C217360Level 5

ICH M11 Protocol Section Title

**Semantic type:** Qualitative Concept

**Definition:** An identifying designation for a section within the ICH M11 protocol template document.

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C218514ICH M11 Protocol Section 1 PROTOCOL SUMMARY

C218515ICH M11 Protocol Section 1.1 Protocol Synopsis

C218516ICH M11 Protocol Section 1.1.1 Primary and Secondary Objectives and Estimands

C218517ICH M11 Protocol Section 1.1.2 Overall Design

C218518ICH M11 Protocol Section 1.2 Trial Schema

C218519ICH M11 Protocol Section 1.3 Schedule of Activities

C218520ICH M11 Protocol Section 2 INTRODUCTION

C218521ICH M11 Protocol Section 2.1 Purpose of Trial

C218522ICH M11 Protocol Section 2.2 Assessment of Risks and Benefits

C218523ICH M11 Protocol Section 2.2.1 Risk Summary and Mitigation Strategy

C218524ICH M11 Protocol Section 2.2.2 Benefit Summary

C218525ICH M11 Protocol Section 2.2.3 Overall Risk-Benefit Assessment

C218526ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS

C218527ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s)

C218528ICH M11 Protocol Section 3.1.1 Primary Objective

C218529ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s)

C218530ICH M11 Protocol Section 3.2.1 Secondary Objective

C218531ICH M11 Protocol Section 3.3 Exploratory Objective(s)

C218532ICH M11 Protocol Section 3.3.1 Exploratory Objective

C218533ICH M11 Protocol Section 4 TRIAL DESIGN

C218534ICH M11 Protocol Section 4.1 Description of Trial Design

C218535ICH M11 Protocol Section 4.1.1 Stakeholder Input into Design

C218536ICH M11 Protocol Section 4.2 Rationale for Trial Design

C218537ICH M11 Protocol Section 4.2.1 Rationale for Estimand(s)

C218538ICH M11 Protocol Section 4.2.2 Rationale for Intervention Model

C218539ICH M11 Protocol Section 4.2.3 Rationale for Control Type

C218540ICH M11 Protocol Section 4.2.4 Rationale for Trial Duration

C218541ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial Design

C218542ICH M11 Protocol Section 4.2.6 Rationale for Interim Analysis

C218543ICH M11 Protocol Section 4.2.7 Rationale for Other Trial Design Aspects

C218544ICH M11 Protocol Section 4.3 Trial Stopping Rules

C218545ICH M11 Protocol Section 4.4 Start of Trial and End of Trial

C218546ICH M11 Protocol Section 4.5 Access to Trial Intervention After End of Trial

C218547ICH M11 Protocol Section 5 TRIAL POPULATION

C218548ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale

C218549ICH M11 Protocol Section 5.2 Inclusion Criteria

C218550ICH M11 Protocol Section 5.3 Exclusion Criteria

C218551ICH M11 Protocol Section 5.4 Contraception

C218552ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential

C218553ICH M11 Protocol Section 5.4.2 Contraception Requirements

C218554ICH M11 Protocol Section 5.5 Lifestyle Restrictions

C218555ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions

C218556ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions

C218557ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions

C218558ICH M11 Protocol Section 5.5.4 Other Activity Restrictions

C218559ICH M11 Protocol Section 5.6 Screen Failure and Rescreening

C218560ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY

C218561ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention

C218562ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen

C218563ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration

C218564ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification

C218565ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose

C218566ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention

C218567ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention

C218568ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention

C218569ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention

C218570ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding

C218571ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention

C218572ICH M11 Protocol Section 6.7.2 Randomisation

C218573ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding

C218574ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site

C218575ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence

C218576ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention

C218577ICH M11 Protocol Section 6.9.1 Background Trial Intervention

C218578ICH M11 Protocol Section 6.9.2 Rescue Therapy

C218579ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention

C218580ICH M11 Protocol Section 6.10 Concomitant Therapy

C218581ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy

C218582ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy

C218583ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL

C218584ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants

C218585ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention

C218586ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention

C218587ICH M11 Protocol Section 7.1.3 Rechallenge

C218588ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial

C218589ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up

C218590ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES

C218591ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations

C218592ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures

C218593ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures

C218594ICH M11 Protocol Section 8.4 Safety Assessments and Procedures

C218595ICH M11 Protocol Section 8.4.1 Physical Examination

C218596ICH M11 Protocol Section 8.4.2 Vital Signs

C218597ICH M11 Protocol Section 8.4.3 Electrocardiograms

C218598ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments

C218599ICH M11 Protocol Section 8.4.5 Pregnancy Testing

C218600ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring

C218601ICH M11 Protocol Section 8.5 Pharmacokinetics

C218602ICH M11 Protocol Section 8.6 Biomarkers

C218603ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics

C218604ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers

C218605ICH M11 Protocol Section 8.6.3 Other Biomarkers

C218606ICH M11 Protocol Section 8.7 Immunogenicity Assessments

C218607ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics

C218608ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS

C218609ICH M11 Protocol Section 9.1 Definitions

C218610ICH M11 Protocol Section 9.1.1 Definitions of Adverse Events

C218611ICH M11 Protocol Section 9.1.2 Definitions of Serious Adverse Events

C218612ICH M11 Protocol Section 9.1.3 Definitions of Product Complaints

C218613ICH M11 Protocol Section 9.1.3.1 Definitions of Medical Device Product Complaints

C218614ICH M11 Protocol Section 9.2 Timing and Procedures for Collection and Reporting

C218615ICH M11 Protocol Section 9.2.1 Timing

C218616ICH M11 Protocol Section 9.2.2 Collection Procedures

C218617ICH M11 Protocol Section 9.2.3 Reporting

C218618ICH M11 Protocol Section 9.2.3.1 Regulatory Reporting Requirements

C218619ICH M11 Protocol Section 9.2.4 Adverse Events of Special Interest

C218620ICH M11 Protocol Section 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs

C218621ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information

C218622ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the Trial

C218623ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the Trial

C218624ICH M11 Protocol Section 9.4 Special Safety Situations

C218625ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS

C218626ICH M11 Protocol Section 10.1 General Considerations

C218627ICH M11 Protocol Section 10.2 Analysis Sets

C218628ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables

C218629ICH M11 Protocol Section 10.4 Analyses Associated with the Primary Objective(s)

C218630ICH M11 Protocol Section 10.4.1 Primary Objective

C218631ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method

C218632ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)

C218633ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)

C218634ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis

C218635ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis

C218636ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)

C218637ICH M11 Protocol Section 10.5.1 Secondary Objective

C218638ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method

C218639ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)

C218640ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)

C218641ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis

C218642ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis

C218643ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)

C218644ICH M11 Protocol Section 10.7 Safety Analyses

C218645ICH M11 Protocol Section 10.8 Other Analyses

C218646ICH M11 Protocol Section 10.9 Interim Analyses

C218647ICH M11 Protocol Section 10.10 Multiplicity Adjustments

C218648ICH M11 Protocol Section 10.11 Sample Size Determination

C218649ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS

C218650ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations

C218651ICH M11 Protocol Section 11.2 Trial Oversight

C218652ICH M11 Protocol Section 11.2.1 Investigator Responsibilities

C218653ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities

C218654ICH M11 Protocol Section 11.3 Informed Consent Process

C218655ICH M11 Protocol Section 11.3.1 Informed Consent for Rescreening

C218656ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research

C218657ICH M11 Protocol Section 11.4 Committees

C218658ICH M11 Protocol Section 11.5 Insurance and Indemnity

C218659ICH M11 Protocol Section 11.6 Risk-Based Quality Management

C218660ICH M11 Protocol Section 11.7 Data Governance

C218661ICH M11 Protocol Section 11.8 Data Protection

C218662ICH M11 Protocol Section 11.9 Source Records

C218663ICH M11 Protocol Section 11.10 Protocol Deviations

C218664ICH M11 Protocol Section 11.11 Early Site Closure

C218665ICH M11 Protocol Section 11.12 Data Dissemination

C218666ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS

C218667ICH M11 Protocol Section 12.1 Clinical Laboratory Tests

C218668ICH M11 Protocol Section 12.2 Country/Region-Specific Differences

C218669ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s)

C218670ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS

C218671ICH M11 Protocol Section 14 APPENDIX: REFERENCES

C222769ICH M11 Protocol Section Title Page

C222770ICH M11 Protocol Section Amendment Details

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