FHIR IG Statistics: ValueSet/m11-section-codes-vs
Resources that use this resource
Resources that this resource uses
Narrative
Note: links and images are rebased to the (stated) source
- Include these codes as defined in
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl| Code | Display |
| C218514 | 1 PROTOCOL SUMMARY |
| C218515 | 1.1 Protocol Synopsis |
| C218516 | 1.1.1 Primary and Secondary Objectives and Estimands |
| C218517 | 1.1.2 Overall Design |
| C218518 | 1.2 Trial Schema |
| C218519 | 1.3 Schedule of Activities |
| C218520 | 2 INTRODUCTION |
| C218521 | 2.1 Purpose of Trial |
| C218522 | 2.2 Assessment of Risks and Benefits |
| C218523 | 2.2.1 Risk Summary and Mitigation Strategy |
| C218524 | 2.2.2 Benefit Summary |
| C218525 | 2.2.3 Overall Risk-Benefit Assessment |
| C218526 | 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS |
| C218527 | 3.1 Primary Objective(s) and Associated Estimand(s) |
| C218528 | 3.1.1 Primary Objective |
| C218529 | 3.2 Secondary Objective(s) and Associated Estimand(s) |
| C218530 | 3.2.1 Secondary Objective |
| C218531 | 3.3 Exploratory Objective(s) |
| C218532 | 3.3.1 Exploratory Objective |
| C218533 | 4 TRIAL DESIGN |
| C218534 | 4.1 Description of Trial Design |
| C218535 | 4.1.1 Stakeholder Input into Design |
| C218536 | 4.2 Rationale for Trial Design |
| C218537 | 4.2.1 Rationale for Estimand(s) |
| C218538 | 4.2.2 Rationale for Intervention Model |
| C218539 | 4.2.3 Rationale for Control Type |
| C218540 | 4.2.4 Rationale for Trial Duration |
| C218541 | 4.2.5 Rationale for Adaptive or Novel Trial Design |
| C218542 | 4.2.6 Rationale for Interim Analysis |
| C218543 | 4.2.7 Rationale for Other Trial Design Aspects |
| C218544 | 4.3 Trial Stopping Rules |
| C218545 | 4.4 Start of Trial and End of Trial |
| C218546 | 4.5 Access to Trial Intervention After End of Trial |
| C218547 | 5 TRIAL POPULATION |
| C218548 | 5.1 Description of Trial Population and Rationale |
| C218549 | 5.2 Inclusion Criteria |
| C218550 | 5.3 Exclusion Criteria |
| C218551 | 5.4 Contraception |
| C218552 | 5.4.1 Definitions Related to Childbearing Potential |
| C218553 | 5.4.2 Contraception Requirements |
| C218554 | 5.5 Lifestyle Restrictions |
| C218555 | 5.5.1 Meals and Dietary Restrictions |
| C218556 | 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions |
| C218557 | 5.5.3 Physical Activity Restrictions |
| C218558 | 5.5.4 Other Activity Restrictions |
| C218559 | 5.6 Screen Failure and Rescreening |
| C218560 | 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY |
| C218561 | 6.1 Description of Investigational Trial Intervention |
| C218562 | 6.2 Rationale for Investigational Trial Intervention Dose and Regimen |
| C218563 | 6.3 Investigational Trial Intervention Administration |
| C218564 | 6.4 Investigational Trial Intervention Dose Modification |
| C218565 | 6.5 Management of Investigational Trial Intervention Overdose |
| C218566 | 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention |
| C218567 | 6.6.1 Preparation of Investigational Trial Intervention |
| C218568 | 6.6.2 Storage and Handling of Investigational Trial Intervention |
| C218569 | 6.6.3 Accountability of Investigational Trial Intervention |
| C218570 | 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding |
| C218571 | 6.7.1 Participant Assignment to Investigational Trial Intervention |
| C218572 | 6.7.2 Randomisation |
| C218573 | 6.7.3 Measures to Maintain Blinding |
| C218574 | 6.7.4 Emergency Unblinding at the Site |
| C218575 | 6.8 Investigational Trial Intervention Adherence |
| C218576 | 6.9 Description of Noninvestigational Trial Intervention |
| C218577 | 6.9.1 Background Trial Intervention |
| C218578 | 6.9.2 Rescue Therapy |
| C218579 | 6.9.3 Other Noninvestigational Trial Intervention |
| C218580 | 6.10 Concomitant Therapy |
| C218581 | 6.10.1 Prohibited Concomitant Therapy |
| C218582 | 6.10.2 Permitted Concomitant Therapy |
| C218583 | 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL |
| C218584 | 7.1 Discontinuation of Trial Intervention for Individual Participants |
| C218585 | 7.1.1 Permanent Discontinuation of Trial Intervention |
| C218586 | 7.1.2 Temporary Discontinuation of Trial Intervention |
| C218587 | 7.1.3 Rechallenge |
| C218588 | 7.2 Participant Discontinuation or Withdrawal from the Trial |
| C218589 | 7.3 Management of Loss to Follow-Up |
| C218590 | 8 TRIAL ASSESSMENTS AND PROCEDURES |
| C218591 | 8.1 Trial Assessments and Procedures Considerations |
| C218592 | 8.2 Screening/Baseline Assessments and Procedures |
| C218593 | 8.3 Efficacy Assessments and Procedures |
| C218594 | 8.4 Safety Assessments and Procedures |
| C218595 | 8.4.1 Physical Examination |
| C218596 | 8.4.2 Vital Signs |
| C218597 | 8.4.3 Electrocardiograms |
| C218598 | 8.4.4 Clinical Laboratory Assessments |
| C218599 | 8.4.5 Pregnancy Testing |
| C218600 | 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring |
| C218601 | 8.5 Pharmacokinetics |
| C218602 | 8.6 Biomarkers |
| C218603 | 8.6.1 Genetics and Pharmacogenomics |
| C218604 | 8.6.2 Pharmacodynamic Biomarkers |
| C218605 | 8.6.3 Other Biomarkers |
| C218606 | 8.7 Immunogenicity Assessments |
| C218607 | 8.8 Medical Resource Utilisation and Health Economics |
| C218608 | 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS |
| C218609 | 9.1 Definitions |
| C218610 | 9.1.1 Definitions of Adverse Events |
| C218611 | 9.1.2 Definitions of Serious Adverse Events |
| C218612 | 9.1.3 Definitions of Product Complaints |
| C218613 | 9.1.3.1 Definition of Medical Device Product Complaints |
| C218614 | 9.2 Timing and Procedures for Collection and Reporting |
| C218615 | 9.2.1 Timing |
| C218616 | 9.2.2 Collection Procedures |
| C218617 | 9.2.3 Reporting |
| C218618 | 9.2.3.1 Regulatory Reporting Requirements |
| C218619 | 9.2.4 Adverse Events of Special Interest |
| C218620 | 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs |
| C218621 | 9.3 Pregnancy and Postpartum Information |
| C218622 | 9.3.1 Participants Who Become Pregnant During the Trial |
| C218623 | 9.3.2 Participants Whose Partners Become Pregnant During the Trial |
| C218624 | 9.4 Special Safety Situations |
| C218625 | 10 STATISTICAL CONSIDERATIONS |
| C218626 | 10.1 General Considerations |
| C218627 | 10.2 Analysis Sets |
| C218628 | 10.3 Analyses of Demographics and Other Baseline Variables |
| C218629 | 10.4 Analyses Associated with the Primary Objective(s) |
| C218630 | 10.4.1 Primary Objective |
| C218631 | 10.4.1.1 Statistical Analysis Method |
| C218632 | 10.4.1.2 Handling of Data in Relation to Primary Estimand(s) |
| C218633 | 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s) |
| C218634 | 10.4.1.4 Sensitivity Analysis |
| C218635 | 10.4.1.5 Supplementary Analysis |
| C218636 | 10.5 Analyses Associated with the Secondary Objective(s) |
| C218637 | 10.5.1 Secondary Objective |
| C218638 | 10.5.1.1 Statistical Analysis Method |
| C218639 | 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s) |
| C218640 | 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s) |
| C218641 | 10.5.1.4 Sensitivity Analysis |
| C218642 | 10.5.1.5 Supplementary Analysis |
| C218643 | 10.6 Analyses Associated with the Exploratory Objective(s) |
| C218644 | 10.7 Safety Analyses |
| C218645 | 10.8 Other Analyses |
| C218646 | 10.9 Interim Analyses |
| C218647 | 10.10 Multiplicity Adjustments |
| C218648 | 10.11 Sample Size Determination |
| C218649 | 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS |
| C218650 | 11.1 Regulatory and Ethical Considerations |
| C218651 | 11.2 Trial Oversight |
| C218652 | 11.2.1 Investigator Responsibilities |
| C218653 | 11.2.2 Sponsor Responsibilities |
| C218654 | 11.3 Informed Consent Process |
| C218655 | 11.3.1 Informed Consent for Rescreening |
| C218656 | 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research |
| C218657 | 11.4 Committees |
| C218658 | 11.5 Insurance and Indemnity |
| C218659 | 11.6 Risk-Based Quality Management |
| C218660 | 11.7 Data Governance |
| C218661 | 11.8 Data Protection |
| C218662 | 11.9 Source Data |
| C218663 | 11.10 Protocol Deviations |
| C218664 | 11.11 Early Site Closure |
| C218665 | 11.12 Data Dissemination |
| C218666 | 12 APPENDIX: SUPPORTING DETAILS |
| C218667 | 12.1 Clinical Laboratory Tests |
| C218668 | 12.2 Country/Region-Specific Differences |
| C218669 | 12.3 Prior Protocol Amendment(s) |
| C218670 | 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS |
| C218671 | 14 APPENDIX: REFERENCES |
Source
{
"resourceType": "ValueSet",
"id": "m11-section-codes-vs",
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative",
"_valueCode": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ImplementationGuide/hl7.fhir.uv.pharmaceutical-research-protocol"
}
]
}
}
],
"url": "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs",
"version": "0.5.0",
"name": "M11SectionCodesVS",
"title": "M11 Section Codes Value Set",
"status": "draft",
"experimental": true,
"date": "2025-07-22T21:24:53+00:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
"contact": [
{
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org/Special/committees/rcrim"
},
{
"system": "email",
"value": "UDP@HL7Vulcan.org"
}
]
}
],
"description": "Codes representing sections of M11.",
"jurisdiction": [
{
"coding": [
{
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code": "001",
"display": "World"
}
]
}
],
"compose": {
"include": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"concept": [
{
"code": "C218514",
"display": "1 PROTOCOL SUMMARY"
},
{
"code": "C218515",
"display": "1.1 Protocol Synopsis"
},
{
"code": "C218516",
"display": "1.1.1 Primary and Secondary Objectives and Estimands"
},
{
"code": "C218517",
"display": "1.1.2 Overall Design"
},
{
"code": "C218518",
"display": "1.2 Trial Schema"
},
{
"code": "C218519",
"display": "1.3 Schedule of Activities"
},
{
"code": "C218520",
"display": "2 INTRODUCTION"
},
{
"code": "C218521",
"display": "2.1 Purpose of Trial"
},
{
"code": "C218522",
"display": "2.2 Assessment of Risks and Benefits"
},
{
"code": "C218523",
"display": "2.2.1 Risk Summary and Mitigation Strategy"
},
{
"code": "C218524",
"display": "2.2.2 Benefit Summary"
},
{
"code": "C218525",
"display": "2.2.3 Overall Risk-Benefit Assessment"
},
{
"code": "C218526",
"display": "3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS"
},
{
"code": "C218527",
"display": "3.1 Primary Objective(s) and Associated Estimand(s)"
},
{
"code": "C218528",
"display": "3.1.1 Primary Objective"
},
{
"code": "C218529",
"display": "3.2 Secondary Objective(s) and Associated Estimand(s)"
},
{
"code": "C218530",
"display": "3.2.1 Secondary Objective"
},
{
"code": "C218531",
"display": "3.3 Exploratory Objective(s)"
},
{
"code": "C218532",
"display": "3.3.1 Exploratory Objective"
},
{
"code": "C218533",
"display": "4 TRIAL DESIGN"
},
{
"code": "C218534",
"display": "4.1 Description of Trial Design"
},
{
"code": "C218535",
"display": "4.1.1 Stakeholder Input into Design"
},
{
"code": "C218536",
"display": "4.2 Rationale for Trial Design"
},
{
"code": "C218537",
"display": "4.2.1 Rationale for Estimand(s)"
},
{
"code": "C218538",
"display": "4.2.2 Rationale for Intervention Model"
},
{
"code": "C218539",
"display": "4.2.3 Rationale for Control Type"
},
{
"code": "C218540",
"display": "4.2.4 Rationale for Trial Duration"
},
{
"code": "C218541",
"display": "4.2.5 Rationale for Adaptive or Novel Trial Design"
},
{
"code": "C218542",
"display": "4.2.6 Rationale for Interim Analysis"
},
{
"code": "C218543",
"display": "4.2.7 Rationale for Other Trial Design Aspects"
},
{
"code": "C218544",
"display": "4.3 Trial Stopping Rules"
},
{
"code": "C218545",
"display": "4.4 Start of Trial and End of Trial"
},
{
"code": "C218546",
"display": "4.5 Access to Trial Intervention After End of Trial"
},
{
"code": "C218547",
"display": "5 TRIAL POPULATION"
},
{
"code": "C218548",
"display": "5.1 Description of Trial Population and Rationale"
},
{
"code": "C218549",
"display": "5.2 Inclusion Criteria"
},
{
"code": "C218550",
"display": "5.3 Exclusion Criteria"
},
{
"code": "C218551",
"display": "5.4 Contraception"
},
{
"code": "C218552",
"display": "5.4.1 Definitions Related to Childbearing Potential"
},
{
"code": "C218553",
"display": "5.4.2 Contraception Requirements"
},
{
"code": "C218554",
"display": "5.5 Lifestyle Restrictions"
},
{
"code": "C218555",
"display": "5.5.1 Meals and Dietary Restrictions"
},
{
"code": "C218556",
"display": "5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions"
},
{
"code": "C218557",
"display": "5.5.3 Physical Activity Restrictions"
},
{
"code": "C218558",
"display": "5.5.4 Other Activity Restrictions"
},
{
"code": "C218559",
"display": "5.6 Screen Failure and Rescreening"
},
{
"code": "C218560",
"display": "6 TRIAL INTERVENTION AND CONCOMITANT THERAPY"
},
{
"code": "C218561",
"display": "6.1 Description of Investigational Trial Intervention"
},
{
"code": "C218562",
"display": "6.2 Rationale for Investigational Trial Intervention Dose and Regimen"
},
{
"code": "C218563",
"display": "6.3 Investigational Trial Intervention Administration"
},
{
"code": "C218564",
"display": "6.4 Investigational Trial Intervention Dose Modification"
},
{
"code": "C218565",
"display": "6.5 Management of Investigational Trial Intervention Overdose"
},
{
"code": "C218566",
"display": "6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention"
},
{
"code": "C218567",
"display": "6.6.1 Preparation of Investigational Trial Intervention"
},
{
"code": "C218568",
"display": "6.6.2 Storage and Handling of Investigational Trial Intervention"
},
{
"code": "C218569",
"display": "6.6.3 Accountability of Investigational Trial Intervention"
},
{
"code": "C218570",
"display": "6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding"
},
{
"code": "C218571",
"display": "6.7.1 Participant Assignment to Investigational Trial Intervention"
},
{
"code": "C218572",
"display": "6.7.2 Randomisation"
},
{
"code": "C218573",
"display": "6.7.3 Measures to Maintain Blinding"
},
{
"code": "C218574",
"display": "6.7.4 Emergency Unblinding at the Site"
},
{
"code": "C218575",
"display": "6.8 Investigational Trial Intervention Adherence"
},
{
"code": "C218576",
"display": "6.9 Description of Noninvestigational Trial Intervention"
},
{
"code": "C218577",
"display": "6.9.1 Background Trial Intervention"
},
{
"code": "C218578",
"display": "6.9.2 Rescue Therapy"
},
{
"code": "C218579",
"display": "6.9.3 Other Noninvestigational Trial Intervention"
},
{
"code": "C218580",
"display": "6.10 Concomitant Therapy"
},
{
"code": "C218581",
"display": "6.10.1 Prohibited Concomitant Therapy"
},
{
"code": "C218582",
"display": "6.10.2 Permitted Concomitant Therapy"
},
{
"code": "C218583",
"display": "7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL"
},
{
"code": "C218584",
"display": "7.1 Discontinuation of Trial Intervention for Individual Participants"
},
{
"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"
}
]
}
]
}
}
FHIR