ICH M11 Template

The headings and fields of the ICH M11 Template (Step 4, 19 November 2025), in Template order: 159 headings on their sections, 281 fields, 271 of them linked to the element they realise. Instructional and universal text is not carried; the page links point into the PDF. Optional = printed in blue, conditional = in {braces} (Template section 0.3). How fields were linked: D5 report.

Title Page

Amendment Details

p. 13 · heading is Amendment Details

1 PROTOCOL SUMMARY

p. 22

1.1 Protocol Synopsis

p. 22

1.1.1 Primary and Secondary Objectives and Estimands

p. 22 · heading is Primary and Secondary Objectives and Estimands

1.1.2 Overall Design

p. 22

1.2 Trial Schema

p. 25 · heading is Trial Schema

1.3 Schedule of Activities

p. 25 · heading is Schedule of Activities

2 INTRODUCTION

p. 26

2.1 Purpose of Trial

p. 26 · heading is Purpose of Trial

2.2 Assessment of Risks and Benefits

p. 26

2.2.1 Risk Summary and Mitigation Strategy

p. 26 · optional

2.2.2 Benefit Summary

p. 26 · optional · heading is Benefit Summary

2.2.3 Overall Risk-Benefit Assessment

p. 27 · optional · heading is Overall Risk-Benefit Assessment

3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS

p. 27

3.1 Primary Objective(s) and Associated Estimand(s)

p. 27

3.1.1 Primary Objective <#>

p. 28

3.2 Secondary Objective(s) and Associated Estimand(s)

p. 28

3.2.1 {Secondary Objective <#>}

p. 29 · conditional

3.3 Exploratory Objective(s)

p. 29

3.3.1 {Exploratory Objective <#>}

p. 29 · conditional

4 TRIAL DESIGN

p. 30

4.1 Description of Trial Design

p. 30

4.1.1 Stakeholder Input into Design

p. 31 · optional · heading is Stakeholder Input into Design

4.2 Rationale for Trial Design

p. 31

4.2.1 Rationale for Estimand(s)

p. 31 · optional · heading is Rationale for Estimand(s)

4.2.2 Rationale for Intervention Model

p. 31 · optional · heading is Rationale for Intervention Model

4.2.3 Rationale for Control Type

p. 31 · optional · heading is Rationale for Control Type

4.2.4 Rationale for Trial Duration

p. 32 · optional · heading is Rationale for Trial Duration

4.2.5 Rationale for Adaptive or Novel Trial Design

p. 32 · optional · heading is Rationale for Adaptive or Novel Trial Design

4.2.6 Rationale for Interim Analysis

p. 32 · optional · heading is Rationale for Interim Analysis

4.2.7 Rationale for Other Trial Design Aspects

p. 32 · optional · heading is Rationale for Other Trial Design Aspects

4.3 Trial Stopping Rules

p. 32 · heading is Trial Stopping Rules

4.4 Start of Trial and End of Trial

p. 32

4.5 Access to Trial Intervention After End of Trial

p. 33 · heading is Access to Trial Intervention After End of Trial

5 TRIAL POPULATION

p. 33

5.1 Description of Trial Population and Rationale

p. 33 · heading is Description of Trial Population and Rationale

5.2 Inclusion Criteria

p. 34

5.3 Exclusion Criteria

p. 34

5.4 Contraception

p. 34

5.4.1 Definitions Related to Childbearing Potential

p. 34 · heading is Definitions Related to Childbearing Potential

5.4.2 Contraception Requirements

p. 34 · heading is Contraception Requirements

5.5 Lifestyle Restrictions

p. 35 · heading is Lifestyle Restrictions

5.5.1 Meals and Dietary Restrictions

p. 35 · optional · heading is Meals and Dietary Restrictions

5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions

p. 35 · optional · heading is Caffeine, Alcohol, Tobacco, and Other Restrictions

5.5.3 Physical Activity Restrictions

p. 35 · optional · heading is Physical Activity Restrictions

5.5.4 Other Activity Restrictions

p. 35 · optional · heading is Other Activity Restrictions

5.6 Screen Failure and Rescreening

p. 35

6 TRIAL INTERVENTION AND CONCOMITANT THERAPY

p. 35

6.1 Description of Investigational Trial Intervention

p. 38 · heading is Description of Investigational Trial Intervention

6.2 Rationale for Investigational Trial Intervention Dose and Regimen

p. 38 · heading is Rationale for Investigational Trial Intervention Dose and Regimen

6.3 Investigational Trial Intervention Administration

p. 38 · heading is Investigational Trial Intervention Administration

6.4 Investigational Trial Intervention Dose Modification

p. 38 · heading is Investigational Trial Intervention Dose Modification

6.5 Management of Investigational Trial Intervention Overdose

p. 39 · heading is Management of Investigational Trial Intervention Overdose

6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention

p. 39

6.6.1 Preparation of Investigational Trial Intervention

p. 39 · heading is Preparation of Investigational Trial Intervention

6.6.2 Storage and Handling of Investigational Trial Intervention

p. 39 · heading is Storage and Handling of Investigational Trial Intervention

6.6.3 Accountability of Investigational Trial Intervention

p. 40 · heading is Accountability of Investigational Trial Intervention

6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding

p. 40

6.7.1 Participant Assignment to Investigational Trial Intervention

p. 40 · heading is Participant Assignment to Investigational Trial Intervention

6.7.2 {Randomisation}

p. 40 · conditional · heading is Randomisation

6.7.3 {Measures to Maintain Blinding}

p. 40 · conditional · heading is Measures to Maintain Blinding

6.7.4 {Emergency Unblinding at the Site}

p. 41 · conditional · heading is Emergency Unblinding at the Site

6.8 Investigational Trial Intervention Adherence

p. 41 · heading is Investigational Trial Intervention Adherence

6.9 Description of Noninvestigational Trial Intervention

p. 41 · heading is Description of Noninvestigational Trial Intervention

6.9.1 {Background Trial Intervention}

p. 41 · conditional · heading is Background Trial Intervention

6.9.2 {Rescue Therapy}

p. 41 · conditional · heading is Rescue Therapy

6.9.3 {Other Noninvestigational Trial Intervention}

p. 42 · conditional · heading is Other Noninvestigational Trial Intervention

6.10 Concomitant Therapy

p. 42 · heading is Concomitant Therapy

6.10.1 {Prohibited Concomitant Therapy}

p. 42 · conditional · heading is Prohibited Concomitant Therapy

6.10.2 {Permitted Concomitant Therapy}

p. 42 · conditional · heading is Permitted Concomitant Therapy

7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL

p. 42

7.1 Discontinuation of Trial Intervention for Individual Participants

p. 42

7.1.1 Permanent Discontinuation of Trial Intervention

p. 42 · heading is Permanent Discontinuation of Trial Intervention

7.1.2 Temporary Discontinuation of Trial Intervention

p. 43 · heading is Temporary Discontinuation of Trial Intervention

7.1.3 Rechallenge

p. 43 · heading is Rechallenge

7.2 Participant Discontinuation or Withdrawal from the Trial

p. 43

7.3 Management of Loss to Follow-Up

p. 44 · heading is Management of Loss to Follow-Up

8 TRIAL ASSESSMENTS AND PROCEDURES

p. 45

8.1 Trial Assessments and Procedures Considerations

p. 45 · heading is Trial Assessments and Procedures Considerations

8.2 Screening/Baseline Assessments and Procedures

p. 45

8.3 Efficacy Assessments and Procedures

p. 46 · heading is Efficacy Assessments and Procedures

8.4 Safety Assessments and Procedures

p. 46 · heading is Safety Assessments and Procedures

8.4.1 {Physical Examination}

p. 46 · conditional · heading is Physical Examination

8.4.2 {Vital Signs}

p. 46 · conditional · heading is Vital Signs

8.4.3 {Electrocardiograms}

p. 46 · conditional · heading is Electrocardiograms

8.4.4 {Clinical Laboratory Assessments}

p. 46 · conditional · heading is Clinical Laboratory Assessments

8.4.5 {Pregnancy Testing}

p. 47 · conditional · heading is Pregnancy Testing

8.4.6 {Suicidal Ideation and Behaviour Risk Monitoring}

p. 47 · conditional · heading is Suicidal Ideation and Behaviour Risk Monitoring

8.5 Pharmacokinetics

p. 47 · heading is Pharmacokinetics

8.6 Biomarkers

p. 47

8.6.1 Genetics, Genomics, Pharmacogenetics, and Pharmacogenomics

p. 47 · heading is Genetics, Genomics, Pharmacogenetics and Pharmacogenomics

8.6.2 Pharmacodynamic Biomarkers

p. 48 · heading is Pharmacodynamic Biomarkers

8.6.3 {Other Biomarkers}

p. 48 · conditional · heading is Other Biomarkers

8.7 Immunogenicity Assessments

p. 48 · heading is Immunogenicity Assessments

8.8 Medical Resource Utilisation and Health Economics

p. 49 · heading is Medical Resource Utilisation and Health Economics

9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS

p. 50

9.1 Definitions

p. 50

9.1.1 Definitions of Adverse Events

p. 50 · heading is Definitions of Adverse Events

9.1.2 Definitions of Serious Adverse Events

p. 50 · heading is Definitions of Serious Adverse Events

9.1.3 Definitions of Product Complaints

p. 50 · heading is Definitions of Product Complaints

9.1.3.1 {Definitions of Medical Device Product Complaints}

p. 50 · conditional · heading is Definitions of Medical Device Product Complaints

9.2 Timing and Procedures for Collection and Reporting

p. 50

9.2.1 Timing

p. 51

9.2.2 Collection Procedures

p. 51

9.2.3 Reporting

p. 52 · heading is Reporting

9.2.3.1 Regulatory Reporting Requirements

p. 52 · heading is Regulatory Reporting Requirements

9.2.4 Adverse Events of Special Interest

p. 52

9.2.5 Disease-Related Events or Outcomes Not Qualifying as AEs or SAEs

p. 53 · heading is Disease-related Events or Outcomes Not Qualifying as AEs or SAEs

9.3 Pregnancy and Postpartum Information

p. 53

9.3.1 {Participants Who Become Pregnant During the Trial}

p. 53 · conditional · heading is Participants Who Become Pregnant During the Trial

9.3.2 {Participants Whose Partners Become Pregnant During the Trial}

p. 54 · conditional · heading is Participants Whose Partners Become Pregnant During the Trial

9.4 Special Safety Situations

p. 54 · heading is Special Safety Situations

10 STATISTICAL CONSIDERATIONS

p. 54

10.1 General Considerations

p. 55 · heading is General Considerations

10.2 Analysis Sets

p. 55 · heading is Analysis Sets

10.3 Analyses of Demographics and Other Baseline Variables

p. 55 · heading is Analyses of Demographics and Other Baseline Variables

10.4 Analyses Associated with the Primary Objective(s)

p. 55

10.4.1 Primary Objective <#>

p. 55

10.4.1.1 Statistical Analysis Method

p. 55 · heading is Statistical Analysis Method

10.4.1.2 Handling of Data in Relation to Primary Estimand(s)

p. 56 · heading is Handling of Data in Relation to Primary Estimand(s)

10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)

p. 56 · heading is Handling of Missing Data in Relation to Primary Estimand(s)

10.4.1.4 {Sensitivity Analysis}

p. 56 · conditional · heading is Sensitivity Analysis

10.4.1.5 {Supplementary Analysis}

p. 56 · conditional · heading is Supplementary Analysis

10.5 Analyses Associated with the Secondary Objective(s)

p. 56

10.5.1 {Secondary Objective <#>}

p. 57 · conditional

10.5.1.1 {Statistical Analysis Method}

p. 57 · conditional · heading is Statistical Analysis Method

10.5.1.2 {Handling of Data in Relation to Secondary Estimand(s)}

p. 57 · conditional · heading is Handling of Data in Relation to Secondary Estimand(s)

10.5.1.3 {Handling of Missing Data in Relation to Secondary Estimand(s)}

p. 57 · conditional · heading is Handling of Missing Data in Relation to Secondary Estimand(s)

10.5.1.4 {Sensitivity Analysis}

p. 57 · conditional · heading is Sensitivity Analysis

10.5.1.5 {Supplementary Analysis}

p. 57 · conditional · heading is Supplementary Analysis

10.6 Analyses Associated with the Exploratory Objective(s)

p. 57 · heading is Analyses Associated with the Exploratory Objective(s)

10.7 Safety Analyses

p. 57 · heading is Safety Analyses

10.8 Other Analyses

p. 57 · heading is Other Analyses

10.9 Interim Analyses

p. 58 · heading is Interim Analyses

10.10 Multiplicity Adjustments

p. 58 · heading is Multiplicity Adjustments

10.11 Sample Size Determination

p. 59 · heading is Sample Size Determination

11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS

p. 59

11.1 Regulatory and Ethical Considerations

p. 59 · heading is Regulatory and Ethical Considerations

11.2 Trial Oversight

p. 60 · heading is Trial Oversight

11.2.1 Investigator Responsibilities

p. 60 · optional · heading is Investigator Responsibilities

11.2.2 Sponsor Responsibilities

p. 60 · optional · heading is Sponsor Responsibilities

11.3 Informed Consent Process

p. 60

11.3.1 {Informed Consent for Rescreening}

p. 61 · conditional · heading is Informed Consent for Rescreening

11.3.2 {Informed Consent for Use of Remaining Samples in Exploratory Research}

p. 61 · conditional · heading is Informed Consent for Use of Remaining Samples in Exploratory Research

11.4 Committees

p. 61 · heading is Committees

11.5 Insurance and Indemnity

p. 61 · heading is Insurance and Indemnity

11.6 Risk-Based Quality Management

p. 61 · heading is Risk-Based Quality Management

11.7 Data Governance

p. 61 · heading is Data Governance

11.8 Data Protection

p. 62 · heading is Data Protection

11.9 Source Records

p. 62

11.10 Protocol Deviations

p. 62 · heading is Protocol Deviations

11.11 Early Site Closure

p. 62

11.12 Data Dissemination

p. 62 · heading is Data Dissemination

12 APPENDIX: SUPPORTING DETAILS

p. 64

12.1 Clinical Laboratory Tests

p. 64 · heading is Clinical Laboratory Tests

12.2 Country/Region-Specific Differences

p. 64

12.3 Prior Protocol Amendment(s)

p. 64 · heading is Prior Protocol Amendment(s)

13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS

p. 67

14 APPENDIX: REFERENCES

p. 67

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.