Generated Narrative: ValueSet udp-section-codes-vs Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version ?1.0.0-ballot2 Code Display Definition C222769 ICH M11 Protocol Section Title Page Title Page Section of the ICH M11 Protocol standard, Title Page. C218514 ICH M11 Protocol Section 1 PROTOCOL SUMMARY The title of section 1 of the ICH M11 protocol guideline: PROTOCOL SUMMARY. C218515 ICH M11 Protocol Section 1.1 Protocol Synopsis The title of section 1.1 of the ICH M11 protocol guideline: Protocol Synopsis. C218516 ICH M11 Protocol Section 1.1.1 Primary and Secondary Objectives and Estimands The title of section 1.1.1 of the ICH M11 protocol guideline: Primary and Secondary Objectives and Estimands. C218517 ICH M11 Protocol Section 1.1.2 Overall Design The title of section 1.1.2 of the ICH M11 protocol guideline: Overall Design. C218518 ICH M11 Protocol Section 1.2 Trial Schema The title of section 1.2 of the ICH M11 protocol guideline: Trial Schema. C218519 ICH M11 Protocol Section 1.3 Schedule of Activities The title of section 1.3 of the ICH M11 protocol guideline: Schedule of Activities. C218520 ICH M11 Protocol Section 2 INTRODUCTION The title of section 2 of the ICH M11 protocol guideline: INTRODUCTION. C218521 ICH M11 Protocol Section 2.1 Purpose of Trial The title of section 2.1 of the ICH M11 protocol guideline: Purpose of Trial. C218522 ICH M11 Protocol Section 2.2 Assessment of Risks and Benefits The title of section 2.2 of the ICH M11 protocol guideline: Assessment of Risks and Benefits. C218523 ICH M11 Protocol Section 2.2.1 Risk Summary and Mitigation Strategy The title of section 2.2.2 of the ICH M11 protocol guideline: Risk Summary and Mitigation Strategy. C218524 ICH M11 Protocol Section 2.2.2 Benefit Summary The title of section 2.2.1 of the ICH M11 protocol guideline: Benefit Summary. C218525 ICH M11 Protocol Section 2.2.3 Overall Risk-Benefit Assessment The title of section 2.2.3 of the ICH M11 protocol guideline: Overall Risk-Benefit Assessment. C218526 ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS The title of section 3 of the ICH M11 protocol guideline: TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS. C218527 ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s) The title of section 3.1 of the ICH M11 protocol guideline: Primary Objective(s) and Associated Estimand(s). C218528 ICH M11 Protocol Section 3.1.1 Primary Objective The title of section 3.1.1 of the ICH M11 protocol guideline: Primary Objective. C218529 ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s) The title of section 3.2 of the ICH M11 protocol guideline: Secondary Objective(s) and Associated Estimand(s). C218530 ICH M11 Protocol Section 3.2.1 Secondary Objective The title of section 3.2.1 of the ICH M11 protocol guideline: Secondary Objective. C218531 ICH M11 Protocol Section 3.3 Exploratory Objective(s) The title of section 3.3 of the ICH M11 protocol guideline: Exploratory Objective(s). C218532 ICH M11 Protocol Section 3.3.1 Exploratory Objective The title of section 3.3.1 of the ICH M11 protocol guideline: Exploratory Objective. C218533 ICH M11 Protocol Section 4 TRIAL DESIGN The title of section 4 of the ICH M11 protocol guideline: TRIAL DESIGN. C218534 ICH M11 Protocol Section 4.1 Description of Trial Design The title of section 4.1 of the ICH M11 protocol guideline: Description of Trial Design. C218535 ICH M11 Protocol Section 4.1.1 Stakeholder Input into Design The title of section 4.1.1 of the ICH M11 protocol guideline: Stakeholder Input into Design. C218536 ICH M11 Protocol Section 4.2 Rationale for Trial Design The title of section 4.2 of the ICH M11 protocol guideline: Rationale for Trial Design. C218537 ICH M11 Protocol Section 4.2.1 Rationale for Estimand(s) The title of section 4.2.1 of the ICH M11 protocol guideline: Rationale for Estimand(s). C218538 ICH M11 Protocol Section 4.2.2 Rationale for Intervention Model The title of section 4.2.2 of the ICH M11 protocol guideline: Rationale for Intervention Model. C218539 ICH M11 Protocol Section 4.2.3 Rationale for Control Type The title of section 4.2.3 of the ICH M11 protocol guideline: Rationale for Control Type. C218540 ICH M11 Protocol Section 4.2.4 Rationale for Trial Duration The title of section 4.2.4 of the ICH M11 protocol guideline: Rationale for Trial Duration. C218541 ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial Design The title of section 4.2.5 of the ICH M11 protocol guideline: Rationale for Adaptive or Novel Trial Design. C218542 ICH M11 Protocol Section 4.2.6 Rationale for Interim Analysis The title of section 4.2.6 of the ICH M11 protocol guideline: Rationale for Interim Analysis. C218543 ICH M11 Protocol Section 4.2.7 Rationale for Other Trial Design Aspects The title of section 4.2.7 of the ICH M11 protocol guideline: Rationale for Other Trial Design Aspects. C218544 ICH M11 Protocol Section 4.3 Trial Stopping Rules The title of section 4.3 of the ICH M11 protocol guideline: Trial Stopping Rules. C218545 ICH M11 Protocol Section 4.4 Start of Trial and End of Trial The title of section 4.4 of the ICH M11 protocol guideline: Start of Trial and End of Trial. C218546 ICH M11 Protocol Section 4.5 Access to Trial Intervention After End of Trial The title of section 4.5 of the ICH M11 protocol guideline: Access to Trial Intervention After End of Trial. C218547 ICH M11 Protocol Section 5 TRIAL POPULATION The title of section 5 of the ICH M11 protocol guideline: TRIAL POPULATION. C218548 ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale The title of section 5.1 of the ICH M11 protocol guideline: Description of Trial Population and Rationale. C218549 ICH M11 Protocol Section 5.2 Inclusion Criteria The title of section 5.2 of the ICH M11 protocol guideline: Inclusion Criteria. C218550 ICH M11 Protocol Section 5.3 Exclusion Criteria The title of section 5.3 of the ICH M11 protocol guideline: Exclusion Criteria. C218551 ICH M11 Protocol Section 5.4 Contraception The title of section 5.4 of the ICH M11 protocol guideline: Contraception. C218552 ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential The title of section 5.4.1 of the ICH M11 protocol guideline: Definitions Related to Childbearing Potential. C218553 ICH M11 Protocol Section 5.4.2 Contraception Requirements The title of section 5.4.2 of the ICH M11 protocol guideline: Contraception Requirements. C218554 ICH M11 Protocol Section 5.5 Lifestyle Restrictions The title of section 5.5 of the ICH M11 protocol guideline: Lifestyle Restrictions. C218555 ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions The title of section 5.5.1 of the ICH M11 protocol guideline: Meals and Dietary Restrictions. C218556 ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions The title of section 5.5.2 of the ICH M11 protocol guideline: Caffeine, Alcohol, Tobacco, and Other Restrictions. C218557 ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions The title of section 5.5.3 of the ICH M11 protocol guideline: Physical Activity Restrictions. C218558 ICH M11 Protocol Section 5.5.4 Other Activity Restrictions The title of section 5.5.4 of the ICH M11 protocol guideline: Other Activity Restrictions. C218559 ICH M11 Protocol Section 5.6 Screen Failure and Rescreening The title of section 5.6 of the ICH M11 protocol guideline: Screen Failure and Rescreening. C218560 ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY The title of section 6 of the ICH M11 protocol guideline: TRIAL INTERVENTION AND CONCOMITANT THERAPY. C218561 ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention The title of section 6.1 of the ICH M11 protocol guideline: Description of Investigational Trial Intervention. C218562 ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen The title of section 6.2 of the ICH M11 protocol guideline: Rationale for Investigational Trial Intervention Dose and Regimen. C218563 ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration The title of section 6.3 of the ICH M11 protocol guideline: Investigational Trial Intervention Administration. C218564 ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification The title of section 6.4 of the ICH M11 protocol guideline: Investigational Trial Intervention Dose Modification. C218565 ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose The title of section 6.5 of the ICH M11 protocol guideline: Management of Investigational Trial Intervention Overdose. C218566 ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention The title of section 6.6 of the ICH M11 protocol guideline: Preparation, Storage, Handling and Accountability of Investigational Trial Intervention. C218567 ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention The title of section 6.6.1 of the ICH M11 protocol guideline: Preparation of Investigational Trial Intervention. C218568 ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention The title of section 6.6.2 of the ICH M11 protocol guideline: Storage and Handling of Investigational Trial Intervention. C218569 ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention The title of section 6.6.3 of the ICH M11 protocol guideline: Accountability of Investigational Trial Intervention. C218570 ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding The title of section 6.7 of the ICH M11 protocol guideline: Investigational Trial Intervention Assignment, Randomisation and Blinding. C218571 ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention The title of section 6.7.1 of the ICH M11 protocol guideline: Participant Assignment to Investigational Trial Intervention. C218572 ICH M11 Protocol Section 6.7.2 Randomisation The title of section 6.7.2 of the ICH M11 protocol guideline: Randomisation. C218573 ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding The title of section 6.7.3 of the ICH M11 protocol guideline: Measures to Maintain Blinding. C218574 ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site The title of section 6.7.4 of the ICH M11 protocol guideline: Emergency Unblinding at the Site. C218575 ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence The title of section 6.8 of the ICH M11 protocol guideline: Investigational Trial Intervention Adherence. C218576 ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention The title of section 6.9 of the ICH M11 protocol guideline: Description of Noninvestigational Trial Intervention. C218577 ICH M11 Protocol Section 6.9.1 Background Trial Intervention The title of section 6.9.1 of the ICH M11 protocol guideline: Background Trial Intervention. C218578 ICH M11 Protocol Section 6.9.2 Rescue Therapy The title of section 6.9.2 of the ICH M11 protocol guideline: Rescue Therapy. C218579 ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention The title of section 6.9.3 of the ICH M11 protocol guideline: Other Noninvestigational Trial Intervention. C218580 ICH M11 Protocol Section 6.10 Concomitant Therapy The title of section 6.10 of the ICH M11 protocol guideline: Concomitant Therapy. C218581 ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy The title of section 6.10.1 of the ICH M11 protocol guideline: Prohibited Concomitant Therapy. C218582 ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy The title of section 6.10.2 of the ICH M11 protocol guideline: Permitted Concomitant Therapy. C218583 ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL The title of section 7 of the ICH M11 protocol guideline: PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL. C218584 ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants The title of section 7.1 of the ICH M11 protocol guideline: Discontinuation of Trial Intervention for Individual Participants. C218585 ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention The title of section 7.1.1 of the ICH M11 protocol guideline: Permanent Discontinuation of Trial Intervention. C218586 ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention The title of section 7.1.2 of the ICH M11 protocol guideline: Temporary Discontinuation of Trial Intervention. C218587 ICH M11 Protocol Section 7.1.3 Rechallenge The title of section 7.1.3 of the ICH M11 protocol guideline: Rechallenge. C218588 ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial The title of section 7.2 of the ICH M11 protocol guideline: Participant Discontinuation or Withdrawal from the Trial. C218589 ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up The title of section 7.3 of the ICH M11 protocol guideline: Management of Loss to Follow-Up. C218590 ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES The title of section 8 of the ICH M11 protocol guideline: TRIAL ASSESSMENTS AND PROCEDURES. C218591 ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations The title of section 8.1 of the ICH M11 protocol guideline: Trial Assessments and Procedures Considerations. C218592 ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures The title of section 8.2 of the ICH M11 protocol guideline: Screening/Baseline Assessments and Procedures. C218593 ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures The title of section 8.3 of the ICH M11 protocol guideline: Efficacy Assessments and Procedures. C218594 ICH M11 Protocol Section 8.4 Safety Assessments and Procedures The title of section 8.4 of the ICH M11 protocol guideline: Safety Assessments and Procedures. C218595 ICH M11 Protocol Section 8.4.1 Physical Examination The title of section 8.4.1 of the ICH M11 protocol guideline: Physical Examination. C218596 ICH M11 Protocol Section 8.4.2 Vital Signs The title of section 8.4.2 of the ICH M11 protocol guideline: Vital Signs. C218597 ICH M11 Protocol Section 8.4.3 Electrocardiograms The title of section 8.4.3 of the ICH M11 protocol guideline: Electrocardiograms. C218598 ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments The title of section 8.4.4 of the ICH M11 protocol guideline: Clinical Laboratory Assessments. C218599 ICH M11 Protocol Section 8.4.5 Pregnancy Testing The title of section 8.4.5 of the ICH M11 protocol guideline: Pregnancy Testing. C218600 ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring The title of section 8.4.6 of the ICH M11 protocol guideline: Suicidal Ideation and Behaviour Risk Monitoring. C218601 ICH M11 Protocol Section 8.5 Pharmacokinetics The title of section 8.5 of the ICH M11 protocol guideline: Pharmacokinetics. C218602 ICH M11 Protocol Section 8.6 Biomarkers The title of section 8.6 of the ICH M11 protocol guideline: Biomarkers. C218603 ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics The title of section 8.6.1 of the ICH M11 protocol guideline: Genetics, Genomics, Pharmacogenetics and Pharmacogenomics. C218604 ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers The title of section 8.6.2 of the ICH M11 protocol guideline: Pharmacodynamic Biomarkers. C218605 ICH M11 Protocol Section 8.6.3 Other Biomarkers The title of section 8.6.3 of the ICH M11 protocol guideline: Other Biomarkers. C218606 ICH M11 Protocol Section 8.7 Immunogenicity Assessments The title of section 8.7 of the ICH M11 protocol guideline: Immunogenicity Assessments. C218607 ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics The title of section 8.8 of the ICH M11 protocol guideline: Medical Resource Utilisation and Health Economics. C218608 ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS The title of section 9 of the ICH M11 protocol guideline: ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS. C218609 ICH M11 Protocol Section 9.1 Definitions The title of section 9.1 of the ICH M11 protocol guideline: Definitions. C218610 ICH M11 Protocol Section 9.1.1 Definitions of Adverse Events The title of section 9.1.1 of the ICH M11 protocol guideline: Definitions of Adverse Events. C218611 ICH M11 Protocol Section 9.1.2 Definitions of Serious Adverse Events The title of section 9.1.2 of the ICH M11 protocol guideline: Definitions of Serious Adverse Events. C218612 ICH M11 Protocol Section 9.1.3 Definitions of Product Complaints The title of section 9.1.3 of the ICH M11 protocol guideline: Definitions of Product Complaints. C218613 ICH M11 Protocol Section 9.1.3.1 Definitions of Medical Device Product Complaints The title of section 9.1.3.1 of the ICH M11 protocol guideline: Definitions of Medical Device Product Complaints. C218614 ICH M11 Protocol Section 9.2 Timing and Procedures for Collection and Reporting The title of section 9.2 of the ICH M11 protocol guideline: Timing and Procedures for Collection and Reporting. C218615 ICH M11 Protocol Section 9.2.1 Timing The title of section 9.2.1 of the ICH M11 protocol guideline: Timing. C218616 ICH M11 Protocol Section 9.2.2 Collection Procedures The title of section 9.2.2 of the ICH M11 protocol guideline: Collection Procedures. C218617 ICH M11 Protocol Section 9.2.3 Reporting The title of section 9.2.3 of the ICH M11 protocol guideline: Reporting. C218618 ICH M11 Protocol Section 9.2.3.1 Regulatory Reporting Requirements The title of section 9.2.3.1 of the ICH M11 protocol guideline: Regulatory Reporting Requirements. C218619 ICH M11 Protocol Section 9.2.4 Adverse Events of Special Interest The title of section 9.2.4 of the ICH M11 protocol guideline: Adverse Events of Special Interest. C218620 ICH M11 Protocol Section 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs The title of section 9.2.5 of the ICH M11 protocol guideline: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs. C218621 ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information The title of section 9.3 of the ICH M11 protocol guideline: Pregnancy and Postpartum Information. C218622 ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the Trial The title of section 9.3.1 of the ICH M11 protocol guideline: Participants Who Become Pregnant During the Trial. C218623 ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the Trial The title of section 9.3.2 of the ICH M11 protocol guideline: Participants Whose Partners Become Pregnant During the Trial. C218624 ICH M11 Protocol Section 9.4 Special Safety Situations The title of section 9.4 of the ICH M11 protocol guideline: Special Safety Situations. C218625 ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS The title of section 10 of the ICH M11 protocol guideline: STATISTICAL CONSIDERATIONS. C218626 ICH M11 Protocol Section 10.1 General Considerations The title of section 10.1 of the ICH M11 protocol guideline: General Considerations. C218627 ICH M11 Protocol Section 10.2 Analysis Sets The title of section 10.2 of the ICH M11 protocol guideline: Analysis Sets. C218628 ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables The title of section 10.3 of the ICH M11 protocol guideline: Analyses of Demographics and Other Baseline Variables. C218629 ICH M11 Protocol Section 10.4 Analyses Associated with the Primary Objective(s) The title of section 10.4 of the ICH M11 protocol guideline: Analyses Associated with the Primary Objective(s). C218630 ICH M11 Protocol Section 10.4.1 Primary Objective The title of section 10.4.1 of the ICH M11 protocol guideline: Primary Objective. C218631 ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method The title of section 10.4.1.1 of the ICH M11 protocol guideline: Statistical Analysis Method. C218632 ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s) The title of section 10.4.1.2 of the ICH M11 protocol guideline: Handling of Data in Relation to Primary Estimand(s). C218633 ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s) The title of section 10.4.1.3 of the ICH M11 protocol guideline: Handling of Missing Data in Relation to Primary Estimand(s) C218634 ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis The title of section 10.4.1.4 of the ICH M11 protocol guideline: Sensitivity Analysis. C218635 ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis The title of section 10.4.1.5 of the ICH M11 protocol guideline: Supplementary Analysis. C218636 ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s) The title of section 10.5 of the ICH M11 protocol guideline: Analyses Associated with the Secondary Objective(s). C218637 ICH M11 Protocol Section 10.5.1 Secondary Objective The title of section 10.5.1 of the ICH M11 protocol guideline: Secondary Objective. C218638 ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method The title of section 10.5.1.1 of the ICH M11 protocol guideline: Statistical Analysis Method. C218639 ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s) The title of section 10.5.1.2 of the ICH M11 protocol guideline: Handling of Data in Relation to Secondary Estimand(s). C218640 ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s) The title of section 10.5.1.3 of the ICH M11 protocol guideline: Handling of Missing Data in Relation to Secondary Estimand(s). C218641 ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis The title of section 10.5.1.4 of the ICH M11 protocol guideline: Sensitivity Analysis. C218642 ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis The title of section 10.5.1.5 of the ICH M11 protocol guideline: Supplementary Analysis. C218643 ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s) The title of section 10.6 of the ICH M11 protocol guideline: Analyses Associated with the Exploratory Objective(s). C218644 ICH M11 Protocol Section 10.7 Safety Analyses The title of section 10.7 of the ICH M11 protocol guideline: Safety Analyses. C218645 ICH M11 Protocol Section 10.8 Other Analyses The title of section 10.8 of the ICH M11 protocol guideline: Other Analyses. C218646 ICH M11 Protocol Section 10.9 Interim Analyses The title of section 10.9 of the ICH M11 protocol guideline: Interim Analyses. C218647 ICH M11 Protocol Section 10.10 Multiplicity Adjustments The title of section 10.10 of the ICH M11 protocol guideline: Multiplicity Adjustments. C218648 ICH M11 Protocol Section 10.11 Sample Size Determination The title of section 10.11 of the ICH M11 protocol guideline: Sample Size Determination. C218649 ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS The title of section 11 of the ICH M11 protocol guideline: TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS. C218650 ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations The title of section 11.1 of the ICH M11 protocol guideline: Regulatory and Ethical Considerations. C218651 ICH M11 Protocol Section 11.2 Trial Oversight The title of section 11.2 of the ICH M11 protocol guideline: Trial Oversight. C218652 ICH M11 Protocol Section 11.2.1 Investigator Responsibilities The title of section 11.2.1 of the ICH M11 protocol guideline: Investigator Responsibilities. C218653 ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities The title of section 11.2.2 of the ICH M11 protocol guideline: Sponsor Responsibilities. C218654 ICH M11 Protocol Section 11.3 Informed Consent Process The title of section 11.3 of the ICH M11 protocol guideline: Informed Consent Process. C218655 ICH M11 Protocol Section 11.3.1 Informed Consent for Rescreening The title of section 11.3.1 of the ICH M11 protocol guideline: Informed Consent for Rescreening. C218656 ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research The title of section 11.3.2 of the ICH M11 protocol guideline: Informed Consent for Use of Remaining Samples in Exploratory Research. C218657 ICH M11 Protocol Section 11.4 Committees The title of section 11.4 of the ICH M11 protocol guideline: Committees. C218658 ICH M11 Protocol Section 11.5 Insurance and Indemnity The title of section 11.5 of the ICH M11 protocol guideline: Insurance and Indemnity. C218659 ICH M11 Protocol Section 11.6 Risk-Based Quality Management The title of section 11.6 of the ICH M11 protocol guideline: Risk-Based Quality Management. C218660 ICH M11 Protocol Section 11.7 Data Governance The title of section 11.7 of the ICH M11 protocol guideline: Data Governance. C218661 ICH M11 Protocol Section 11.8 Data Protection The title of section 11.8 of the ICH M11 protocol guideline: Data Protection. C218662 ICH M11 Protocol Section 11.9 Source Records The title of section 11.9 of the ICH M11 protocol guideline: Source Records. C218663 ICH M11 Protocol Section 11.10 Protocol Deviations The title of section 11.10 of the ICH M11 protocol guideline: Protocol Deviations. C218664 ICH M11 Protocol Section 11.11 Early Site Closure The title of section 11.11 of the ICH M11 protocol guideline: Early Site Closure. C218665 ICH M11 Protocol Section 11.12 Data Dissemination The title of section 11.12 of the ICH M11 protocol guideline: Data Dissemination. C218666 ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS The title of section 12 of the ICH M11 protocol guideline: APPENDIX: SUPPORTING DETAILS. C218667 ICH M11 Protocol Section 12.1 Clinical Laboratory Tests The title of section 12.1 of the ICH M11 protocol guideline: Clinical Laboratory Tests. C218668 ICH M11 Protocol Section 12.2 Country/Region-Specific Differences The title of section 12.2 of the ICH M11 protocol guideline: Country/Region-Specific Differences. C218669 ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s) The title of section 12.3 of the ICH M11 protocol guideline: Prior Protocol Amendment(s). C218670 ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS The title of section 13 of the ICH M11 protocol guideline: APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS. C218671 ICH M11 Protocol Section 14 APPENDIX: REFERENCES The title of section 14 of the ICH M11 protocol guideline: APPENDIX: REFERENCES.
HL7 International / Biomedical Research and Regulation
Codes representing sections of M11. This value set is not identified in the M11 specification but is in the NCI Thesaurus and was originally specified for M11. It is NCI Value Set C217272 drawn from the NCI Thesaurus and represented here in FHIR format. These codes are present in UDP to allow granularity in narrative compositions.
Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license For more licensing information and links see: [licenses.html](licenses.html)
ICH M11 Protocol Section 1 PROTOCOL SUMMARY
ICH M11 Protocol Section 1.1 Protocol Synopsis
ICH M11 Protocol Section 1.1.1 Primary and Secondary Objectives and Estimands
ICH M11 Protocol Section 1.1.2 Overall Design
ICH M11 Protocol Section 1.2 Trial Schema
ICH M11 Protocol Section 1.3 Schedule of Activities
ICH M11 Protocol Section 2.1 Purpose of Trial
ICH M11 Protocol Section 2.2 Assessment of Risks and Benefits
ICH M11 Protocol Section 2.2.1 Risk Summary and Mitigation Strategy
ICH M11 Protocol Section 2.2.2 Benefit Summary
ICH M11 Protocol Section 2.2.3 Overall Risk-Benefit Assessment
ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS
ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s)
ICH M11 Protocol Section 3.1.1 Primary Objective
ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s)
ICH M11 Protocol Section 3.2.1 Secondary Objective
ICH M11 Protocol Section 3.3 Exploratory Objective(s)
ICH M11 Protocol Section 3.3.1 Exploratory Objective
ICH M11 Protocol Section 4.1 Description of Trial Design
ICH M11 Protocol Section 4.1.1 Stakeholder Input into Design
ICH M11 Protocol Section 4.2 Rationale for Trial Design
ICH M11 Protocol Section 4.2.1 Rationale for Estimand(s)
ICH M11 Protocol Section 4.2.2 Rationale for Intervention Model
ICH M11 Protocol Section 4.2.3 Rationale for Control Type
ICH M11 Protocol Section 4.2.4 Rationale for Trial Duration
ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial Design
ICH M11 Protocol Section 4.2.6 Rationale for Interim Analysis
ICH M11 Protocol Section 4.2.7 Rationale for Other Trial Design Aspects
ICH M11 Protocol Section 4.3 Trial Stopping Rules
ICH M11 Protocol Section 4.4 Start of Trial and End of Trial
ICH M11 Protocol Section 4.5 Access to Trial Intervention After End of Trial
ICH M11 Protocol Section 5 TRIAL POPULATION
ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale
ICH M11 Protocol Section 5.2 Inclusion Criteria
ICH M11 Protocol Section 5.3 Exclusion Criteria
ICH M11 Protocol Section 5.4 Contraception
ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential
ICH M11 Protocol Section 5.4.2 Contraception Requirements
ICH M11 Protocol Section 5.5 Lifestyle Restrictions
ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions
ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions
ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions
ICH M11 Protocol Section 5.5.4 Other Activity Restrictions
ICH M11 Protocol Section 5.6 Screen Failure and Rescreening
ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY
ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention
ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen
ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration
ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification
ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose
ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention
ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention
ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention
ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention
ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding
ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention
ICH M11 Protocol Section 6.7.2 Randomisation
ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding
ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site
ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence
ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention
ICH M11 Protocol Section 6.9.1 Background Trial Intervention
ICH M11 Protocol Section 6.9.2 Rescue Therapy
ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention
ICH M11 Protocol Section 6.10 Concomitant Therapy
ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy
ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy
ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL
ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants
ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention
ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention
ICH M11 Protocol Section 7.1.3 Rechallenge
ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial
ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up
ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations
ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures
ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures
ICH M11 Protocol Section 8.4 Safety Assessments and Procedures
ICH M11 Protocol Section 8.4.1 Physical Examination
ICH M11 Protocol Section 8.4.2 Vital Signs
ICH M11 Protocol Section 8.4.3 Electrocardiograms
ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments
ICH M11 Protocol Section 8.4.5 Pregnancy Testing
ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring
ICH M11 Protocol Section 8.5 Pharmacokinetics
ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics
ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers
ICH M11 Protocol Section 8.6.3 Other Biomarkers
ICH M11 Protocol Section 8.7 Immunogenicity Assessments
ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics
ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS
ICH M11 Protocol Section 9.1 Definitions
ICH M11 Protocol Section 9.1.1 Definitions of Adverse Events
ICH M11 Protocol Section 9.1.2 Definitions of Serious Adverse Events
ICH M11 Protocol Section 9.1.3 Definitions of Product Complaints
ICH M11 Protocol Section 9.1.3.1 Definitions of Medical Device Product Complaints
ICH M11 Protocol Section 9.2 Timing and Procedures for Collection and Reporting
ICH M11 Protocol Section 9.2.2 Collection Procedures
ICH M11 Protocol Section 9.2.3 Reporting
ICH M11 Protocol Section 9.2.3.1 Regulatory Reporting Requirements
ICH M11 Protocol Section 9.2.4 Adverse Events of Special Interest
ICH M11 Protocol Section 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information
ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the Trial
ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the Trial
ICH M11 Protocol Section 9.4 Special Safety Situations
ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS
ICH M11 Protocol Section 10.1 General Considerations
ICH M11 Protocol Section 10.2 Analysis Sets
ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables
ICH M11 Protocol Section 10.4 Analyses Associated with the Primary Objective(s)
ICH M11 Protocol Section 10.4.1 Primary Objective
ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method
ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)
ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)
ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis
ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis
ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)
ICH M11 Protocol Section 10.5.1 Secondary Objective
ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method
ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)
ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)
ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis
ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis
ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)
ICH M11 Protocol Section 10.7 Safety Analyses
ICH M11 Protocol Section 10.8 Other Analyses
ICH M11 Protocol Section 10.9 Interim Analyses
ICH M11 Protocol Section 10.10 Multiplicity Adjustments
ICH M11 Protocol Section 10.11 Sample Size Determination
ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations
ICH M11 Protocol Section 11.2 Trial Oversight
ICH M11 Protocol Section 11.2.1 Investigator Responsibilities
ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities
ICH M11 Protocol Section 11.3 Informed Consent Process
ICH M11 Protocol Section 11.3.1 Informed Consent for Rescreening
ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research
ICH M11 Protocol Section 11.4 Committees
ICH M11 Protocol Section 11.5 Insurance and Indemnity
ICH M11 Protocol Section 11.6 Risk-Based Quality Management
ICH M11 Protocol Section 11.7 Data Governance
ICH M11 Protocol Section 11.8 Data Protection
ICH M11 Protocol Section 11.9 Source Records
ICH M11 Protocol Section 11.10 Protocol Deviations
ICH M11 Protocol Section 11.11 Early Site Closure
ICH M11 Protocol Section 11.12 Data Dissemination
ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS
ICH M11 Protocol Section 12.1 Clinical Laboratory Tests
ICH M11 Protocol Section 12.2 Country/Region-Specific Differences
ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s)
ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS
ICH M11 Protocol Section 14 APPENDIX: REFERENCES