ShortName = Protocol Section Name and Number Response Terminology LongName = Protocol Section Name and Number Response Terminology Version = 1.0 CanonicalUri = 2.16.840.1.113883.3.989.2.3.1.13 CanonicalVersionUri = 2.16.840.1.113883.3.989.2.3.1.13.1 Agency
ShortName = M11 LongName = Clinical Trial protocols Identifier = C217272
| code Id="code" (required) Type="string" |
english-label Id="en" (optional) Type="string" Lang="en" |
M11 Definition Id="en_def" (optional) Type="string" Lang="en" |
current flag Id="cf" (optional) Type="string" Lang="en" |
|---|---|---|---|
| C218514 | 1 PROTOCOL SUMMARY | Section 1 of the ICH M11 Protocol standard, PROTOCOL SUMMARY. | y |
| C218515 | 1.1 Protocol Synopsis | Section 1.1 of the ICH M11 Protocol standard, Protocol Synopsis. | y |
| C218516 | 1.1.1 Primary and Secondary Objectives and Estimands | Section 1.1.1 of the ICH M11 Protocol standard, Primary and Secondary Objectives and Estimands. | y |
| C218517 | 1.1.2 Overall Design | Section 1.1.2 of the ICH M11 Protocol standard, Overall Design. | y |
| C218518 | 1.2 Trial Schema | Section 1.2 of the ICH M11 Protocol standard, Trial Schema. | y |
| C218519 | 1.3 Schedule of Activities | Section 1.3 of the ICH M11 Protocol standard, Schedule of Activities. | y |
| C218625 | 10 STATISTICAL CONSIDERATIONS | Section 10 of the ICH M11 Protocol standard, STATISTICAL CONSIDERATIONS. | y |
| C218626 | 10.1 General Considerations | Section 10.1 of the ICH M11 Protocol standard, General Considerations. | y |
| C218647 | 10.10 Multiplicity Adjustments | Section 10.10 of the ICH M11 Protocol standard, Multiplicity Adjustments. | y |
| C218648 | 10.11 Sample Size Determination | Section 10.11 of the ICH M11 Protocol standard, Sample Size Determination. | y |
| C218627 | 10.2 Analysis Sets | Section 10.2 of the ICH M11 Protocol standard, Analysis Sets. | y |
| C218628 | 10.3 Analyses of Demographics and Other Baseline Variables | Section 10.3 of the ICH M11 Protocol standard, Analyses of Demographics and Other Baseline Variables. | y |
| C218629 | 10.4 Analyses Associated with the Primary Objective(s) | Section 10.4 of the ICH M11 Protocol standard, Analyses Associated with the Primary Objective(s). | y |
| C218630 | 10.4.1 Primary Objective | Section 10.4.1 of the ICH M11 Protocol standard, Primary Objective. | y |
| C218631 | 10.4.1.1 Statistical Analysis Method | Section 10.4.1.1 of the ICH M11 Protocol standard, Statistical Analysis Method. | y |
| C218632 | 10.4.1.2 Handling of Data in Relation to Primary Estimand(s) | Section 10.4.1.2 of the ICH M11 Protocol standard, Handling of Data in Relation to Primary Estimand(s). | y |
| C218633 | 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s) | Section 10.4.1.3 of the ICH M11 Protocol standard, Handling of Missing Data in Relation to Primary Estimand(s) | y |
| C218634 | 10.4.1.4 Sensitivity Analysis | Section 10.4.1.4 of the ICH M11 Protocol standard, Sensitivity Analysis. | y |
| C218635 | 10.4.1.5 Supplementary Analysis | Section 10.4.1.5 of the ICH M11 Protocol standard, Supplementary Analysis. | y |
| C218636 | 10.5 Analyses Associated with the Secondary Objective(s) | Section 10.5 of the ICH M11 Protocol standard, Analyses Associated with the Secondary Objective(s). | y |
| C218637 | 10.5.1 Secondary Objective | Section 10.5.1 of the ICH M11 Protocol standard, Secondary Objective. | y |
| C218638 | 10.5.1.1 Statistical Analysis Method | Section 10.5.1.1 of the ICH M11 Protocol standard, Statistical Analysis Method. | y |
| C218639 | 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s) | Section 10.5.1.2 of the ICH M11 Protocol standard, Handling of Data in Relation to Secondary Estimand(s). | y |
| C218640 | 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s) | Section 10.5.1.3 of the ICH M11 Protocol standard, Handling of Missing Data in Relation to Secondary Estimand(s). | y |
| C218641 | 10.5.1.4 Sensitivity Analysis | Section 10.5.1.4 of the ICH M11 Protocol standard, Sensitivity Analysis. | y |
| C218642 | 10.5.1.5 Supplementary Analysis | Section 10.5.1.5 of the ICH M11 Protocol standard, Supplementary Analysis. | y |
| C218643 | 10.6 Analyses Associated with the Exploratory Objective(s) | Section 10.6 of the ICH M11 Protocol standard, Analyses Associated with the Exploratory Objective(s). | y |
| C218644 | 10.7 Safety Analyses | Section 10.7 of the ICH M11 Protocol standard, Safety Analyses. | y |
| C218645 | 10.8 Other Analyses | Section 10.8 of the ICH M11 Protocol standard, Other Analyses. | y |
| C218646 | 10.9 Interim Analyses | Section 10.9 of the ICH M11 Protocol standard, Interim Analyses. | y |
| C218649 | 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS | Section 11 of the ICH M11 Protocol standard, TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS. | y |
| C218650 | 11.1 Regulatory and Ethical Considerations | Section 11.1 of the ICH M11 Protocol standard, Regulatory and Ethical Considerations. | y |
| C218663 | 11.10 Protocol Deviations | Section 11.10 of the ICH M11 Protocol standard, Protocol Deviations. | y |
| C218664 | 11.11 Early Site Closure | Section 11.11 of the ICH M11 Protocol standard, Early Site Closure. | y |
| C218665 | 11.12 Data Dissemination | Section 11.12 of the ICH M11 Protocol standard, Data Dissemination. | y |
| C218651 | 11.2 Trial Oversight | Section 11.2 of the ICH M11 Protocol standard, Trial Oversight. | y |
| C218652 | 11.2.1 Investigator Responsibilities | Section 11.2.1 of the ICH M11 Protocol standard, Investigator Responsibilities. | y |
| C218653 | 11.2.2 Sponsor Responsibilities | Section 11.2.2 of the ICH M11 Protocol standard, Sponsor Responsibilities. | y |
| C218654 | 11.3 Informed Consent Process | Section 11.3 of the ICH M11 Protocol standard, Informed Consent Process. | y |
| C218655 | 11.3.1 Informed Consent for Rescreening | Section 11.3.1 of the ICH M11 Protocol standard, Informed Consent for Rescreening. | y |
| C218656 | 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research | Section 11.3.2 of the ICH M11 Protocol standard, Informed Consent for Use of Remaining Samples in Exploratory Research. | y |
| C218657 | 11.4 Committees | Section 11.4 of the ICH M11 Protocol standard, Committees. | y |
| C218658 | 11.5 Insurance and Indemnity | Section 11.5 of the ICH M11 Protocol standard, Insurance and Indemnity. | y |
| C218659 | 11.6 Risk-Based Quality Management | Section 11.6 of the ICH M11 Protocol standard, Risk-Based Quality Management. | y |
| C218660 | 11.7 Data Governance | Section 11.7 of the ICH M11 Protocol standard, Data Governance. | y |
| C218661 | 11.8 Data Protection | Section 11.8 of the ICH M11 Protocol standard, Data Protection. | y |
| C218662 | 11.9 Source Records | Section 11.9 of the ICH M11 Protocol standard, Source Records. | y |
| C218666 | 12 APPENDIX: SUPPORTING DETAILS | Section 12 of the ICH M11 Protocol standard, APPENDIX: SUPPORTING DETAILS. | y |
| C218667 | 12.1 Clinical Laboratory Tests | Section 12.1 of the ICH M11 Protocol standard, Clinical Laboratory Tests. | y |
| C218668 | 12.2 Country/Region-Specific Differences | Section 12.2 of the ICH M11 Protocol standard, Country/Region-Specific Differences. | y |
| C218669 | 12.3 Prior Protocol Amendment(s) | Section 12.3 of the ICH M11 Protocol standard, Prior Protocol Amendment(s). | y |
| C218670 | 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS | Section 13 of the ICH M11 Protocol standard, APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS. | y |
| C218671 | 14 APPENDIX: REFERENCES | Section 14 of the ICH M11 Protocol standard, APPENDIX: REFERENCES. | y |
| C218520 | 2 INTRODUCTION | Section 2 of the ICH M11 Protocol standard, INTRODUCTION. | y |
| C218521 | 2.1 Purpose of Trial | Section 2.1 of the ICH M11 Protocol standard, Purpose of Trial. | y |
| C218522 | 2.2 Assessment of Risks and Benefits | Section 2.2 of the ICH M11 Protocol standard, Assessment of Risks and Benefits. | y |
| C218523 | 2.2.1 Risk Summary and Mitigation Strategy | Section 2.2.2 of the ICH M11 Protocol standard, Risk Summary and Mitigation Strategy. | y |
| C218524 | 2.2.2 Benefit Summary | Section 2.2.1 of the ICH M11 Protocol standard, Benefit Summary. | y |
| C218525 | 2.2.3 Overall Risk-Benefit Assessment | Section 2.2.3 of the ICH M11 Protocol standard, Overall Risk-Benefit Assessment. | y |
| C218526 | 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS | Section 3 of the ICH M11 Protocol standard, TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS. | y |
| C218527 | 3.1 Primary Objective(s) and Associated Estimand(s) | Section 3.1 of the ICH M11 Protocol standard, Primary Objective(s) and Associated Estimand(s). | y |
| C218528 | 3.1.1 Primary Objective | Section 3.1.1 of the ICH M11 Protocol standard, Primary Objective. | y |
| C218529 | 3.2 Secondary Objective(s) and Associated Estimand(s) | Section 3.2 of the ICH M11 Protocol standard, Secondary Objective(s) and Associated Estimand(s). | y |
| C218530 | 3.2.1 Secondary Objective | Section 3.2.1 of the ICH M11 Protocol standard, Secondary Objective. | y |
| C218531 | 3.3 Exploratory Objective(s) | Section 3.3 of the ICH M11 Protocol standard, Exploratory Objective(s). | y |
| C218532 | 3.3.1 Exploratory Objective | Section 3.3.1 of the ICH M11 Protocol standard, Exploratory Objective. | y |
| C218533 | 4 TRIAL DESIGN | Section 4 of the ICH M11 Protocol standard, TRIAL DESIGN. | y |
| C218534 | 4.1 Description of Trial Design | Section 4.1 of the ICH M11 Protocol standard, Description of Trial Design. | y |
| C218535 | 4.1.1 Stakeholder Input into Design | Section 4.1.1 of the ICH M11 Protocol standard, Stakeholder Input into Design. | y |
| C218536 | 4.2 Rationale for Trial Design | Section 4.2 of the ICH M11 Protocol standard, Rationale for Trial Design. | y |
| C218537 | 4.2.1 Rationale for Estimand(s) | Section 4.2.1 of the ICH M11 Protocol standard, Rationale for Estimand(s). | y |
| C218538 | 4.2.2 Rationale for Intervention Model | Section 4.2.2 of the ICH M11 Protocol standard, Rationale for Intervention Model. | y |
| C218539 | 4.2.3 Rationale for Control Type | Section 4.2.3 of the ICH M11 Protocol standard, Rationale for Control Type. | y |
| C218540 | 4.2.4 Rationale for Trial Duration | Section 4.2.4 of the ICH M11 Protocol standard, Rationale for Trial Duration. | y |
| C218541 | 4.2.5 Rationale for Adaptive or Novel Trial Design | Section 4.2.5 of the ICH M11 Protocol standard, Rationale for Adaptive or Novel Trial Design. | y |
| C218542 | 4.2.6 Rationale for Interim Analysis | Section 4.2.6 of the ICH M11 Protocol standard, Rationale for Interim Analysis. | y |
| C218543 | 4.2.7 Rationale for Other Trial Design Aspects | Section 4.2.7 of the ICH M11 Protocol standard, Rationale for Other Trial Design Aspects. | y |
| C218544 | 4.3 Trial Stopping Rules | Section 4.3 of the ICH M11 Protocol standard, Trial Stopping Rules. | y |
| C218545 | 4.4 Start of Trial and End of Trial | Section 4.4 of the ICH M11 Protocol standard, Start of Trial and End of Trial. | y |
| C218546 | 4.5 Access to Trial Intervention After End of Trial | Section 4.5 of the ICH M11 Protocol standard, Access to Trial Intervention After End of Trial. | y |
| C218547 | 5 TRIAL POPULATION | Section 5 of the ICH M11 Protocol standard, TRIAL POPULATION. | y |
| C218548 | 5.1 Description of Trial Population and Rationale | Section 5.1 of the ICH M11 Protocol standard, Description of Trial Population and Rationale. | y |
| C218549 | 5.2 Inclusion Criteria | Section 5.2 of the ICH M11 Protocol standard, Inclusion Criteria. | y |
| C218550 | 5.3 Exclusion Criteria | Section 5.3 of the ICH M11 Protocol standard, Exclusion Criteria. | y |
| C218551 | 5.4 Contraception | Section 5.4 of the ICH M11 Protocol standard, Contraception. | y |
| C218552 | 5.4.1 Definitions Related to Childbearing Potential | Section 5.4.1 of the ICH M11 Protocol standard, Definitions Related to Childbearing Potential. | y |
| C218553 | 5.4.2 Contraception Requirements | Section 5.4.2 of the ICH M11 Protocol standard, Contraception Requirements. | y |
| C218554 | 5.5 Lifestyle Restrictions | Section 5.5 of the ICH M11 Protocol standard, Lifestyle Restrictions. | y |
| C218555 | 5.5.1 Meals and Dietary Restrictions | Section 5.5.1 of the ICH M11 Protocol standard, Meals and Dietary Restrictions. | y |
| C218556 | 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions | Section 5.5.2 of the ICH M11 Protocol standard, Caffeine, Alcohol, Tobacco, and Other Restrictions. | y |
| C218557 | 5.5.3 Physical Activity Restrictions | Section 5.5.3 of the ICH M11 Protocol standard, Physical Activity Restrictions. | y |
| C218558 | 5.5.4 Other Activity Restrictions | Section 5.5.4 of the ICH M11 Protocol standard, Other Activity Restrictions. | y |
| C218559 | 5.6 Screen Failure and Rescreening | Section 5.6 of the ICH M11 Protocol standard, Screen Failure and Rescreening. | y |
| C218560 | 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY | Section 6 of the ICH M11 Protocol standard, TRIAL INTERVENTION AND CONCOMITANT THERAPY. | y |
| C218561 | 6.1 Description of Investigational Trial Intervention | Section 6.1 of the ICH M11 Protocol standard, Description of Investigational Trial Intervention. | y |
| C218580 | 6.10 Concomitant Therapy | Section 6.10 of the ICH M10 Protocol standard, Concomitant Therapy. | y |
| C218581 | 6.10.1 Prohibited Concomitant Therapy | Section 6.10.1 of the ICH M10 Protocol standard, Prohibited Concomitant Therapy. | y |
| C218582 | 6.10.2 Permitted Concomitant Therapy | Section 6.10.2 of the ICH M10 Protocol standard, Permitted Concomitant Therapy. | y |
| C218562 | 6.2 Rationale for Investigational Trial Intervention Dose and Regimen | Section 6.2 of the ICH M11 Protocol standard, Rationale for Investigational Trial Intervention Dose and Regimen. | y |
| C218563 | 6.3 Investigational Trial Intervention Administration | Section 6.3 of the ICH M11 Protocol standard, Investigational Trial Intervention Administration. | y |
| C218564 | 6.4 Investigational Trial Intervention Dose Modification | Section 6.4 of the ICH M11 Protocol standard, Investigational Trial Intervention Dose Modification. | y |
| C218565 | 6.5 Management of Investigational Trial Intervention Overdose | Section 6.5 of the ICH M11 Protocol standard, Management of Investigational Trial Intervention Overdose. | y |
| C218566 | 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention | Section 6.6 of the ICH M11 Protocol standard, Preparation, Storage, Handling and Accountability of Investigational Trial Intervention. | y |
| C218567 | 6.6.1 Preparation of Investigational Trial Intervention | Section 6.6.1 of the ICH M11 Protocol standard, Preparation of Investigational Trial Intervention. | y |
| C218568 | 6.6.2 Storage and Handling of Investigational Trial Intervention | Section 6.6.2 of the ICH M11 Protocol standard, Storage and Handling of Investigational Trial Intervention. | y |
| C218569 | 6.6.3 Accountability of Investigational Trial Intervention | Section 6.6.3 of the ICH M11 Protocol standard, Accountability of Investigational Trial Intervention. | y |
| C218570 | 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding | Section 6.7 of the ICH M11 Protocol standard, Investigational Trial Intervention Assignment, Randomisation and Blinding. | y |
| C218571 | 6.7.1 Participant Assignment to Investigational Trial Intervention | Section 6.7.1 of the ICH M11 Protocol standard, Participant Assignment to Investigational Trial Intervention. | y |
| C218572 | 6.7.2 Randomisation | Section 6.7.2 of the ICH M11 Protocol standard, Randomisation. | y |
| C218573 | 6.7.3 Measures to Maintain Blinding | Section 6.7.3 of the ICH M11 Protocol standard, Measures to Maintain Blinding. | y |
| C218574 | 6.7.4 Emergency Unblinding at the Site | Section 6.7.4 of the ICH M11 Protocol standard, Emergency Unblinding at the Site. | y |
| C218575 | 6.8 Investigational Trial Intervention Adherence | Section 6.8 of the ICH M11 Protocol standard, Investigational Trial Intervention Adherence. | y |
| C218576 | 6.9 Description of Noninvestigational Trial Intervention | Section 6.9 of the ICH M11 Protocol standard, Description of Noninvestigational Trial Intervention. | y |
| C218577 | 6.9.1 Background Trial Intervention | Section 6.9.1 of the ICH M11 Protocol standard, Background Trial Intervention. | y |
| C218578 | 6.9.2 Rescue Therapy | Section 6.9.2 of the ICH M11 Protocol standard, Rescue Therapy. | y |
| C218579 | 6.9.3 Other Noninvestigational Trial Intervention | Section 6.9.3 of the ICH M11 Protocol standard, Other Noninvestigational Trial Intervention. | y |
| C218583 | 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL | Section 7 of the ICH M11 Protocol standard, PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL. | y |
| C218584 | 7.1 Discontinuation of Trial Intervention for Individual Participants | Section 7.1 of the ICH M11 Protocol standard, Discontinuation of Trial Intervention for Individual Participants. | y |
| C218585 | 7.1.1 Permanent Discontinuation of Trial Intervention | Section 7.1.1 of the ICH M11 Protocol standard, Permanent Discontinuation of Trial Intervention. | y |
| C218586 | 7.1.2 Temporary Discontinuation of Trial Intervention | Section 7.1.2 of the ICH M11 Protocol standard, Temporary Discontinuation of Trial Intervention. | y |
| C218587 | 7.1.3 Rechallenge | Section 7.1.3 of the ICH M11 Protocol standard, Rechallenge. | y |
| C218588 | 7.2 Participant Discontinuation or Withdrawal from the Trial | Section 7.2 of the ICH M11 Protocol standard, Participant Discontinuation or Withdrawal from the Trial. | y |
| C218589 | 7.3 Management of Loss to Follow-Up | Section 7.3 of the ICH M11 Protocol standard, Management of Loss to Follow-Up. | y |
| C218590 | 8 TRIAL ASSESSMENTS AND PROCEDURES | Section 8 of the ICH M11 Protocol standard, TRIAL ASSESSMENTS AND PROCEDURES. | y |
| C218591 | 8.1 Trial Assessments and Procedures Considerations | Section 8.1 of the ICH M11 Protocol standard, Trial Assessments and Procedures Considerations. | y |
| C218592 | 8.2 Screening/Baseline Assessments and Procedures | Section 8.2 of the ICH M11 Protocol standard, Screening/Baseline Assessments and Procedures. | y |
| C218593 | 8.3 Efficacy Assessments and Procedures | Section 8.3 of the ICH M11 Protocol standard, Efficacy Assessments and Procedures. | y |
| C218594 | 8.4 Safety Assessments and Procedures | Section 8.4 of the ICH M11 Protocol standard, Safety Assessments and Procedures. | y |
| C218595 | 8.4.1 Physical Examination | Section 8.4.1 of the ICH M11 Protocol standard, Physical Examination. | y |
| C218596 | 8.4.2 Vital Signs | Section 8.4.2 of the ICH M11 Protocol standard, Vital Signs. | y |
| C218597 | 8.4.3 Electrocardiograms | Section 8.4.3 of the ICH M11 Protocol standard, Electrocardiograms. | y |
| C218598 | 8.4.4 Clinical Laboratory Assessments | Section 8.4.4 of the ICH M11 Protocol standard, Clinical Laboratory Assessments. | y |
| C218599 | 8.4.5 Pregnancy Testing | Section 8.4.5 of the ICH M11 Protocol standard, Pregnancy Testing. | y |
| C218600 | 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring | Section 8.4.6 of the ICH M11 Protocol standard, Suicidal Ideation and Behaviour Risk Monitoring. | y |
| C218601 | 8.5 Pharmacokinetics | Section 8.5 of the ICH M11 Protocol standard, Pharmacokinetics. | y |
| C218602 | 8.6 Biomarkers | Section 8.6 of the ICH M11 Protocol standard, Biomarkers. | y |
| C218603 | 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics | Section 8.6.1 of the ICH M11 Protocol standard, Genetics, Genomics, Pharmacogenetics and Pharmacogenomics. | y |
| C218604 | 8.6.2 Pharmacodynamic Biomarkers | Section 8.6.2 of the ICH M11 Protocol standard, Pharmacodynamic Biomarkers. | y |
| C218605 | 8.6.3 Other Biomarkers | Section 8.6.3 of the ICH M11 Protocol standard, Other Biomarkers. | y |
| C218606 | 8.7 Immunogenicity Assessments | Section 8.7 of the ICH M11 Protocol standard, Immunogenicity Assessments. | y |
| C218607 | 8.8 Medical Resource Utilisation and Health Economics | Section 8.8 of the ICH M11 Protocol standard, Medical Resource Utilisation and Health Economics. | y |
| C218608 | 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS | Section 9 of the ICH M11 Protocol standard, ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS. | y |
| C218609 | 9.1 Definitions | Section 9.1 of the ICH M11 Protocol standard, Definitions. | y |
| C218610 | 9.1.1 Definitions of Adverse Events | Section 9.1.1 of the ICH M11 Protocol standard, Definitions of Adverse Events. | y |
| C218611 | 9.1.2 Definitions of Serious Adverse Events | Section 9.1.2 of the ICH M11 Protocol standard, Definitions of Serious Adverse Events. | y |
| C218612 | 9.1.3 Definitions of Product Complaints | Section 9.1.3 of the ICH M11 Protocol standard, Definitions of Product Complaints. | y |
| C218613 | 9.1.3.1 Definitions of Medical Device Product Complaints | Section 9.1.3.1 of the ICH M11 Protocol standard, Definitions of Medical Device Product Complaints. | y |
| C218614 | 9.2 Timing and Procedures for Collection and Reporting | Section 9.2 of the ICH M11 Protocol standard, Timing and Procedures for Collection and Reporting. | y |
| C218615 | 9.2.1 Timing | Section 9.2.1 of the ICH M11 Protocol standard, Timing. | y |
| C218616 | 9.2.2 Collection Procedures | Section 9.2.2 of the ICH M11 Protocol standard, Collection Procedures. | y |
| C218617 | 9.2.3 Reporting | Section 9.2.3 of the ICH M11 Protocol standard, Reporting. | y |
| C218618 | 9.2.3.1 Regulatory Reporting Requirements | Section 9.2.3.1 of the ICH M11 Protocol standard, Regulatory Reporting Requirements. | y |
| C218619 | 9.2.4 Adverse Events of Special Interest | Section 9.2.4 of the ICH M11 Protocol standard, Adverse Events of Special Interest. | y |
| C218620 | 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs | Section 9.2.5 of the ICH M11 Protocol standard, Disease-related Events or Outcomes Not Qualifying as AEs or SAEs. | y |
| C218621 | 9.3 Pregnancy and Postpartum Information | Section 9.3 of the ICH M11 Protocol standard, Pregnancy and Postpartum Information. | y |
| C218622 | 9.3.1 Participants Who Become Pregnant During the Trial | Section 9.3.1 of the ICH M11 Protocol standard, Participants Who Become Pregnant During the Trial. | y |
| C218623 | 9.3.2 Participants Whose Partners Become Pregnant During the Trial | Section 9.3.2 of the ICH M11 Protocol standard, Participants Whose Partners Become Pregnant During the Trial. | y |
| C218624 | 9.4 Special Safety Situations | Section 9.4 of the ICH M11 Protocol standard, Special Safety Situations. | y |
| C222770 | Amendment Details | Amendment Details Section of the ICH M11 Protocol standard, Amendment Details. | y |
| C222769 | Title Page | Title Page Section of the ICH M11 Protocol standard, Title Page. | y |
This file contains a code list co-maintained by ICH M2 ESTRI and CDISC in collaboration with the NCI Enterprise Vocabulary Services (EVS). It is encoded using OASIS genericode. More information on ICH technical standards is available via the M2 ESTRI webpages at www.ich.org.
Change History: v1.0 (November 11 2025)
Report created by ICH_M2_CDISC_Codelist.xsl : [Revision: 1.1 ] : ICH : Harmonisation for Better Health