Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist (Short Name) CDISC Codelist (Long Name) Change Summary Original New Change Implementation Instructions 2025-12-19 N/A Add C217274 Term Amendment Details Statement Response Terminology Amendment Details Statement Response Terminology Add new codelist - - - Amendment Details Statement Response Terminology 2025-12-19 N/A Add C218486 Term Amendment Details Statement Response Terminology Amendment Details Statement Response Terminology Add new term to new codelist - - - This is the first protocol amendment. 2025-12-19 N/A Add C218487 Term Amendment Details Statement Response Terminology Amendment Details Statement Response Terminology Add new term to new codelist - - - This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s). 2025-12-19 N/A Add C218488 Term Amendment Details Statement Response Terminology Amendment Details Statement Response Terminology Add new term to new codelist - - - This protocol has been amended previously. The Protocol Amendment Summary of Changes for the current amendment is located directly before the Table of Contents. Prior amendment(s) to this protocol are listed in the table below, beginning with the most recent. 2025-12-19 N/A Add C218485 Term Amendment Details Statement Response Terminology Amendment Details Statement Response Terminology Add new term to new codelist - - - This protocol has not been amended. 2025-12-19 N/A Add C217275 Term Amendment Scope Enrollment Description Response Terminology Amendment Scope Enrollment Description Response Terminology Add new codelist - - - Amendment Scope Enrollment Description Response Terminology 2025-12-19 N/A Add C218489 Term Amendment Scope Enrollment Description Response Terminology Amendment Scope Enrollment Description Response Terminology Add new term to new codelist - - - By Cohort 2025-12-19 N/A Add C68846 Term Amendment Scope Enrollment Description Response Terminology Amendment Scope Enrollment Description Response Terminology Add new term to new codelist - - - Globally 2025-12-19 N/A Add C41065 Term Amendment Scope Enrollment Description Response Terminology Amendment Scope Enrollment Description Response Terminology Add new term to new codelist - - - Locally 2025-12-19 N/A Add C217047 Term Amendment Scope Response Terminology Amendment Scope Response Terminology Add new codelist - - - Amendment Scope Response Terminology 2025-12-19 N/A Add C68846 Term Amendment Scope Response Terminology Amendment Scope Response Terminology Add new term to new codelist - - - Global 2025-12-19 N/A Add C217026 Term Amendment Scope Response Terminology Amendment Scope Response Terminology Add new term to new codelist - - - Not Global 2025-12-19 N/A Add C217279 Term Control Type Response Terminology Control Type Response Terminology Add new codelist - - - Control Type Response Terminology 2025-12-19 N/A Add C49649 Term Control Type Response Terminology Control Type Response Terminology Add new term to new codelist - - - Active Comparator 2025-12-19 N/A Add C218505 Term Control Type Response Terminology Control Type Response Terminology Add new term to new codelist - - - Different Dose or Regimen 2025-12-19 N/A Add C120841 Term Control Type Response Terminology Control Type Response Terminology Add new term to new codelist - - - Dose Response 2025-12-19 N/A Add C218506 Term Control Type Response Terminology Control Type Response Terminology Add new term to new codelist - - - External 2025-12-19 N/A Add C28280 Term Control Type Response Terminology Control Type Response Terminology Add new term to new codelist - - - No Control 2025-12-19 N/A Add C49648 Term Control Type Response Terminology Control Type Response Terminology Add new term to new codelist - - - Placebo 2025-12-19 N/A Add C184727 Term Control Type Response Terminology Control Type Response Terminology Add new term to new codelist - - - Sham Procedure 2025-12-19 N/A Add C217342 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new codelist - - - ICH M11 Section 1 Terminology 2025-12-19 N/A Add C218706 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Adaptive Trial Design Indicator 2025-12-19 N/A Add C218838 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Additional Description of Duration 2025-12-19 N/A Add C218714 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Alternate Description of Planned Duration of Trial Intervention 2025-12-19 N/A Add C218717 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Alternate Description of Planned Duration of Trial Participation 2025-12-19 N/A Add C218709 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Blinded Roles 2025-12-19 N/A Add C49647 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Control Type 2025-12-19 N/A Add C218708 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Drug/Device Combination Product Indicator 2025-12-19 N/A Add C218718 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Independent Committees 2025-12-19 N/A Add C142585 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - INN 2025-12-19 N/A Add C218475 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Intervention Assignment Method 2025-12-19 N/A Add C98746 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Intervention Model 2025-12-19 N/A Add C218707 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Master Protocol Indicator 2025-12-19 N/A Add C49694 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Maximum Age 2025-12-19 N/A Add C49693 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Minimum Age 2025-12-19 N/A Add C97054 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Nonproprietary Name(s) 2025-12-19 N/A Add C98771 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Number of Arms 2025-12-19 N/A Add C49692 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Number of Participants 2025-12-19 N/A Add C218719 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Other Committees 2025-12-19 N/A Add C223138 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Other Intervention Assignment Method 2025-12-19 N/A Add C112038 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Population Diagnosis or Condition 2025-12-19 N/A Add C218703 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Population Type 2025-12-19 N/A Add C218839 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Primary and Secondary Objectives and Estimands 2025-12-19 N/A Add C223137 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Randomisation Type 2025-12-19 N/A Add C218711 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - randomly assigned to trial intervention/enrolled 2025-12-19 N/A Add C132349 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Schedule of Activities 2025-12-19 N/A Add C218720 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Schema Notes 2025-12-19 N/A Add C218704 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Site Distribution 2025-12-19 N/A Add C218705 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Site Geographic Scope 2025-12-19 N/A Add C223136 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Stratification Indicator 2025-12-19 N/A Add C218710 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Target/Maximum 2025-12-19 N/A Add C218713 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - total planned duration of trial intervention unit of time 2025-12-19 N/A Add C218712 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - total planned duration of trial intervention 2025-12-19 N/A Add C218716 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - total planned duration of trial participation unit of time 2025-12-19 N/A Add C218715 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - total planned duration of trial participation 2025-12-19 N/A Add C49658 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Trial Blind Schema 2025-12-19 N/A Add C93682 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Trial Schema 2025-12-19 N/A Add C50400 Term ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Add new term to new codelist - - - Units of Age 2025-12-19 N/A Add C217351 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new codelist - - - ICH M11 Section 10 Terminology 2025-12-19 N/A Add C218807 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Analyses Associated with the Exploratory Objective(s) 2025-12-19 N/A Add C218802 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Analyses of Demographics and Other Baseline Variables 2025-12-19 N/A Add C218801 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Analysis Sets 2025-12-19 N/A Add C164387 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - General Considerations 2025-12-19 N/A Add C218803 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Handling of Data in Relation to Primary Estimand(s) 2025-12-19 N/A Add C218805 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Handling of Data in Relation to Secondary Estimand(s) 2025-12-19 N/A Add C218804 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Handling of Missing Data in Relation to Primary Estimand(s) 2025-12-19 N/A Add C218806 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Handling of Missing Data in Relation to Secondary Estimand(s) 2025-12-19 N/A Add C142582 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Interim Analyses 2025-12-19 N/A Add C218810 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Multiplicity Adjustments 2025-12-19 N/A Add C218809 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Other Analyses 2025-12-19 N/A Add C218808 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Safety Analyses 2025-12-19 N/A Add C115467 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Sample Size Determination 2025-12-19 N/A Add C218480 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Sensitivity Analysis 2025-12-19 N/A Add C218482 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Statistical Analysis Method 2025-12-19 N/A Add C218481 Term ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Add new term to new codelist - - - Supplementary Analysis 2025-12-19 N/A Add C217352 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new codelist - - - ICH M11 Section 11 Terminology 2025-12-19 N/A Add C218819 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Committees 2025-12-19 N/A Add C218829 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Criteria for Early Closure 2025-12-19 N/A Add C218831 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Data Dissemination 2025-12-19 N/A Add C218822 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Data Governance 2025-12-19 N/A Add C218823 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Data Protection 2025-12-19 N/A Add C218828 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Decision Rights for Site Closure 2025-12-19 N/A Add C218815 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Description of Assent Process 2025-12-19 N/A Add C218816 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Description of Emergency Consent Process 2025-12-19 N/A Add C184390 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Description of Informed Consent Process 2025-12-19 N/A Add C222675 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Identification of Source Records 2025-12-19 N/A Add C218817 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Informed Consent for Rescreening 2025-12-19 N/A Add C218818 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Informed Consent for Use of Remaining Samples in Exploratory Research 2025-12-19 N/A Add C218820 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Insurance and Indemnity 2025-12-19 N/A Add C218825 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Investigator Expectations for Source Records 2025-12-19 N/A Add C218813 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Investigator Responsibilities 2025-12-19 N/A Add C218827 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Protocol Deviations 2025-12-19 N/A Add C218811 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Regulatory and Ethical Considerations 2025-12-19 N/A Add C218830 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Responsibilities Following Early Site Closure 2025-12-19 N/A Add C218821 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Risk-Based Quality Management 2025-12-19 N/A Add C218824 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Source Records Introduction 2025-12-19 N/A Add C218814 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Sponsor Responsibilities 2025-12-19 N/A Add C218826 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Trial Monitor Expectations for Source Records 2025-12-19 N/A Add C218812 Term ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Add new term to new codelist - - - Trial Oversight 2025-12-19 N/A Add C217353 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new codelist - - - ICH M11 Section 12 Terminology 2025-12-19 N/A Add C220640 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - Additional Appendices 2025-12-19 N/A Add C218477 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - Amendment Identifier 2025-12-19 N/A Add C218695 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - Amendment Scope Enrollment Description 2025-12-19 N/A Add C218478 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - Approximately <#/%> enrolled 2025-12-19 N/A Add C181233 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - Brief Rationale for Change 2025-12-19 N/A Add C25294 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - Clinical Laboratory Tests 2025-12-19 N/A Add C218832 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - Country/Region Identifier 2025-12-19 N/A Add C218834 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - Country/Region Specific Protocol Clarifications 2025-12-19 N/A Add C218833 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - Country/Region-Specific Requirements 2025-12-19 N/A Add C218483 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - Description of Change 2025-12-19 N/A Add C218835 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - Prior Protocol Amendment(s) 2025-12-19 N/A Add C218479 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - Section # and Name 2025-12-19 N/A Add C218836 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - specify alternative location 2025-12-19 N/A Add C132352 Term ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Add new term to new codelist - - - Sponsor Approval Date 2025-12-19 N/A Add C217354 Term ICH M11 Section 13 Terminology ICH M11 Section 13 Terminology Add new codelist - - - ICH M11 Section 13 Terminology 2025-12-19 N/A Add C218837 Term ICH M11 Section 13 Terminology ICH M11 Section 13 Terminology Add new term to new codelist - - - Glossary of Terms and Abbreviations 2025-12-19 N/A Add C217355 Term ICH M11 Section 14 Terminology ICH M11 Section 14 Terminology Add new codelist - - - ICH M11 Section 14 Terminology 2025-12-19 N/A Add C184397 Term ICH M11 Section 14 Terminology ICH M11 Section 14 Terminology Add new term to new codelist - - - References 2025-12-19 N/A Add C217343 Term ICH M11 Section 2 Terminology ICH M11 Section 2 Terminology Add new codelist - - - ICH M11 Section 2 Terminology 2025-12-19 N/A Add C218724 Term ICH M11 Section 2 Terminology ICH M11 Section 2 Terminology Add new term to new codelist - - - Benefit Summary 2025-12-19 N/A Add C218725 Term ICH M11 Section 2 Terminology ICH M11 Section 2 Terminology Add new term to new codelist - - - Overall Risk-Benefit Assessment 2025-12-19 N/A Add C146997 Term ICH M11 Section 2 Terminology ICH M11 Section 2 Terminology Add new term to new codelist - - - Purpose of Trial 2025-12-19 N/A Add C218721 Term ICH M11 Section 2 Terminology ICH M11 Section 2 Terminology Add new term to new codelist - - - Trial-specific Intervention Risks and Mitigations 2025-12-19 N/A Add C218723 Term ICH M11 Section 2 Terminology ICH M11 Section 2 Terminology Add new term to new codelist - - - Trial-specific Other Risks and Mitigations 2025-12-19 N/A Add C218722 Term ICH M11 Section 2 Terminology ICH M11 Section 2 Terminology Add new term to new codelist - - - Trial-specific Procedure Risks and Mitigations 2025-12-19 N/A Add C217344 Term ICH M11 Section 3 Terminology ICH M11 Section 3 Terminology Add new codelist - - - ICH M11 Section 3 Terminology 2025-12-19 N/A Add C188856 Term ICH M11 Section 3 Terminology ICH M11 Section 3 Terminology Add new term to new codelist - - - Description of Intercurrent Event 2025-12-19 N/A Add C25212 Term ICH M11 Section 3 Terminology ICH M11 Section 3 Terminology Add new term to new codelist - - - Endpoint 2025-12-19 N/A Add C163559 Term ICH M11 Section 3 Terminology ICH M11 Section 3 Terminology Add new term to new codelist - - - Exploratory Objective 2025-12-19 N/A Add C188857 Term ICH M11 Section 3 Terminology ICH M11 Section 3 Terminology Add new term to new codelist - - - Intercurrent Event Strategy 2025-12-19 N/A Add C70833 Term ICH M11 Section 3 Terminology ICH M11 Section 3 Terminology Add new term to new codelist - - - Population 2025-12-19 N/A Add C188853 Term ICH M11 Section 3 Terminology ICH M11 Section 3 Terminology Add new term to new codelist - - - Population-level Summary 2025-12-19 N/A Add C85826 Term ICH M11 Section 3 Terminology ICH M11 Section 3 Terminology Add new term to new codelist - - - Primary Objective 2025-12-19 N/A Add C85827 Term ICH M11 Section 3 Terminology ICH M11 Section 3 Terminology Add new term to new codelist - - - Secondary Objective 2025-12-19 N/A Add C49236 Term ICH M11 Section 3 Terminology ICH M11 Section 3 Terminology Add new term to new codelist - - - Treatment 2025-12-19 N/A Add C217345 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new codelist - - - ICH M11 Section 4 Terminology 2025-12-19 N/A Add C218738 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Access to Trial Intervention After End of Trial 2025-12-19 N/A Add C218728 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Additional Description of Trial Design 2025-12-19 N/A Add C218727 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Description of Level and Method of Blinding 2025-12-19 N/A Add C219658 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Description of Method of Assignment to Trial Intervention 2025-12-19 N/A Add C218726 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Description of Trial Duration 2025-12-19 N/A Add C218737 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - End of Trial 2025-12-19 N/A Add C147139 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Overall Description of Trial Design and Description of Intervention Model 2025-12-19 N/A Add C142705 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Overall Rationale for Trial Design 2025-12-19 N/A Add C218733 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Rationale for Adaptive or Novel Trial Design 2025-12-19 N/A Add C218731 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Rationale for Control Type 2025-12-19 N/A Add C218730 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Rationale for Estimand(s) 2025-12-19 N/A Add C218734 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Rationale for Interim Analysis 2025-12-19 N/A Add C215629 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Rationale for Intervention Model 2025-12-19 N/A Add C218735 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Rationale for Other Trial Design Aspects 2025-12-19 N/A Add C218732 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Rationale for Trial Duration 2025-12-19 N/A Add C218729 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Stakeholder Input into Design 2025-12-19 N/A Add C218736 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Start of Trial 2025-12-19 N/A Add C142698 Term ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Add new term to new codelist - - - Trial Stopping Rules 2025-12-19 N/A Add C217346 Term ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Add new codelist - - - ICH M11 Section 5 Terminology 2025-12-19 N/A Add C218744 Term ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Add new term to new codelist - - - Caffeine, Alcohol, Tobacco, and Other Restrictions 2025-12-19 N/A Add C218741 Term ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Add new term to new codelist - - - Contraception Requirements 2025-12-19 N/A Add C218740 Term ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Add new term to new codelist - - - Definitions Related to Childbearing Potential 2025-12-19 N/A Add C218739 Term ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Add new term to new codelist - - - Description of Trial Population and Rationale 2025-12-19 N/A Add C25370 Term ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Add new term to new codelist - - - Exclusion Criterion 2025-12-19 N/A Add C25532 Term ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Add new term to new codelist - - - Inclusion Criterion 2025-12-19 N/A Add C218742 Term ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Add new term to new codelist - - - Lifestyle Restrictions 2025-12-19 N/A Add C218743 Term ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Add new term to new codelist - - - Meals and Dietary Restrictions 2025-12-19 N/A Add C218746 Term ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Add new term to new codelist - - - Other Activity Restrictions 2025-12-19 N/A Add C218745 Term ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Add new term to new codelist - - - Physical Activity Restrictions 2025-12-19 N/A Add C179373 Term ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Add new term to new codelist - - - Rescreening 2025-12-19 N/A Add C49628 Term ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Add new term to new codelist - - - Screen Failure 2025-12-19 N/A Add C217347 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new codelist - - - ICH M11 Section 6 Terminology 2025-12-19 N/A Add C176267 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Accountability of Investigational Trial Intervention 2025-12-19 N/A Add C93729 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Arm Name 2025-12-19 N/A Add C172457 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Arm Type 2025-12-19 N/A Add C222329 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Background Trial Intervention 2025-12-19 N/A Add C53630 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Concomitant Therapy 2025-12-19 N/A Add C218751 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Description of Investigational Trial Intervention 2025-12-19 N/A Add C218759 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Description of Noninvestigational Trial Intervention 2025-12-19 N/A Add C218747 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - description of the overview of trial interventions or a heading for the optional table 2025-12-19 N/A Add C94394 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Dosage Level(s) 2025-12-19 N/A Add C142517 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Dosage Strength(s) 2025-12-19 N/A Add C218757 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Emergency Unblinding at the Site 2025-12-19 N/A Add C218749 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - IMP or NIMP 2025-12-19 N/A Add C177930 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Intervention Name 2025-12-19 N/A Add C98747 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Intervention Type 2025-12-19 N/A Add C218758 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Investigational Trial Intervention Adherence 2025-12-19 N/A Add C218753 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Investigational Trial Intervention Administration 2025-12-19 N/A Add C218754 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Investigational Trial Intervention Dose Modification 2025-12-19 N/A Add C218755 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Management of Investigational Trial Intervention Overdose 2025-12-19 N/A Add C189349 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Measures to Maintain Blinding 2025-12-19 N/A Add C218761 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Other Noninvestigational Trial Intervention 2025-12-19 N/A Add C218756 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Participant Assignment to Investigational Trial Intervention 2025-12-19 N/A Add C218763 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Permitted Concomitant Therapy 2025-12-19 N/A Add C42636 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Pharmaceutical Dose Form 2025-12-19 N/A Add C176274 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Preparation of Investigational Trial Intervention 2025-12-19 N/A Add C218762 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Prohibited Concomitant Therapy 2025-12-19 N/A Add C25196 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Randomisation 2025-12-19 N/A Add C218752 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Rationale for Investigational Trial Intervention Dose and Regimen 2025-12-19 N/A Add C15697 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Regimen/Treatment Period/Vaccination Regimen 2025-12-19 N/A Add C222330 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Rescue Therapy 2025-12-19 N/A Add C38114 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Route of Administration 2025-12-19 N/A Add C218750 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Sourcing 2025-12-19 N/A Add C115525 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Storage and Handling of Investigational Trial Intervention 2025-12-19 N/A Add C218748 Term ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Add new term to new codelist - - - Use 2025-12-19 N/A Add C217348 Term ICH M11 Section 7 Terminology ICH M11 Section 7 Terminology Add new codelist - - - ICH M11 Section 7 Terminology 2025-12-19 N/A Add C218768 Term ICH M11 Section 7 Terminology ICH M11 Section 7 Terminology Add new term to new codelist - - - Management of Loss to Follow-Up 2025-12-19 N/A Add C218767 Term ICH M11 Section 7 Terminology ICH M11 Section 7 Terminology Add new term to new codelist - - - Participant Discontinuation or Withdrawal from Trial 2025-12-19 N/A Add C218764 Term ICH M11 Section 7 Terminology ICH M11 Section 7 Terminology Add new term to new codelist - - - Permanent Discontinuation of Trial Intervention 2025-12-19 N/A Add C218766 Term ICH M11 Section 7 Terminology ICH M11 Section 7 Terminology Add new term to new codelist - - - Rechallenge 2025-12-19 N/A Add C218765 Term ICH M11 Section 7 Terminology ICH M11 Section 7 Terminology Add new term to new codelist - - - Temporary Discontinuation of Trial Intervention 2025-12-19 N/A Add C217349 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new codelist - - - ICH M11 Section 8 Terminology 2025-12-19 N/A Add C218771 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Baseline Assessments and Procedures 2025-12-19 N/A Add C218774 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Clinical Laboratory Assessments 2025-12-19 N/A Add C218772 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Efficacy Assessments and Procedures 2025-12-19 N/A Add C168186 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Electrocardiograms 2025-12-19 N/A Add C218777 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Genetics, Genomics, Pharmacogenetics and Pharmacogenomics 2025-12-19 N/A Add C218780 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Immunogenicity Assessments 2025-12-19 N/A Add C176849 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Medical Resource Utilisation and Health Economics 2025-12-19 N/A Add C218779 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Other Biomarkers 2025-12-19 N/A Add C218778 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Pharmacodynamic Biomarkers 2025-12-19 N/A Add C218776 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Pharmacokinetics 2025-12-19 N/A Add C20989 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Physical Examination 2025-12-19 N/A Add C92949 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Pregnancy Testing 2025-12-19 N/A Add C218773 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Safety Assessments and Procedures 2025-12-19 N/A Add C218770 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Screening Assessments and Procedures 2025-12-19 N/A Add C218775 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Suicidal Ideation and Behaviour Risk Monitoring 2025-12-19 N/A Add C218769 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Trial Assessments and Procedures Considerations 2025-12-19 N/A Add C154628 Term ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Add new term to new codelist - - - Vital Signs 2025-12-19 N/A Add C217350 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new codelist - - - ICH M11 Section 9 Terminology 2025-12-19 N/A Add C217358 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Adverse Events of Special Interest 2025-12-19 N/A Add C218790 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Back-up Method for Reporting 2025-12-19 N/A Add C82552 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Causality 2025-12-19 N/A Add C218476 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Definitions of Adverse Events 2025-12-19 N/A Add C218783 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Definitions of Medical Device Product Complaints 2025-12-19 N/A Add C218782 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Definitions of Product Complaints 2025-12-19 N/A Add C218781 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Definitions of Serious Adverse Events 2025-12-19 N/A Add C218797 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Disease-related Events or Outcomes Not Qualifying as AEs or SAEs 2025-12-19 N/A Add C218791 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Event Collection and Reporting Timing 2025-12-19 N/A Add C218784 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Event Type 2025-12-19 N/A Add C218794 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Follow-up 2025-12-19 N/A Add C218792 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Identification 2025-12-19 N/A Add C218789 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Method for Reporting 2025-12-19 N/A Add C222263 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Other Event Type 2025-12-19 N/A Add C218798 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Participants Who Become Pregnant During the Trial 2025-12-19 N/A Add C218799 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Participants Whose Partners Become Pregnant During the Trial 2025-12-19 N/A Add C218793 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Recording 2025-12-19 N/A Add C218796 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Regulatory Reporting Requirements 2025-12-19 N/A Add C218787 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Reportable Period End 2025-12-19 N/A Add C218786 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Reportable Period Start 2025-12-19 N/A Add C218795 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Reporting 2025-12-19 N/A Add C25676 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Severity 2025-12-19 N/A Add C218785 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Situational Scope 2025-12-19 N/A Add C218800 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Special Safety Situations 2025-12-19 N/A Add C218788 Term ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Add new term to new codelist - - - Timing for Reporting to Sponsor or Designee 2025-12-19 N/A Add C217357 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new codelist - - - ICH M11 Section Amendment Details Terminology 2025-12-19 N/A Add C218694 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new term to new codelist - - - Amendment Details 2025-12-19 N/A Add C218695 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new term to new codelist - - - Amendment Scope Enrollment Definition 2025-12-19 N/A Add C42581 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new term to new codelist - - - Amendment Summary 2025-12-19 N/A Add C218478 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new term to new codelist - - - Approximately <#/%> enrolled 2025-12-19 N/A Add C181233 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new term to new codelist - - - Brief Rationale for Change 2025-12-19 N/A Add C218701 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new term to new codelist - - - Briefly Explain Substantial Impact on Data 2025-12-19 N/A Add C218699 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new term to new codelist - - - Briefly Explain Substantial Impact On Safety 2025-12-19 N/A Add C218483 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new term to new codelist - - - Description of Change 2025-12-19 N/A Add C218700 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new term to new codelist - - - Is this amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial? 2025-12-19 N/A Add C218698 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new term to new codelist - - - Is this amendment likely to have a substantial impact on the safety or rights of the participants? 2025-12-19 N/A Add C218696 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new term to new codelist - - - Primary Reason for Amendment 2025-12-19 N/A Add C218697 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new term to new codelist - - - Secondary Reason for Amendment 2025-12-19 N/A Add C218479 Term ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Add new term to new codelist - - - Section # and Name 2025-12-19 N/A Add C217356 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new codelist - - - ICH M11 Section Title Page Terminology 2025-12-19 N/A Add C218477 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Amendment Identifier 2025-12-19 N/A Add C218673 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Amendment Scope 2025-12-19 N/A Add C132352 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Approval Date 2025-12-19 N/A Add C218679 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Co-Sponsor Legal Address 2025-12-19 N/A Add C218678 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Co-Sponsor Name 2025-12-19 N/A Add C20108 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Country Identifier 2025-12-19 N/A Add C218683 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Device Manufacturer Legal Address 2025-12-19 N/A Add C218682 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Device Manufacturer Name 2025-12-19 N/A Add C218684 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - EU CT Number 2025-12-19 N/A Add C218685 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - FDA IND Number 2025-12-19 N/A Add C132346 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Full Title 2025-12-19 N/A Add C218686 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - IDE Number 2025-12-19 N/A Add C218687 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - jRCT Number 2025-12-19 N/A Add C218681 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Local Sponsor Legal Address 2025-12-19 N/A Add C218680 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Local Sponsor Name 2025-12-19 N/A Add C218693 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Medical Expert contact information (as designated by sponsor) 2025-12-19 N/A Add C172240 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - NCT Number 2025-12-19 N/A Add C218688 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - NMPA IND Number 2025-12-19 N/A Add C97054 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Nonproprietary Name(s) 2025-12-19 N/A Add C218672 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Original Protocol Indicator 2025-12-19 N/A Add C218690 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Other Regulatory or Clinical Trial Identifier 2025-12-19 N/A Add C71898 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Proprietary Name(s) 2025-12-19 N/A Add C218674 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Region Identifier 2025-12-19 N/A Add C83081 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Site Identifier 2025-12-19 N/A Add C181236 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Sponsor Confidentiality Statement 2025-12-19 N/A Add C218677 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Sponsor Legal Address 2025-12-19 N/A Add C222495 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Sponsor Name 2025-12-19 N/A Add C132351 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Sponsor Protocol Identifier 2025-12-19 N/A Add C222014 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - sponsor signatory (e.g., name, title, signature and date) 2025-12-19 N/A Add C218675 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Sponsor's Investigational Product Code(s) 2025-12-19 N/A Add C222063 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - state location where Medical Expert contact information can be found 2025-12-19 N/A Add C218484 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - State location where sponsor approval information can be found 2025-12-19 N/A Add C222064 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - state location where sponsor signatory information can be found (e.g., electronic signature) 2025-12-19 N/A Add C94108 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Trial Acronym 2025-12-19 N/A Add C48281 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Trial Phase 2025-12-19 N/A Add C94105 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Trial Short Title 2025-12-19 N/A Add C93813 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Version Date 2025-12-19 N/A Add C181232 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - Version Number 2025-12-19 N/A Add C218689 Term ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Add new term to new codelist - - - WHO/UTN Number 2025-12-19 N/A Add C217282 Term Independent Committee Name Response Terminology Independent Committee Name Response Terminology Add new codelist - - - Independent Committee Name Response Terminology 2025-12-19 N/A Add C215671 Term Independent Committee Name Response Terminology Independent Committee Name Response Terminology Add new term to new codelist - - - Dose Escalation Committee 2025-12-19 N/A Add C78726 Term Independent Committee Name Response Terminology Independent Committee Name Response Terminology Add new term to new codelist - - - Endpoint Adjudication Committee 2025-12-19 N/A Add C142578 Term Independent Committee Name Response Terminology Independent Committee Name Response Terminology Add new term to new codelist - - - Independent Data Monitoring Committee 2025-12-19 N/A Add C41132 Term Independent Committee Name Response Terminology Independent Committee Name Response Terminology Add new term to new codelist - - - None 2025-12-19 N/A Add C17649 Term Independent Committee Name Response Terminology Independent Committee Name Response Terminology Add new term to new codelist - - - Other 2025-12-19 N/A Add C217277 Term Intervention Model Response Terminology Intervention Model Response Terminology Add new codelist - - - Intervention Model Response Terminology 2025-12-19 N/A Add C82637 Term Intervention Model Response Terminology Intervention Model Response Terminology Add new term to new codelist - - - Cross-over 2025-12-19 N/A Add C82638 Term Intervention Model Response Terminology Intervention Model Response Terminology Add new term to new codelist - - - Factorial 2025-12-19 N/A Add C17649 Term Intervention Model Response Terminology Intervention Model Response Terminology Add new term to new codelist - - - Other 2025-12-19 N/A Add C82639 Term Intervention Model Response Terminology Intervention Model Response Terminology Add new term to new codelist - - - Parallel Group 2025-12-19 N/A Add C142568 Term Intervention Model Response Terminology Intervention Model Response Terminology Add new term to new codelist - - - Sequential 2025-12-19 N/A Add C82640 Term Intervention Model Response Terminology Intervention Model Response Terminology Add new term to new codelist - - - Single Group 2025-12-19 N/A Add C217284 Term Intervention Type Response Terminology Intervention Type Response Terminology Add new codelist - - - Intervention Type Response Terminology 2025-12-19 N/A Add C15184 Term Intervention Type Response Terminology Intervention Type Response Terminology Add new term to new codelist - - - Behavioural 2025-12-19 N/A Add C307 Term Intervention Type Response Terminology Intervention Type Response Terminology Add new term to new codelist - - - Biologic 2025-12-19 N/A Add C54696 Term Intervention Type Response Terminology Intervention Type Response Terminology Add new term to new codelist - - - Combination Product 2025-12-19 N/A Add C18020 Term Intervention Type Response Terminology Intervention Type Response Terminology Add new term to new codelist - - - Diagnostic 2025-12-19 N/A Add C1505 Term Intervention Type Response Terminology Intervention Type Response Terminology Add new term to new codelist - - - Dietary Supplement 2025-12-19 N/A Add C1909 Term Intervention Type Response Terminology Intervention Type Response Terminology Add new term to new codelist - - - Drug 2025-12-19 N/A Add C15238 Term Intervention Type Response Terminology Intervention Type Response Terminology Add new term to new codelist - - - Genetic 2025-12-19 N/A Add C16830 Term Intervention Type Response Terminology Intervention Type Response Terminology Add new term to new codelist - - - Medical Device 2025-12-19 N/A Add C218507 Term Intervention Type Response Terminology Intervention Type Response Terminology Add new term to new codelist - - - Non-Surgical Procedure 2025-12-19 N/A Add C15313 Term Intervention Type Response Terminology Intervention Type Response Terminology Add new term to new codelist - - - Radiation 2025-12-19 N/A Add C15329 Term Intervention Type Response Terminology Intervention Type Response Terminology Add new term to new codelist - - - Surgery 2025-12-19 N/A Add C923 Term Intervention Type Response Terminology Intervention Type Response Terminology Add new term to new codelist - - - Vaccine 2025-12-19 N/A Add C217285 Term Intervention Use Response Terminology Intervention Use Response Terminology Add new codelist - - - Intervention Use Response Terminology 2025-12-19 N/A Add C207614 Term Intervention Use Response Terminology Intervention Use Response Terminology Add new term to new codelist - - - Additional Required Treatment 2025-12-19 N/A Add C165822 Term Intervention Use Response Terminology Intervention Use Response Terminology Add new term to new codelist - - - Background Treatment 2025-12-19 N/A Add C158128 Term Intervention Use Response Terminology Intervention Use Response Terminology Add new term to new codelist - - - Challenge Agent 2025-12-19 N/A Add C18020 Term Intervention Use Response Terminology Intervention Use Response Terminology Add new term to new codelist - - - Diagnostic 2025-12-19 N/A Add C41161 Term Intervention Use Response Terminology Intervention Use Response Terminology Add new term to new codelist - - - Experimental Intervention 2025-12-19 N/A Add C753 Term Intervention Use Response Terminology Intervention Use Response Terminology Add new term to new codelist - - - Placebo 2025-12-19 N/A Add C165835 Term Intervention Use Response Terminology Intervention Use Response Terminology Add new term to new codelist - - - Rescue Medicine 2025-12-19 N/A Add C217052 Term Investigational Intervention Sourcing Response Terminology Investigational Intervention Sourcing Response Terminology Add new codelist - - - Investigational Intervention Sourcing Response Terminology 2025-12-19 N/A Add C215659 Term Investigational Intervention Sourcing Response Terminology Investigational Intervention Sourcing Response Terminology Add new term to new codelist - - - Centrally Sourced 2025-12-19 N/A Add C215660 Term Investigational Intervention Sourcing Response Terminology Investigational Intervention Sourcing Response Terminology Add new term to new codelist - - - Locally Sourced 2025-12-19 N/A Add C217286 Term Investigational Medicinal Product Indicator Response Terminology Investigational Medicinal Product Indicator Response Terminology Add new codelist - - - Investigational Medicinal Product Indicator Response Terminology 2025-12-19 N/A Add C202579 Term Investigational Medicinal Product Indicator Response Terminology Investigational Medicinal Product Indicator Response Terminology Add new term to new codelist - - - IMP 2025-12-19 N/A Add C156473 Term Investigational Medicinal Product Indicator Response Terminology Investigational Medicinal Product Indicator Response Terminology Add new term to new codelist - - - NIMP 2025-12-19 N/A Add C217046 Term No Yes Response Terminology No Yes Response Terminology Add new codelist - - - No Yes Response Terminology 2025-12-19 N/A Add C49487 Term No Yes Response Terminology No Yes Response Terminology Add new term to new codelist - - - No 2025-12-19 N/A Add C49488 Term No Yes Response Terminology No Yes Response Terminology Add new term to new codelist - - - Yes 2025-12-19 N/A Add C217278 Term Population Type Response Terminology Population Type Response Terminology Add new codelist - - - Population Type Response Terminology 2025-12-19 N/A Add C218503 Term Population Type Response Terminology Population Type Response Terminology Add new term to new codelist - - - With Disease 2025-12-19 N/A Add C218504 Term Population Type Response Terminology Population Type Response Terminology Add new term to new codelist - - - Without Disease 2025-12-19 N/A Add C217272 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new codelist - - - Protocol Section Name and Number Response Terminology 2025-12-19 N/A Add C218514 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 1 PROTOCOL SUMMARY 2025-12-19 N/A Add C218515 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 1.1 Protocol Synopsis 2025-12-19 N/A Add C218516 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 1.1.1 Primary and Secondary Objectives and Estimands 2025-12-19 N/A Add C218517 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 1.1.2 Overall Design 2025-12-19 N/A Add C218518 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 1.2 Trial Schema 2025-12-19 N/A Add C218519 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 1.3 Schedule of Activities 2025-12-19 N/A Add C218625 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10 STATISTICAL CONSIDERATIONS 2025-12-19 N/A Add C218626 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.1 General Considerations 2025-12-19 N/A Add C218647 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.10 Multiplicity Adjustments 2025-12-19 N/A Add C218648 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.11 Sample Size Determination 2025-12-19 N/A Add C218627 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.2 Analysis Sets 2025-12-19 N/A Add C218628 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.3 Analyses of Demographics and Other Baseline Variables 2025-12-19 N/A Add C218629 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.4 Analyses Associated with the Primary Objective(s) 2025-12-19 N/A Add C218630 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.4.1 Primary Objective 2025-12-19 N/A Add C218631 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.4.1.1 Statistical Analysis Method 2025-12-19 N/A Add C218632 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.4.1.2 Handling of Data in Relation to Primary Estimand(s) 2025-12-19 N/A Add C218633 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s) 2025-12-19 N/A Add C218634 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.4.1.4 Sensitivity Analysis 2025-12-19 N/A Add C218635 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.4.1.5 Supplementary Analysis 2025-12-19 N/A Add C218636 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.5 Analyses Associated with the Secondary Objective(s) 2025-12-19 N/A Add C218637 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.5.1 Secondary Objective 2025-12-19 N/A Add C218638 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.5.1.1 Statistical Analysis Method 2025-12-19 N/A Add C218639 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s) 2025-12-19 N/A Add C218640 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s) 2025-12-19 N/A Add C218641 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.5.1.4 Sensitivity Analysis 2025-12-19 N/A Add C218642 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.5.1.5 Supplementary Analysis 2025-12-19 N/A Add C218643 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.6 Analyses Associated with the Exploratory Objective(s) 2025-12-19 N/A Add C218644 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.7 Safety Analyses 2025-12-19 N/A Add C218645 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.8 Other Analyses 2025-12-19 N/A Add C218646 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 10.9 Interim Analyses 2025-12-19 N/A Add C218649 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS 2025-12-19 N/A Add C218650 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.1 Regulatory and Ethical Considerations 2025-12-19 N/A Add C218663 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.10 Protocol Deviations 2025-12-19 N/A Add C218664 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.11 Early Site Closure 2025-12-19 N/A Add C218665 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.12 Data Dissemination 2025-12-19 N/A Add C218651 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.2 Trial Oversight 2025-12-19 N/A Add C218652 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.2.1 Investigator Responsibilities 2025-12-19 N/A Add C218653 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.2.2 Sponsor Responsibilities 2025-12-19 N/A Add C218654 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.3 Informed Consent Process 2025-12-19 N/A Add C218655 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.3.1 Informed Consent for Rescreening 2025-12-19 N/A Add C218656 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research 2025-12-19 N/A Add C218657 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.4 Committees 2025-12-19 N/A Add C218658 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.5 Insurance and Indemnity 2025-12-19 N/A Add C218659 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.6 Risk-Based Quality Management 2025-12-19 N/A Add C218660 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.7 Data Governance 2025-12-19 N/A Add C218661 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.8 Data Protection 2025-12-19 N/A Add C218662 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 11.9 Source Records 2025-12-19 N/A Add C218666 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 12 APPENDIX: SUPPORTING DETAILS 2025-12-19 N/A Add C218667 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 12.1 Clinical Laboratory Tests 2025-12-19 N/A Add C218668 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 12.2 Country/Region-Specific Differences 2025-12-19 N/A Add C218669 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 12.3 Prior Protocol Amendment(s) 2025-12-19 N/A Add C218670 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS 2025-12-19 N/A Add C218671 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 14 APPENDIX: REFERENCES 2025-12-19 N/A Add C218520 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 2 INTRODUCTION 2025-12-19 N/A Add C218521 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 2.1 Purpose of Trial 2025-12-19 N/A Add C218522 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 2.2 Assessment of Risks and Benefits 2025-12-19 N/A Add C218523 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 2.2.1 Risk Summary and Mitigation Strategy 2025-12-19 N/A Add C218524 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 2.2.2 Benefit Summary 2025-12-19 N/A Add C218525 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 2.2.3 Overall Risk-Benefit Assessment 2025-12-19 N/A Add C218526 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS 2025-12-19 N/A Add C218527 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 3.1 Primary Objective(s) and Associated Estimand(s) 2025-12-19 N/A Add C218528 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 3.1.1 Primary Objective 2025-12-19 N/A Add C218529 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 3.2 Secondary Objective(s) and Associated Estimand(s) 2025-12-19 N/A Add C218530 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 3.2.1 Secondary Objective 2025-12-19 N/A Add C218531 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 3.3 Exploratory Objective(s) 2025-12-19 N/A Add C218532 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 3.3.1 Exploratory Objective 2025-12-19 N/A Add C218533 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4 TRIAL DESIGN 2025-12-19 N/A Add C218534 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4.1 Description of Trial Design 2025-12-19 N/A Add C218535 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4.1.1 Stakeholder Input into Design 2025-12-19 N/A Add C218536 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4.2 Rationale for Trial Design 2025-12-19 N/A Add C218537 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4.2.1 Rationale for Estimand(s) 2025-12-19 N/A Add C218538 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4.2.2 Rationale for Intervention Model 2025-12-19 N/A Add C218539 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4.2.3 Rationale for Control Type 2025-12-19 N/A Add C218540 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4.2.4 Rationale for Trial Duration 2025-12-19 N/A Add C218541 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4.2.5 Rationale for Adaptive or Novel Trial Design 2025-12-19 N/A Add C218542 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4.2.6 Rationale for Interim Analysis 2025-12-19 N/A Add C218543 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4.2.7 Rationale for Other Trial Design Aspects 2025-12-19 N/A Add C218544 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4.3 Trial Stopping Rules 2025-12-19 N/A Add C218545 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4.4 Start of Trial and End of Trial 2025-12-19 N/A Add C218546 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 4.5 Access to Trial Intervention After End of Trial 2025-12-19 N/A Add C218547 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 5 TRIAL POPULATION 2025-12-19 N/A Add C218548 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 5.1 Description of Trial Population and Rationale 2025-12-19 N/A Add C218549 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 5.2 Inclusion Criteria 2025-12-19 N/A Add C218550 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 5.3 Exclusion Criteria 2025-12-19 N/A Add C218551 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 5.4 Contraception 2025-12-19 N/A Add C218552 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 5.4.1 Definitions Related to Childbearing Potential 2025-12-19 N/A Add C218553 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 5.4.2 Contraception Requirements 2025-12-19 N/A Add C218554 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 5.5 Lifestyle Restrictions 2025-12-19 N/A Add C218555 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 5.5.1 Meals and Dietary Restrictions 2025-12-19 N/A Add C218556 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions 2025-12-19 N/A Add C218557 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 5.5.3 Physical Activity Restrictions 2025-12-19 N/A Add C218558 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 5.5.4 Other Activity Restrictions 2025-12-19 N/A Add C218559 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 5.6 Screen Failure and Rescreening 2025-12-19 N/A Add C218560 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY 2025-12-19 N/A Add C218561 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.1 Description of Investigational Trial Intervention 2025-12-19 N/A Add C218580 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.10 Concomitant Therapy 2025-12-19 N/A Add C218581 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.10.1 Prohibited Concomitant Therapy 2025-12-19 N/A Add C218582 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.10.2 Permitted Concomitant Therapy 2025-12-19 N/A Add C218562 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.2 Rationale for Investigational Trial Intervention Dose and Regimen 2025-12-19 N/A Add C218563 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.3 Investigational Trial Intervention Administration 2025-12-19 N/A Add C218564 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.4 Investigational Trial Intervention Dose Modification 2025-12-19 N/A Add C218565 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.5 Management of Investigational Trial Intervention Overdose 2025-12-19 N/A Add C218566 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention 2025-12-19 N/A Add C218567 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.6.1 Preparation of Investigational Trial Intervention 2025-12-19 N/A Add C218568 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.6.2 Storage and Handling of Investigational Trial Intervention 2025-12-19 N/A Add C218569 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.6.3 Accountability of Investigational Trial Intervention 2025-12-19 N/A Add C218570 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding 2025-12-19 N/A Add C218571 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.7.1 Participant Assignment to Investigational Trial Intervention 2025-12-19 N/A Add C218572 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.7.2 Randomisation 2025-12-19 N/A Add C218573 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.7.3 Measures to Maintain Blinding 2025-12-19 N/A Add C218574 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.7.4 Emergency Unblinding at the Site 2025-12-19 N/A Add C218575 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.8 Investigational Trial Intervention Adherence 2025-12-19 N/A Add C218576 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.9 Description of Noninvestigational Trial Intervention 2025-12-19 N/A Add C218577 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.9.1 Background Trial Intervention 2025-12-19 N/A Add C218578 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.9.2 Rescue Therapy 2025-12-19 N/A Add C218579 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 6.9.3 Other Noninvestigational Trial Intervention 2025-12-19 N/A Add C218583 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL 2025-12-19 N/A Add C218584 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 7.1 Discontinuation of Trial Intervention for Individual Participants 2025-12-19 N/A Add C218585 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 7.1.1 Permanent Discontinuation of Trial Intervention 2025-12-19 N/A Add C218586 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 7.1.2 Temporary Discontinuation of Trial Intervention 2025-12-19 N/A Add C218587 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 7.1.3 Rechallenge 2025-12-19 N/A Add C218588 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 7.2 Participant Discontinuation or Withdrawal from the Trial 2025-12-19 N/A Add C218589 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 7.3 Management of Loss to Follow-Up 2025-12-19 N/A Add C218590 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8 TRIAL ASSESSMENTS AND PROCEDURES 2025-12-19 N/A Add C218591 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.1 Trial Assessments and Procedures Considerations 2025-12-19 N/A Add C218592 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.2 Screening/Baseline Assessments and Procedures 2025-12-19 N/A Add C218593 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.3 Efficacy Assessments and Procedures 2025-12-19 N/A Add C218594 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.4 Safety Assessments and Procedures 2025-12-19 N/A Add C218595 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.4.1 Physical Examination 2025-12-19 N/A Add C218596 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.4.2 Vital Signs 2025-12-19 N/A Add C218597 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.4.3 Electrocardiograms 2025-12-19 N/A Add C218598 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.4.4 Clinical Laboratory Assessments 2025-12-19 N/A Add C218599 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.4.5 Pregnancy Testing 2025-12-19 N/A Add C218600 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring 2025-12-19 N/A Add C218601 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.5 Pharmacokinetics 2025-12-19 N/A Add C218602 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.6 Biomarkers 2025-12-19 N/A Add C218603 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics 2025-12-19 N/A Add C218604 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.6.2 Pharmacodynamic Biomarkers 2025-12-19 N/A Add C218605 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.6.3 Other Biomarkers 2025-12-19 N/A Add C218606 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.7 Immunogenicity Assessments 2025-12-19 N/A Add C218607 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 8.8 Medical Resource Utilisation and Health Economics 2025-12-19 N/A Add C218608 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS 2025-12-19 N/A Add C218609 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.1 Definitions 2025-12-19 N/A Add C218610 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.1.1 Definitions of Adverse Events 2025-12-19 N/A Add C218611 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.1.2 Definitions of Serious Adverse Events 2025-12-19 N/A Add C218612 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.1.3 Definitions of Product Complaints 2025-12-19 N/A Add C218613 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.1.3.1 Definitions of Medical Device Product Complaints 2025-12-19 N/A Add C218614 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.2 Timing and Procedures for Collection and Reporting 2025-12-19 N/A Add C218615 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.2.1 Timing 2025-12-19 N/A Add C218616 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.2.2 Collection Procedures 2025-12-19 N/A Add C218617 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.2.3 Reporting 2025-12-19 N/A Add C218618 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.2.3.1 Regulatory Reporting Requirements 2025-12-19 N/A Add C218619 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.2.4 Adverse Events of Special Interest 2025-12-19 N/A Add C218620 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs 2025-12-19 N/A Add C218621 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.3 Pregnancy and Postpartum Information 2025-12-19 N/A Add C218622 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.3.1 Participants Who Become Pregnant During the Trial 2025-12-19 N/A Add C218623 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.3.2 Participants Whose Partners Become Pregnant During the Trial 2025-12-19 N/A Add C218624 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - 9.4 Special Safety Situations 2025-12-19 N/A Add C222770 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - Amendment Details 2025-12-19 N/A Add C222769 Term Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Add new term to new codelist - - - Title Page 2025-12-19 N/A Add C217276 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new codelist - - - Reason for Amendment Response Terminology 2025-12-19 N/A Add C218497 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - Change In Standard Of Care 2025-12-19 N/A Add C218496 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - Change In Strategy 2025-12-19 N/A Add C218495 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - IMP Addition 2025-12-19 N/A Add C218501 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - Inconsistency And/Or Error In The Protocol 2025-12-19 N/A Add C218499 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - Investigator/Site Feedback 2025-12-19 N/A Add C218492 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - IRB/IEC Feedback 2025-12-19 N/A Add C218494 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - Manufacturing Change 2025-12-19 N/A Add C218498 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - New Data Available (Other Than Safety Data) 2025-12-19 N/A Add C218491 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - New Regulatory Guidance 2025-12-19 N/A Add C218493 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - New Safety Information Available 2025-12-19 N/A Add C48660 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - Not Applicable 2025-12-19 N/A Add C17649 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - Other 2025-12-19 N/A Add C218502 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - Protocol Design Error 2025-12-19 N/A Add C218500 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - Recruitment Difficulty 2025-12-19 N/A Add C218490 Term Reason for Amendment Response Terminology Reason for Amendment Response Terminology Add new term to new codelist - - - Regulatory Agency Request To Amend 2025-12-19 N/A Add C217283 Term Trial Arm Type Response Terminology Trial Arm Type Response Terminology Add new codelist - - - Trial Arm Type Response Terminology 2025-12-19 N/A Add C174267 Term Trial Arm Type Response Terminology Trial Arm Type Response Terminology Add new term to new codelist - - - Active Comparator Arm 2025-12-19 N/A Add C174226 Term Trial Arm Type Response Terminology Trial Arm Type Response Terminology Add new term to new codelist - - - Control Arm 2025-12-19 N/A Add C174266 Term Trial Arm Type Response Terminology Trial Arm Type Response Terminology Add new term to new codelist - - - Experimental Arm 2025-12-19 N/A Add C174270 Term Trial Arm Type Response Terminology Trial Arm Type Response Terminology Add new term to new codelist - - - No Intervention Arm 2025-12-19 N/A Add C174268 Term Trial Arm Type Response Terminology Trial Arm Type Response Terminology Add new term to new codelist - - - Placebo Comparator Arm 2025-12-19 N/A Add C174269 Term Trial Arm Type Response Terminology Trial Arm Type Response Terminology Add new term to new codelist - - - Sham Comparator Arm 2025-12-19 N/A Add C217281 Term Trial Blinding Role Response Terminology Trial Blinding Role Response Terminology Add new codelist - - - Trial Blinding Role Response Terminology 2025-12-19 N/A Add C17445 Term Trial Blinding Role Response Terminology Trial Blinding Role Response Terminology Add new term to new codelist - - - Care Provider 2025-12-19 N/A Add C25936 Term Trial Blinding Role Response Terminology Trial Blinding Role Response Terminology Add new term to new codelist - - - Investigator 2025-12-19 N/A Add C48660 Term Trial Blinding Role Response Terminology Trial Blinding Role Response Terminology Add new term to new codelist - - - Not Applicable 2025-12-19 N/A Add C207599 Term Trial Blinding Role Response Terminology Trial Blinding Role Response Terminology Add new term to new codelist - - - Outcomes Assessor 2025-12-19 N/A Add C142710 Term Trial Blinding Role Response Terminology Trial Blinding Role Response Terminology Add new term to new codelist - - - Participant 2025-12-19 N/A Add C70793 Term Trial Blinding Role Response Terminology Trial Blinding Role Response Terminology Add new term to new codelist - - - Sponsor 2025-12-19 N/A Add C217051 Term Trial Blinding Schema Response Terminology Trial Blinding Schema Response Terminology Add new codelist - - - Trial Blinding Schema Response Terminology 2025-12-19 N/A Add C15228 Term Trial Blinding Schema Response Terminology Trial Blinding Schema Response Terminology Add new term to new codelist - - - Double Blind 2025-12-19 N/A Add C187674 Term Trial Blinding Schema Response Terminology Trial Blinding Schema Response Terminology Add new term to new codelist - - - Observer Blind 2025-12-19 N/A Add C49659 Term Trial Blinding Schema Response Terminology Trial Blinding Schema Response Terminology Add new term to new codelist - - - Open Label 2025-12-19 N/A Add C28233 Term Trial Blinding Schema Response Terminology Trial Blinding Schema Response Terminology Add new term to new codelist - - - Single Blind 2025-12-19 N/A Add C217280 Term Trial Intervention Assignment Method Response Terminology Trial Intervention Assignment Method Response Terminology Add new codelist - - - Trial Intervention Assignment Method Response Terminology 2025-12-19 N/A Add C222801 Term Trial Intervention Assignment Method Response Terminology Trial Intervention Assignment Method Response Terminology Add new term to new codelist - - - No Intervention Assignment Method 2025-12-19 N/A Add C17649 Term Trial Intervention Assignment Method Response Terminology Trial Intervention Assignment Method Response Terminology Add new term to new codelist - - - Other 2025-12-19 N/A Add C25196 Term Trial Intervention Assignment Method Response Terminology Trial Intervention Assignment Method Response Terminology Add new term to new codelist - - - Randomisation 2025-12-19 N/A Add C217045 Term Trial Phase Response Terminology Trial Phase Response Terminology Add new codelist - - - Trial Phase Response Terminology 2025-12-19 N/A Add C54721 Term Trial Phase Response Terminology Trial Phase Response Terminology Add new term to new codelist - - - Early Phase 1 2025-12-19 N/A Add C15600 Term Trial Phase Response Terminology Trial Phase Response Terminology Add new term to new codelist - - - Phase 1 2025-12-19 N/A Add C15693 Term Trial Phase Response Terminology Trial Phase Response Terminology Add new term to new codelist - - - Phase 1/Phase 2 2025-12-19 N/A Add C198366 Term Trial Phase Response Terminology Trial Phase Response Terminology Add new term to new codelist - - - Phase 1/Phase 2/Phase 3 2025-12-19 N/A Add C198367 Term Trial Phase Response Terminology Trial Phase Response Terminology Add new term to new codelist - - - Phase 1/Phase 3 2025-12-19 N/A Add C15601 Term Trial Phase Response Terminology Trial Phase Response Terminology Add new term to new codelist - - - Phase 2 2025-12-19 N/A Add C15694 Term Trial Phase Response Terminology Trial Phase Response Terminology Add new term to new codelist - - - Phase 2/Phase 3 2025-12-19 N/A Add C217024 Term Trial Phase Response Terminology Trial Phase Response Terminology Add new term to new codelist - - - Phase 2/Phase 3/Phase 4 2025-12-19 N/A Add C15602 Term Trial Phase Response Terminology Trial Phase Response Terminology Add new term to new codelist - - - Phase 3 2025-12-19 N/A Add C217025 Term Trial Phase Response Terminology Trial Phase Response Terminology Add new term to new codelist - - - Phase 3/Phase 4 2025-12-19 N/A Add C15603 Term Trial Phase Response Terminology Trial Phase Response Terminology Add new term to new codelist - - - Phase 4 2025-12-19 N/A Add C217049 Term Trial Site Distribution Response Terminology Trial Site Distribution Response Terminology Add new codelist - - - Trial Site Distribution Response Terminology 2025-12-19 N/A Add C217005 Term Trial Site Distribution Response Terminology Trial Site Distribution Response Terminology Add new term to new codelist - - - Multicentre 2025-12-19 N/A Add C217004 Term Trial Site Distribution Response Terminology Trial Site Distribution Response Terminology Add new term to new codelist - - - Single-Centre 2025-12-19 N/A Add C217050 Term Trial Site Geographic Scope Response Terminology Trial Site Geographic Scope Response Terminology Add new codelist - - - Trial Site Geographic Scope Response Terminology 2025-12-19 N/A Add C217007 Term Trial Site Geographic Scope Response Terminology Trial Site Geographic Scope Response Terminology Add new term to new codelist - - - Multiple Countries 2025-12-19 N/A Add C217006 Term Trial Site Geographic Scope Response Terminology Trial Site Geographic Scope Response Terminology Add new term to new codelist - - - Single Country 2025-12-19 N/A Add C217287 Term Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology Add new codelist - - - Trial-Related Safety Event Type Response Terminology 2025-12-19 N/A Add C41331 Term Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology Add new term to new codelist - - - Adverse Event 2025-12-19 N/A Add C222331 Term Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology Add new term to new codelist - - - Drug/Device Combination Product Complaint 2025-12-19 N/A Add C218510 Term Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology Add new term to new codelist - - - Lactation Event 2025-12-19 N/A Add C218513 Term Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology Add new term to new codelist - - - Not Reportable Adverse Event of Special Interest 2025-12-19 N/A Add C17649 Term Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology Add new term to new codelist - - - Other 2025-12-19 N/A Add C218511 Term Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology Add new term to new codelist - - - Post-Partum Event 2025-12-19 N/A Add C218509 Term Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology Add new term to new codelist - - - Pregnancy Event 2025-12-19 N/A Add C218512 Term Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology Add new term to new codelist - - - Reportable Adverse Event of Special Interest 2025-12-19 N/A Add C41335 Term Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology Add new term to new codelist - - - Serious Adverse Event 2025-12-19 N/A Add C218508 Term Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology Add new term to new codelist - - - Trial Intervention Complaint 2025-12-19 N/A Add C217048 Term Unit of Measure Terminology Unit of Measure Terminology Add new codelist - - - Unit of Measure Terminology 2025-12-19 N/A Add C25301 Term Unit of Measure Terminology Unit of Measure Terminology Add new term to new codelist - - - Days 2025-12-19 N/A Add C25529 Term Unit of Measure Terminology Unit of Measure Terminology Add new term to new codelist - - - Hours 2025-12-19 N/A Add C29846 Term Unit of Measure Terminology Unit of Measure Terminology Add new term to new codelist - - - Months 2025-12-19 N/A Add C29844 Term Unit of Measure Terminology Unit of Measure Terminology Add new term to new codelist - - - Weeks 2025-12-19 N/A Add C29848 Term Unit of Measure Terminology Unit of Measure Terminology Add new term to new codelist - - - Years