Sections

The ICH M11 sections (code list C217272), in number order. In brackets: element specifications in the section itself.

• 1 PROTOCOL SUMMARY (0)
  • 1.1 Protocol Synopsis (0)
    • 1.1.1 Primary and Secondary Objectives and Estimands (1)
    • 1.1.2 Overall Design (35)
  • 1.2 Trial Schema (2)
  • 1.3 Schedule of Activities (1)
• 2 INTRODUCTION (0)
  • 2.1 Purpose of Trial (1)
  • 2.2 Assessment of Risks and Benefits (0)
    • 2.2.2 Benefit Summary (3)
    • 2.2.1 Risk Summary and Mitigation Strategy (1)
    • 2.2.3 Overall Risk-Benefit Assessment (1)
• 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS (0)
  • 3.1 Primary Objective(s) and Associated Estimand(s) (7)
    • 3.1.1 Primary Objective (0)
  • 3.2 Secondary Objective(s) and Associated Estimand(s) (7)
    • 3.2.1 Secondary Objective (0)
  • 3.3 Exploratory Objective(s) (7)
    • 3.3.1 Exploratory Objective (0)
• 4 TRIAL DESIGN (0)
  • 4.1 Description of Trial Design (5)
    • 4.1.1 Stakeholder Input into Design (1)
  • 4.2 Rationale for Trial Design (1)
    • 4.2.1 Rationale for Estimand(s) (1)
    • 4.2.2 Rationale for Intervention Model (1)
    • 4.2.3 Rationale for Control Type (1)
    • 4.2.4 Rationale for Trial Duration (1)
    • 4.2.5 Rationale for Adaptive or Novel Trial Design (1)
    • 4.2.6 Rationale for Interim Analysis (1)
    • 4.2.7 Rationale for Other Trial Design Aspects (1)
  • 4.3 Trial Stopping Rules (1)
  • 4.4 Start of Trial and End of Trial (2)
  • 4.5 Access to Trial Intervention After End of Trial (1)
• 5 TRIAL POPULATION (0)
  • 5.1 Description of Trial Population and Rationale (1)
  • 5.2 Inclusion Criteria (1)
  • 5.3 Exclusion Criteria (1)
  • 5.4 Contraception (1)
    • 5.4.1 Definitions Related to Childbearing Potential (1)
    • 5.4.2 Contraception Requirements (0)
  • 5.5 Lifestyle Restrictions (1)
    • 5.5.1 Meals and Dietary Restrictions (1)
    • 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions (1)
    • 5.5.3 Physical Activity Restrictions (1)
    • 5.5.4 Other Activity Restrictions (1)
  • 5.6 Screen Failure and Rescreening (2)
• 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY (13)
  • 6.1 Description of Investigational Trial Intervention (1)
  • 6.2 Rationale for Investigational Trial Intervention Dose and Regimen (1)
  • 6.3 Investigational Trial Intervention Administration (1)
  • 6.4 Investigational Trial Intervention Dose Modification (1)
  • 6.5 Management of Investigational Trial Intervention Overdose (1)
  • 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention (0)
    • 6.6.1 Preparation of Investigational Trial Intervention (1)
    • 6.6.2 Storage and Handling of Investigational Trial Intervention (1)
    • 6.6.3 Accountability of Investigational Trial Intervention (1)
  • 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding (0)
    • 6.7.1 Participant Assignment to Investigational Trial Intervention (1)
    • 6.7.2 Randomisation (1)
    • 6.7.3 Measures to Maintain Blinding (1)
    • 6.7.4 Emergency Unblinding at the Site (1)
  • 6.8 Investigational Trial Intervention Adherence (1)
  • 6.9 Description of Noninvestigational Trial Intervention (1)
    • 6.9.1 Background Trial Intervention (1)
    • 6.9.2 Rescue Therapy (1)
    • 6.9.3 Other Noninvestigational Trial Intervention (1)
  • 6.10 Concomitant Therapy (1)
    • 6.10.1 Prohibited Concomitant Therapy (1)
    • 6.10.2 Permitted Concomitant Therapy (1)
• 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL (0)
  • 7.1 Discontinuation of Trial Intervention for Individual Participants (0)
    • 7.1.1 Permanent Discontinuation of Trial Intervention (1)
    • 7.1.2 Temporary Discontinuation of Trial Intervention (1)
    • 7.1.3 Rechallenge (1)
  • 7.2 Participant Discontinuation or Withdrawal from the Trial (1)
  • 7.3 Management of Loss to Follow-Up (1)
• 8 TRIAL ASSESSMENTS AND PROCEDURES (0)
  • 8.1 Trial Assessments and Procedures Considerations (1)
  • 8.2 Screening/Baseline Assessments and Procedures (2)
  • 8.3 Efficacy Assessments and Procedures (1)
  • 8.4 Safety Assessments and Procedures (1)
    • 8.4.1 Physical Examination (1)
    • 8.4.2 Vital Signs (1)
    • 8.4.3 Electrocardiograms (1)
    • 8.4.4 Clinical Laboratory Assessments (1)
    • 8.4.5 Pregnancy Testing (1)
    • 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring (1)
  • 8.5 Pharmacokinetics (1)
  • 8.6 Biomarkers (0)
    • 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics (1)
    • 8.6.2 Pharmacodynamic Biomarkers (1)
    • 8.6.3 Other Biomarkers (1)
  • 8.7 Immunogenicity Assessments (1)
  • 8.8 Medical Resource Utilisation and Health Economics (1)
• 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS (0)
  • 9.1 Definitions (0)
    • 9.1.1 Definitions of Adverse Events (1)
    • 9.1.2 Definitions of Serious Adverse Events (1)
    • 9.1.3 Definitions of Product Complaints (1)
      • 9.1.3.1 Definitions of Medical Device Product Complaints (1)
  • 9.2 Timing and Procedures for Collection and Reporting (8)
    • 9.2.1 Timing (1)
    • 9.2.2 Collection Procedures (5)
    • 9.2.3 Reporting (1)
      • 9.2.3.1 Regulatory Reporting Requirements (1)
    • 9.2.4 Adverse Events of Special Interest (1)
    • 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs (1)
  • 9.3 Pregnancy and Postpartum Information (0)
    • 9.3.1 Participants Who Become Pregnant During the Trial (1)
    • 9.3.2 Participants Whose Partners Become Pregnant During the Trial (1)
  • 9.4 Special Safety Situations (1)
• 10 STATISTICAL CONSIDERATIONS (0)
  • 10.1 General Considerations (1)
  • 10.2 Analysis Sets (1)
  • 10.3 Analyses of Demographics and Other Baseline Variables (1)
  • 10.4 Analyses Associated with the Primary Objective(s) (5)
    • 10.4.1 Primary Objective (0)
      • 10.4.1.1 Statistical Analysis Method (0)
      • 10.4.1.2 Handling of Data in Relation to Primary Estimand(s) (0)
      • 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s) (0)
      • 10.4.1.4 Sensitivity Analysis (0)
      • 10.4.1.5 Supplementary Analysis (0)
  • 10.5 Analyses Associated with the Secondary Objective(s) (5)
    • 10.5.1 Secondary Objective (0)
      • 10.5.1.1 Statistical Analysis Method (0)
      • 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s) (0)
      • 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s) (0)
      • 10.5.1.4 Sensitivity Analysis (0)
      • 10.5.1.5 Supplementary Analysis (0)
  • 10.6 Analyses Associated with the Exploratory Objective(s) (1)
  • 10.7 Safety Analyses (1)
  • 10.8 Other Analyses (1)
  • 10.9 Interim Analyses (1)
  • 10.10 Multiplicity Adjustments (1)
  • 10.11 Sample Size Determination (1)
• 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS (0)
  • 11.1 Regulatory and Ethical Considerations (1)
  • 11.2 Trial Oversight (1)
    • 11.2.1 Investigator Responsibilities (1)
    • 11.2.2 Sponsor Responsibilities (1)
  • 11.3 Informed Consent Process (3)
    • 11.3.1 Informed Consent for Rescreening (1)
    • 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research (1)
  • 11.4 Committees (1)
  • 11.5 Insurance and Indemnity (1)
  • 11.6 Risk-Based Quality Management (1)
  • 11.7 Data Governance (1)
  • 11.8 Data Protection (1)
  • 11.9 Source Records (4)
  • 11.10 Protocol Deviations (1)
  • 11.11 Early Site Closure (3)
  • 11.12 Data Dissemination (1)
• 12 APPENDIX: SUPPORTING DETAILS (1)
  • 12.1 Clinical Laboratory Tests (1)
  • 12.2 Country/Region-Specific Differences (3)
  • 12.3 Prior Protocol Amendment(s) (9)
• 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS (1)
• 14 APPENDIX: REFERENCES (1)
• Amendment Details (18)
• Title Page (39)

Draft, not normative. A derived rendering of the ICH M11 Technical Specification, Template, code lists and OID Listing (© ICH, used under the ICH Legal Mentions) and of the ICH M11 Terminology published by NCI EVS (CC BY 4.0). Not an ICH, CDISC or HL7 artifact, and not endorsed or sponsored by ICH.