626" ] ; fhir:display [ fhir:v "10.1 General Considerations" ] ] [ fhir:code [ fhir:v "C218627" ] ; fhir:display [ fhir:v "10.2 Analysis Sets" ] ] [ fhir:code [ fhir:v "C218628" ] ; fhir:display [ fhir:v "10.3 Analyses of Demographics and Other Baseline Variables" ] ] [ fhir:code [ fhir:v "C218629" ] ; fhir:display [ fhir:v "10.4 Analyses Associated with the Primary Objective(s)" ] ] [ fhir:code [ fhir:v "C218630" ] ; fhir:display [ fhir:v "10.4.1 Primary Objective" ] ] [ fhir:code [ fhir:v "C218631" ] ; fhir:display [ fhir:v "10.4.1.1 Statistical Analysis Method" ] ] [ fhir:code [ fhir:v "C218632" ] ; fhir:display [ fhir:v "10.4.1.2 Handling of Data in Relation to Primary Estimand(s)" ] ] [ fhir:code [ fhir:v "C218633" ] ; fhir:display [ fhir:v "10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)" ] ] [ fhir:code [ fhir:v "C218634" ] ; fhir:display [ fhir:v "10.4.1.4 Sensitivity Analysis" ] ] [ fhir:code [ fhir:v "C218635" ] ; fhir:display [ fhir:v "10.4.1.5 Supplementary Analysis" ] ] [ fhir:code [ fhir:v "C218636" ] ; fhir:display [ fhir:v "10.5 Analyses Associated with the Secondary Objective(s)" ] ] [ fhir:code [ fhir:v "C218637" ] ; fhir:display [ fhir:v "10.5.1 Secondary Objective" ] ] [ fhir:code [ fhir:v "C218638" ] ; fhir:display [ fhir:v "10.5.1.1 Statistical Analysis Method" ] ] [ fhir:code [ fhir:v "C218639" ] ; fhir:display [ fhir:v "10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)" ] ] [ fhir:code [ fhir:v "C218640" ] ; fhir:display [ fhir:v "10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)" ] ] [ fhir:code [ fhir:v "C218641" ] ; fhir:display [ fhir:v "10.5.1.4 Sensitivity Analysis" ] ] [ fhir:code [ fhir:v "C218642" ] ; fhir:display [ fhir:v "10.5.1.5 Supplementary Analysis" ] ] [ fhir:code [ fhir:v "C218643" ] ; fhir:display [ fhir:v "10.6 Analyses Associated with the Exploratory Objective(s)" ] ] [ fhir:code [ fhir:v "C218644" ] ; fhir:display [ fhir:v "10.7 Safety Analyses" ] ] [ fhir:code [ fhir:v "C218645" ] ; fhir:display [ fhir:v "10.8 Other Analyses" ] ] [ fhir:code [ fhir:v "C218646" ] ; fhir:display [ fhir:v "10.9 Interim Analyses" ] ] [ fhir:code [ fhir:v "C218647" ] ; fhir:display [ fhir:v "10.10 Multiplicity Adjustments" ] ] [ fhir:code [ fhir:v "C218648" ] ; fhir:display [ fhir:v "10.11 Sample Size Determination" ] ] [ fhir:code [ fhir:v "C218649" ] ; fhir:display [ fhir:v "11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS" ] ] [ fhir:code [ fhir:v "C218650" ] ; fhir:display [ fhir:v "11.1 Regulatory and Ethical Considerations" ] ] [ fhir:code [ fhir:v "C218651" ] ; fhir:display [ fhir:v "11.2 Trial Oversight" ] ] [ fhir:code [ fhir:v "C218652" ] ; fhir:display [ fhir:v "11.2.1 Investigator Responsibilities" ] ] [ fhir:code [ fhir:v "C218653" ] ; fhir:display [ fhir:v "11.2.2 Sponsor Responsibilities" ] ] [ fhir:code [ fhir:v "C218654" ] ; fhir:display [ fhir:v "11.3 Informed Consent Process" ] ] [ fhir:code [ fhir:v "C218655" ] ; fhir:display [ fhir:v "11.3.1 Informed Consent for Rescreening" ] ] [ fhir:code [ fhir:v "C218656" ] ; fhir:display [ fhir:v "11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research" ] ] [ fhir:code [ fhir:v "C218657" ] ; fhir:display [ fhir:v "11.4 Committees" ] ] [ fhir:code [ fhir:v "C218658" ] ; fhir:display [ fhir:v "11.5 Insurance and Indemnity" ] ] [ fhir:code [ fhir:v "C218659" ] ; fhir:display [ fhir:v "11.6 Risk-Based Quality Management" ] ] [ fhir:code [ fhir:v "C218660" ] ; fhir:display [ fhir:v "11.7 Data Governance" ] ] [ fhir:code [ fhir:v "C218661" ] ; fhir:display [ fhir:v "11.8 Data Protection" ] ] [ fhir:code [ fhir:v "C218662" ] ; fhir:display [ fhir:v "11.9 Source Data" ] ] [ fhir:code [ fhir:v "C218663" ] ; fhir:display [ fhir:v "11.10 Protocol Deviations" ] ] [ fhir:code [ fhir:v "C218664" ] ; fhir:display [ fhir:v "11.11 Early Site Closure" ] ] [ fhir:code [ fhir:v "C218665" ] ; fhir:display [ fhir:v "11.12 Data Dissemination" ] ] [ fhir:code [ fhir:v "C218666" ] ; fhir:display [ fhir:v "12 APPENDIX: SUPPORTING DETAILS" ] ] [ fhir:code [ fhir:v "C218667" ] ; fhir:display [ fhir:v "12.1 Clinical Laboratory Tests" ] ] [ fhir:code [ fhir:v "C218668" ] ; fhir:display [ fhir:v "12.2 Country/Region-Specific Differences" ] ] [ fhir:code [ fhir:v "C218669" ] ; fhir:display [ fhir:v "12.3 Prior Protocol Amendment(s)" ] ] [ fhir:code [ fhir:v "C218670" ] ; fhir:display [ fhir:v "13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS" ] ] [ fhir:code [ fhir:v "C218671" ] ; fhir:display [ fhir:v "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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