{
  "description": "Codes representing sections of M11.",
  "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"
      } ]
    } ]
  },
  "_filename": "ValueSet-m11-section-codes-vs.json",
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  "date": "2025-08-01T12:18:30+00:00",
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