ICH M11 Terminology

Preferred Label : ICH M11 Terminology;

NCIt related terms : M11;

Alternative definition : ICH: The terminology subset that includes terms pertaining to the ICH M11 protocol template.;

Details

Origin ID

C217023;

concept_is_in_subset
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Terminology [NCIt concept]
subset_includes_concept
- Access to Trial Intervention after End of Trial [NCIt concept]
- Active Comparator Arm [NCIt concept]
- Active Control [NCIt concept]
- Adaptive Trial Design Indicator [NCIt concept]
- Additional Description of Duration [NCIt concept]
- Additional Description of Trial Design [NCIt concept]
- Additional Required Medicinal Product [NCIt concept]
- Adjudication Committee [NCIt concept]
- Adverse Event [NCIt concept]
- Adverse Event of Special Interest [NCIt concept]
- Age Unit [NCIt concept]
- Alternate Description of Planned Duration of Trial Intervention [NCIt concept]
- Alternate Description of Planned Duration of Trial Participation [NCIt concept]
- Alternative Location of Protocol Changes [NCIt concept]
- Amendment Identifier [NCIt concept]
- Amendment Impacts Participant's Safety or Rights Indicator [NCIt concept]
- Amendment Impacts Reliability and Robustness of Data Indicator [NCIt concept]
- Amendment Scope Enrollment Description [NCIt concept]
- Amendment Scope Global Applicability Indicator [NCIt concept]
- Approximate Participant Enrollment At Time of Sponsor Approval [NCIt concept]
- Arm Name [NCIt concept]
- Auxiliary Medicinal Product [NCIt concept]
- Background Treatment [NCIt concept]
- Baseline Assessments and Procedures Description [NCIt concept]
- Behavioral Intervention [NCIt concept]
- Biological Agent [NCIt concept]
- Blinding Role [NCIt concept]
- Brief Explanation of Substantial Impact on Participant Safety [NCIt concept]
- Brief Explanation of Substantial Impact on Study Data [NCIt concept]
- Brief Rationale for Protocol Change [NCIt concept]
- By Cohort [NCIt concept]
- Caregiver [NCIt concept]
- Causality [NCIt concept]
- Centrally Sourced Indicator [NCIt concept]
- Challenge Agent [NCIt concept]
- Change in Standard Of Care Amendment Reason [NCIt concept]
- Change in Strategy Amendment Reason [NCIt concept]
- Clinical Laboratory Assessment [NCIt concept]
- Clinical Study Sponsor [NCIt concept]
- Clinical Trial Investigational Product Handling Instruction Documentation [NCIt concept]
- Clinical Trial Source Data Documentation [NCIt concept]
- Clinicaltrials.gov Identifier [NCIt concept]
- Co-Sponsor Legal Address [NCIt concept]
- Co-Sponsor Name [NCIt concept]
- Combination Product [NCIt concept]
- Committee Description [NCIt concept]
- Concomitant Therapy [NCIt concept]
- Control Arm [NCIt concept]
- Control Type [NCIt concept]
- Country Code [NCIt concept]
- Country and/or Region Identifier [NCIt concept]
- Country and/or Region-Specific Protocol Clarifications Description [NCIt concept]
- Country and/or Region-Specific Trial Requirements [NCIt concept]
- Criteria for Early Trial Site Closure [NCIt concept]
- Crossover Study [NCIt concept]
- Cumulative Dose [NCIt concept]
- Data Governance [NCIt concept]
- Data Protection [NCIt concept]
- Day [NCIt concept]
- Decision Rights for Trial Site Closure [NCIt concept]
- Definition of Adverse Events [NCIt concept]
- Definition of Medical Device Product Complaints [NCIt concept]
- Definition of Product Complaints [NCIt concept]
- Definition of Serious Adverse Events [NCIt concept]
- Definitions Related to Trial Participant Childbearing Potential [NCIt concept]
- Description of Assent Process [NCIt concept]
- Description of Emergency Consent Process [NCIt concept]
- Description of Investigational Trial Intervention [NCIt concept]
- Description of Level and Method of Blinding [NCIt concept]
- Description of Noninvestigational Trial Intervention [NCIt concept]
- Description of Protocol Change [NCIt concept]
- Description of Trial Baseline Variable Analysis [NCIt concept]
- Description of Trial Duration [NCIt concept]
- Description of Trial Population and Rationale [NCIt concept]
- Description of the Participants Included in Data Analysis [NCIt concept]
- Designated Medical Expert Contact Information or Location of Contact Information [NCIt concept]
- Device Manufacturer Legal Address [NCIt concept]
- Device Manufacturer Name [NCIt concept]
- Device Problem [NCIt concept]
- Diagnostic Procedure [NCIt concept]
- Dietary Supplement [NCIt concept]
- Different Dose or Regimen Control [NCIt concept]
- Disease-related Events or Outcomes Not Qualifying as Adverse Events or Serious Adverse Events [NCIt concept]
- Document Version Date [NCIt concept]
- Dose Escalation Committee [NCIt concept]
- Dose Response Control [NCIt concept]
- Dose Strength [NCIt concept]
- Double Blind Study [NCIt concept]
- Drug/Device Combination Product Indicator [NCIt concept]
- EU Clinical Trial Register Number [NCIt concept]
- Efficacy Assessments and Procedures Description [NCIt concept]
- Electrocardiogram [NCIt concept]
- Emergency Unblinding at the Site [NCIt concept]
- End Point [NCIt concept]
- End of Trial Explanation [NCIt concept]
- Event Collection and Reporting Timing Description [NCIt concept]
- Event Follow-up Procedure Description [NCIt concept]
- Event Recording Procedure Description [NCIt concept]
- Event Reporting Procedure Description [NCIt concept]
- Exclusion Criteria [NCIt concept]
- Exploratory Objective Statistical Analysis Method [NCIt concept]
- External Control [NCIt concept]
- Factorial Study [NCIt concept]
- First Protocol Amendment [NCIt concept]
- Gene Therapy [NCIt concept]
- General Statistical Consideration [NCIt concept]
- Generic Name [NCIt concept]
- Genetics and Pharmacogenomics Assessment [NCIt concept]
- Global [NCIt concept]
- Glossary of Terms and Abbreviations [NCIt concept]
- Group Sequential Design [NCIt concept]
- Handling of Data in Relation to Primary Estimand(s) [NCIt concept]
- Handling of Data in Relation to Secondary Estimand(s) [NCIt concept]
- Handling of Missing Data in Relation to Primary Estimand(s) [NCIt concept]
- Handling of Missing Data in Relation to Secondary Estimand(s) [NCIt concept]
- Healthcare Utilization [NCIt concept]
- Hour [NCIt concept]
- ICH M11 Amendment Details Statement Value Set Terminology [NCIt concept]
- ICH M11 Amendment Scope Enrollment Description Value Set Terminology [NCIt concept]
- ICH M11 Amendment Scope Value Set Terminology [NCIt concept]
- ICH M11 Control Type Value Set Terminology [NCIt concept]
- ICH M11 Independent Committee Name Value Set Terminology [NCIt concept]
- ICH M11 Intervention Model Value Set Terminology [NCIt concept]
- ICH M11 Intervention Type Value Set Terminology [NCIt concept]
- ICH M11 Intervention Use Value Set Terminology [NCIt concept]
- ICH M11 Investigational Medicinal Product Indicator Value Set Terminology [NCIt concept]
- ICH M11 No Yes Value Set Terminology [NCIt concept]
- ICH M11 Population Type Value Set Terminology [NCIt concept]
- ICH M11 Protocol Section 1 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 1 PROTOCOL SUMMARY [NCIt concept]
- ICH M11 Protocol Section 1.1 Protocol Synopsis [NCIt concept]
- ICH M11 Protocol Section 1.1.1 Primary and Secondary Objectives and Estimands [NCIt concept]
- ICH M11 Protocol Section 1.1.2 Overall Design [NCIt concept]
- ICH M11 Protocol Section 1.2 Trial Schema [NCIt concept]
- ICH M11 Protocol Section 1.3 Schedule of Activities [NCIt concept]
- ICH M11 Protocol Section 10 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS [NCIt concept]
- ICH M11 Protocol Section 10.1 General Considerations [NCIt concept]
- ICH M11 Protocol Section 10.10 Multiplicity Adjustments [NCIt concept]
- ICH M11 Protocol Section 10.11 Sample Size Determination [NCIt concept]
- ICH M11 Protocol Section 10.2 Analysis Sets [NCIt concept]
- ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables [NCIt concept]
- ICH M11 Protocol Section 10.4 Analyses Associated with the Primary Objective(s) [NCIt concept]
- ICH M11 Protocol Section 10.4.1 Primary Objective [NCIt concept]
- ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method [NCIt concept]
- ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s) [NCIt concept]
- ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s) [NCIt concept]
- ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis [NCIt concept]
- ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis [NCIt concept]
- ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s) [NCIt concept]
- ICH M11 Protocol Section 10.5.1 Secondary Objective [NCIt concept]
- ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method [NCIt concept]
- ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s) [NCIt concept]
- ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s) [NCIt concept]
- ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis [NCIt concept]
- ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis [NCIt concept]
- ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s) [NCIt concept]
- ICH M11 Protocol Section 10.7 Safety Analyses [NCIt concept]
- ICH M11 Protocol Section 10.8 Other Analyses [NCIt concept]
- ICH M11 Protocol Section 10.9 Interim Analyses [NCIt concept]
- ICH M11 Protocol Section 11 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS [NCIt concept]
- ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations [NCIt concept]
- ICH M11 Protocol Section 11.10 Protocol Deviations [NCIt concept]
- ICH M11 Protocol Section 11.11 Early Site Closure [NCIt concept]
- ICH M11 Protocol Section 11.12 Data Dissemination [NCIt concept]
- ICH M11 Protocol Section 11.2 Trial Oversight [NCIt concept]
- ICH M11 Protocol Section 11.2.1 Investigator Responsibilities [NCIt concept]
- ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities [NCIt concept]
- ICH M11 Protocol Section 11.3 Informed Consent Process [NCIt concept]
- ICH M11 Protocol Section 11.3.1 Informed Consent for Rescreening [NCIt concept]
- ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research [NCIt concept]
- ICH M11 Protocol Section 11.4 Committees [NCIt concept]
- ICH M11 Protocol Section 11.5 Insurance and Indemnity [NCIt concept]
- ICH M11 Protocol Section 11.6 Risk-Based Quality Management [NCIt concept]
- ICH M11 Protocol Section 11.7 Data Governance [NCIt concept]
- ICH M11 Protocol Section 11.8 Data Protection [NCIt concept]
- ICH M11 Protocol Section 11.9 Source Data [NCIt concept]
- ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS [NCIt concept]
- ICH M11 Protocol Section 12 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 12.1 Clinical Laboratory Tests [NCIt concept]
- ICH M11 Protocol Section 12.2 Country/Region-Specific Differences [NCIt concept]
- ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s) [NCIt concept]
- ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS [NCIt concept]
- ICH M11 Protocol Section 13 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 14 APPENDIX: REFERENCES [NCIt concept]
- ICH M11 Protocol Section 14 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 2 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 2 INTRODUCTION [NCIt concept]
- ICH M11 Protocol Section 2.1 Purpose of Trial [NCIt concept]
- ICH M11 Protocol Section 2.2 Assessment of Risks and Benefits [NCIt concept]
- ICH M11 Protocol Section 2.2.1 Risk Summary and Mitigation Strategy [NCIt concept]
- ICH M11 Protocol Section 2.2.2 Benefit Summary [NCIt concept]
- ICH M11 Protocol Section 2.2.3 Overall Risk-Benefit Assessment [NCIt concept]
- ICH M11 Protocol Section 3 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS [NCIt concept]
- ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s) [NCIt concept]
- ICH M11 Protocol Section 3.1.1 Primary Objective [NCIt concept]
- ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s) [NCIt concept]
- ICH M11 Protocol Section 3.2.1 Secondary Objective [NCIt concept]
- ICH M11 Protocol Section 3.3 Exploratory Objective(s) [NCIt concept]
- ICH M11 Protocol Section 3.3.1 Exploratory Objective [NCIt concept]
- ICH M11 Protocol Section 4 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 4 TRIAL DESIGN [NCIt concept]
- ICH M11 Protocol Section 4.1 Description of Trial Design [NCIt concept]
- ICH M11 Protocol Section 4.1.1 Stakeholder Input into Design [NCIt concept]
- ICH M11 Protocol Section 4.2 Rationale for Trial Design [NCIt concept]
- ICH M11 Protocol Section 4.2.1 Rationale for Estimand(s) [NCIt concept]
- ICH M11 Protocol Section 4.2.2 Rationale for Intervention Model [NCIt concept]
- ICH M11 Protocol Section 4.2.3 Rationale for Control Type [NCIt concept]
- ICH M11 Protocol Section 4.2.4 Rationale for Trial Duration [NCIt concept]
- ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial Design [NCIt concept]
- ICH M11 Protocol Section 4.2.6 Rationale for Interim Analysis [NCIt concept]
- ICH M11 Protocol Section 4.2.7 Rationale for Other Trial Design Aspects [NCIt concept]
- ICH M11 Protocol Section 4.3 Trial Stopping Rules [NCIt concept]
- ICH M11 Protocol Section 4.4 Start of Trial and End of Trial [NCIt concept]
- ICH M11 Protocol Section 4.5 Access to Trial Intervention After End of Trial [NCIt concept]
- ICH M11 Protocol Section 5 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 5 TRIAL POPULATION [NCIt concept]
- ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale [NCIt concept]
- ICH M11 Protocol Section 5.2 Inclusion Criteria [NCIt concept]
- ICH M11 Protocol Section 5.3 Exclusion Criteria [NCIt concept]
- ICH M11 Protocol Section 5.4 Contraception [NCIt concept]
- ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential [NCIt concept]
- ICH M11 Protocol Section 5.4.2 Contraception Requirements [NCIt concept]
- ICH M11 Protocol Section 5.5 Lifestyle Restrictions [NCIt concept]
- ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions [NCIt concept]
- ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions [NCIt concept]
- ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions [NCIt concept]
- ICH M11 Protocol Section 5.5.4 Other Activity Restrictions [NCIt concept]
- ICH M11 Protocol Section 5.6 Screen Failure and Rescreening [NCIt concept]
- ICH M11 Protocol Section 6 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY [NCIt concept]
- ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention [NCIt concept]
- ICH M11 Protocol Section 6.10 Concomitant Therapy [NCIt concept]
- ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy [NCIt concept]
- ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy [NCIt concept]
- ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen [NCIt concept]
- ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration [NCIt concept]
- ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification [NCIt concept]
- ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose [NCIt concept]
- ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention [NCIt concept]
- ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention [NCIt concept]
- ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention [NCIt concept]
- ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention [NCIt concept]
- ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding [NCIt concept]
- ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention [NCIt concept]
- ICH M11 Protocol Section 6.7.2 Randomisation [NCIt concept]
- ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding [NCIt concept]
- ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site [NCIt concept]
- ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence [NCIt concept]
- ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention [NCIt concept]
- ICH M11 Protocol Section 6.9.1 Background Trial Intervention [NCIt concept]
- ICH M11 Protocol Section 6.9.2 Rescue Therapy [NCIt concept]
- ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention [NCIt concept]
- ICH M11 Protocol Section 7 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL [NCIt concept]
- ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants [NCIt concept]
- ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention [NCIt concept]
- ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention [NCIt concept]
- ICH M11 Protocol Section 7.1.3 Rechallenge [NCIt concept]
- ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial [NCIt concept]
- ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up [NCIt concept]
- ICH M11 Protocol Section 8 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES [NCIt concept]
- ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations [NCIt concept]
- ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures [NCIt concept]
- ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures [NCIt concept]
- ICH M11 Protocol Section 8.4 Safety Assessments and Procedures [NCIt concept]
- ICH M11 Protocol Section 8.4.1 Physical Examination [NCIt concept]
- ICH M11 Protocol Section 8.4.2 Vital Signs [NCIt concept]
- ICH M11 Protocol Section 8.4.3 Electrocardiograms [NCIt concept]
- ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments [NCIt concept]
- ICH M11 Protocol Section 8.4.5 Pregnancy Testing [NCIt concept]
- ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring [NCIt concept]
- ICH M11 Protocol Section 8.5 Pharmacokinetics [NCIt concept]
- ICH M11 Protocol Section 8.6 Biomarkers [NCIt concept]
- ICH M11 Protocol Section 8.6.1 Genetics and Pharmacogenomics [NCIt concept]
- ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers [NCIt concept]
- ICH M11 Protocol Section 8.6.3 Other Biomarkers [NCIt concept]
- ICH M11 Protocol Section 8.7 Immunogenicity Assessments [NCIt concept]
- ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics [NCIt concept]
- ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS [NCIt concept]
- ICH M11 Protocol Section 9 Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section 9.1 Definitions [NCIt concept]
- ICH M11 Protocol Section 9.1.1 Definitions of Adverse Events [NCIt concept]
- ICH M11 Protocol Section 9.1.2 Definitions of Serious Adverse Events [NCIt concept]
- ICH M11 Protocol Section 9.1.3 Definitions of Product Complaints [NCIt concept]
- ICH M11 Protocol Section 9.1.3.1 Definition of Medical Device Product Complaints [NCIt concept]
- ICH M11 Protocol Section 9.2 Timing and Procedures for Collection and Reporting [NCIt concept]
- ICH M11 Protocol Section 9.2.1 Timing [NCIt concept]
- ICH M11 Protocol Section 9.2.2 Collection Procedures [NCIt concept]
- ICH M11 Protocol Section 9.2.3 Reporting [NCIt concept]
- ICH M11 Protocol Section 9.2.3.1 Regulatory Reporting Requirements [NCIt concept]
- ICH M11 Protocol Section 9.2.4 Adverse Events of Special Interest [NCIt concept]
- ICH M11 Protocol Section 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs [NCIt concept]
- ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information [NCIt concept]
- ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the Trial [NCIt concept]
- ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the Trial [NCIt concept]
- ICH M11 Protocol Section 9.4 Special Safety Situations [NCIt concept]
- ICH M11 Protocol Section Amendment Details Data Element Terminology [NCIt concept]
- ICH M11 Protocol Section Name and Number Value Set Terminology [NCIt concept]
- ICH M11 Protocol Section Title Page Data Element Terminology [NCIt concept]
- ICH M11 Reason for Amendment Value Set Terminology [NCIt concept]
- ICH M11 Sourcing Value Set Terminology [NCIt concept]
- ICH M11 Sponsor Approval Date Value Set Terminology [NCIt concept]
- ICH M11 Trial Arm Type Value Set Terminology [NCIt concept]
- ICH M11 Trial Blind Schema Value Set Terminology [NCIt concept]
- ICH M11 Trial Blinding Role Value Set Terminology [NCIt concept]
- ICH M11 Trial Intervention Assignment Method Value Set Terminology [NCIt concept]
- ICH M11 Trial Phase Value Set Terminology [NCIt concept]
- ICH M11 Trial Site Distribution Value Set Terminology [NCIt concept]
- ICH M11 Trial Site Geographic Scope Value Set Terminology [NCIt concept]
- ICH M11 Trial-Related Safety Event Type Value Set Terminology [NCIt concept]
- ICH M11 Units of Measure Value Set Terminology [NCIt concept]
- IMP Addition Amendment Reason [NCIt concept]
- IMP or NIMP Indicator [NCIt concept]
- IRB/IEC Feedback Amendment Reason [NCIt concept]
- Immunogenicity Assessment [NCIt concept]
- Inclusion Criteria [NCIt concept]
- Inconsistency and/or Error in the Protocol Amendment Reason [NCIt concept]
- Independent Data Monitoring Committee [NCIt concept]
- Independent Oversight Committee [NCIt concept]
- Informed Consent Process [NCIt concept]
- Informed Consent Requirements for Rescreening [NCIt concept]
- Informed Consent Requirements for Use of Remaining Samples in Exploratory Research [NCIt concept]
- Insurance and Indemnity Summary [NCIt concept]
- Intercurrent Event Description [NCIt concept]
- Intercurrent Event Strategy [NCIt concept]
- Interim Analysis [NCIt concept]
- International Nonproprietary Name [NCIt concept]
- Intervention Assignment Method [NCIt concept]
- Intervention Model [NCIt concept]
- Intervention Name [NCIt concept]
- Intervention Type [NCIt concept]
- Interventional Study Design Rationale [NCIt concept]
- Investigational Arm [NCIt concept]
- Investigational Intervention Sourcing Indicator [NCIt concept]
- Investigational Medicinal Product [NCIt concept]
- Investigational Trial Intervention Adherence Measures Description [NCIt concept]
- Investigational Trial Intervention Administration [NCIt concept]
- Investigational Trial Intervention Dose Modification [NCIt concept]
- Investigator [NCIt concept]
- Investigator Expectations for Source Data [NCIt concept]
- Investigator Responsibilities [NCIt concept]
- Investigator/Site Feedback Amendment Reason [NCIt concept]
- Japan Registry for Clinical Trials Number [NCIt concept]
- Laboratory Procedure [NCIt concept]
- Lactation Event [NCIt concept]
- Local Sponsor Legal Address [NCIt concept]
- Local Sponsor Name [NCIt concept]
- Locally [NCIt concept]
- Locally Sourced Indicator [NCIt concept]
- Location of Sponsor Approval Date [NCIt concept]
- Management of Investigational Trial Intervention Overdose [NCIt concept]
- Management of Loss to Follow-Up [NCIt concept]
- Manufacturing Change Amendment Reason [NCIt concept]
- Master Protocol Indicator [NCIt concept]
- Medical Device [NCIt concept]
- Month [NCIt concept]
- Multicenter Study [NCIt concept]
- Multiple Countries [NCIt concept]
- Multiplicity Adjustments [NCIt concept]
- NMPA IND Number [NCIt concept]
- New Data Available (Other Than Safety Data) Amendment Reason [NCIt concept]
- New Regulatory Guidance Amendment Reason [NCIt concept]
- New Safety Information Available Amendment Reason [NCIt concept]
- No Intervention Arm [NCIt concept]
- Non-Surgical Procedure [NCIt concept]
- None [NCIt concept]
- Not Applicable [NCIt concept]
- Not Applicable, Protocol Not Amended [NCIt concept]
- Not Global [NCIt concept]
- Not Reportable Adverse Event of Special Interest [NCIt concept]
- Number of Participants Randomly Assigned to Trial Intervention or Enrolled [NCIt concept]
- Observer Blind Study [NCIt concept]
- Official Protocol Title [NCIt concept]
- Open Label Study [NCIt concept]
- Original Protocol Indicator [NCIt concept]
- Other [NCIt concept]
- Other Activity Restrictions [NCIt concept]
- Other Analysis [NCIt concept]
- Other Biomarker Assessment [NCIt concept]
- Other Committee [NCIt concept]
- Other Noninvestigational Trial Intervention [NCIt concept]
- Other Regulatory or Clinical Trial Identifier [NCIt concept]
- Outcomes Assessor [NCIt concept]
- Overall Risk-Benefit Assessment Description [NCIt concept]
- Parallel Study [NCIt concept]
- Participant Assignment to Investigational Intervention Method [NCIt concept]
- Participants Who Become Pregnant During the Trial Data Collection [NCIt concept]
- Participants Whose Partners Become Pregnant During the Trial Data Collection [NCIt concept]
- Permitted Concomitant Therapy [NCIt concept]
- Pharmaceutical Dosage Form [NCIt concept]
- Pharmacodynamics Assessment [NCIt concept]
- Pharmacokinetic Assessment [NCIt concept]
- Pharmacologic Substance [NCIt concept]
- Phase 0 Trial [NCIt concept]
- Phase I Trial [NCIt concept]
- Phase I/II Trial [NCIt concept]
- Phase I/II/III Trial [NCIt concept]
- Phase I/III Trial [NCIt concept]
- Phase II Trial [NCIt concept]
- Phase II/III Trial [NCIt concept]
- Phase II/III/IV Trial [NCIt concept]
- Phase III Trial [NCIt concept]
- Phase III/IV Trial [NCIt concept]
- Phase IV Trial [NCIt concept]
- Physical Examination [NCIt concept]
- Placebo [NCIt concept]
- Placebo Control [NCIt concept]
- Placebo Control Arm [NCIt concept]
- Planned Duration of Trial Intervention [NCIt concept]
- Planned Duration of Trial Intervention Unit of Time [NCIt concept]
- Planned Duration of Trial Participation [NCIt concept]
- Planned Duration of Trial Participation Unit of Time [NCIt concept]
- Planned Maximum Age of Subjects [NCIt concept]
- Planned Minimum Age of Subjects [NCIt concept]
- Planned Number of Arms [NCIt concept]
- Planned Subject Number [NCIt concept]
- Population Type [NCIt concept]
- Population-Level Summary [NCIt concept]
- Post-Partum Event [NCIt concept]
- Pregnancy Event [NCIt concept]
- Pregnancy Test [NCIt concept]
- Primary Reason for Protocol Amendment [NCIt concept]
- Primary and Secondary Objectives and Estimands Summary [NCIt concept]
- Prior Protocol Amendment Indicator [NCIt concept]
- Prohibited Concomitant Therapy [NCIt concept]
- Proprietary Name [NCIt concept]
- Protocol Agent [NCIt concept]
- Protocol Amendment Details [NCIt concept]
- Protocol Approval Date or Location of Date [NCIt concept]
- Protocol Approval Method Description [NCIt concept]
- Protocol Approval by Sponsor Date [NCIt concept]
- Protocol Change Section Number and Name [NCIt concept]
- Protocol Confidentiality Statement [NCIt concept]
- Protocol Design Error Amendment Reason [NCIt concept]
- Protocol Deviation Management [NCIt concept]
- Protocol Previously Amended See Summary of Changes Before the Table of Contents [NCIt concept]
- Protocol Previously Amended, Details Presented [NCIt concept]
- Radiation Therapy [NCIt concept]
- Randomization [NCIt concept]
- Rationale for Adaptive or Novel Trial Design [NCIt concept]
- Rationale for Interim Analysis [NCIt concept]
- Rationale for Investigational Trial Intervention Dose and Regimen [NCIt concept]
- Rationale for Other Trial Design Aspects [NCIt concept]
- Rationale for Trial Control Type [NCIt concept]
- Rationale for Trial Duration [NCIt concept]
- Rationale for Trial Estimand [NCIt concept]
- Rechallenge Requirement [NCIt concept]
- Recruitment Difficulty Amendment Reason [NCIt concept]
- Reference List [NCIt concept]
- Region Identifier [NCIt concept]
- Regulatory Agency Request to Amend Amendment Reason [NCIt concept]
- Regulatory Reporting Requirements for Trial-Related Events [NCIt concept]
- Reportable Adverse Event of Special Interest [NCIt concept]
- Reportable Period End Date [NCIt concept]
- Reportable Period Start Date [NCIt concept]
- Requirements for Permanent Discontinuation of Trial Intervention [NCIt concept]
- Requirements for Temporary Discontinuation of Trial Intervention [NCIt concept]
- Rescreening [NCIt concept]
- Rescue Medications [NCIt concept]
- Rescue Therapy [NCIt concept]
- Responsibilities Following Early Trial Site Closure [NCIt concept]
- Risk-Based Quality Management [NCIt concept]
- Route of Administration [NCIt concept]
- Safety Analysis [NCIt concept]
- Safety Assessments and Procedures Description [NCIt concept]
- Safety Event Situational Scope Description [NCIt concept]
- Sample Size Calculation [NCIt concept]
- Schedule of Activities [NCIt concept]
- Screening Assessments and Procedures Description [NCIt concept]
- Secondary Reason for Protocol Amendment [NCIt concept]
- Serious Adverse Event [NCIt concept]
- Severity [NCIt concept]
- Sham Comparator Arm [NCIt concept]
- Sham Control [NCIt concept]
- Single Blind Study [NCIt concept]
- Single Country [NCIt concept]
- Single Group Study [NCIt concept]
- Single-Center Study [NCIt concept]
- Site Distribution Indicator [NCIt concept]
- Site Geographic Scope Indicator [NCIt concept]
- Special Safety Situation Type [NCIt concept]
- Sponsor Legal Address [NCIt concept]
- Sponsor Protocol Identifier [NCIt concept]
- Sponsor Responsibilities [NCIt concept]
- Sponsor's Investigational Product Code [NCIt concept]
- Stakeholder Input into Trial Design [NCIt concept]
- Start of Trial Explanation [NCIt concept]
- Stopping Rules [NCIt concept]
- Stratification [NCIt concept]
- Stratified Randomization [NCIt concept]
- Study Arm Type [NCIt concept]
- Study Blinding Procedure [NCIt concept]
- Study Data Dissemination [NCIt concept]
- Study Design Description [NCIt concept]
- Study Design Rationale [NCIt concept]
- Study Participant [NCIt concept]
- Study Population [NCIt concept]
- Study Product Accountability [NCIt concept]
- Study Product Preparation [NCIt concept]
- Study Protocol Version Acronym [NCIt concept]
- Study Protocol Version Number [NCIt concept]
- Study Purpose [NCIt concept]
- Study Schematic [NCIt concept]
- Study Site Identifier [NCIt concept]
- Study Subject Discontinuation Rationale [NCIt concept]
- Suicidal Ideation and Behaviour Risk Monitoring [NCIt concept]
- Summary [NCIt concept]
- Surgical Procedure [NCIt concept]
- Therapeutic Procedure [NCIt concept]
- Timing Description for Reporting to Sponsor or Designee [NCIt concept]
- Treatment Effect Sensitivity Analysis [NCIt concept]
- Treatment Effect Supplementary Analysis [NCIt concept]
- Treatment Regimen [NCIt concept]
- Trial Assessments and Procedures Considerations Description [NCIt concept]
- Trial Blinding Schema [NCIt concept]
- Trial Event Back-Up Reporting Method [NCIt concept]
- Trial Event Reporting Method [NCIt concept]
- Trial Exploratory Objective [NCIt concept]
- Trial Indication [NCIt concept]
- Trial Intervention Complaint [NCIt concept]
- Trial Intervention Intent [NCIt concept]
- Trial Intervention Overview or Informational Table Header [NCIt concept]
- Trial Monitor Expectations for Source Data [NCIt concept]
- Trial Oversight Procedure Description [NCIt concept]
- Trial Participant Benefit Summary [NCIt concept]
- Trial Participant Caffeine, Alcohol, Tobacco, and Other Substance Restrictions [NCIt concept]
- Trial Participant Contraception Requirements [NCIt concept]
- Trial Participant Lifestyle Restrictions [NCIt concept]
- Trial Participant Meals and Dietary Restrictions [NCIt concept]
- Trial Participant Physical Activity Restrictions [NCIt concept]
- Trial Participation Number Target or Maximum Indicator [NCIt concept]
- Trial Phase [NCIt concept]
- Trial Primary Objective [NCIt concept]
- Trial Regulatory and Ethical Consideration [NCIt concept]
- Trial Schematic Note [NCIt concept]
- Trial Screen Failure [NCIt concept]
- Trial Secondary Objective [NCIt concept]
- Trial Short Title [NCIt concept]
- Trial-Related Event Identification [NCIt concept]
- Trial-Related Safety Event Type [NCIt concept]
- Trial-Related Source Data Description [NCIt concept]
- Trial-Related Statistical Analysis Method [NCIt concept]
- Trial-specific Intervention Risks and Mitigation Strategy Description [NCIt concept]
- Trial-specific Other Risks and Mitigation Strategy Description [NCIt concept]
- Trial-specific Procedure Risks and Mitigation Strategy Description [NCIt concept]
- US FDA Investigational Device Exemption Application Number [NCIt concept]
- US FDA Investigational New Drug Application Number [NCIt concept]
- Uncontrolled Study [NCIt concept]
- Vaccine [NCIt concept]
- Vital Signs [NCIt concept]
- WHO/UTN Number [NCIt concept]
- Week [NCIt concept]
- With Disease [NCIt concept]
- Without Disease [NCIt concept]
- Year [NCIt concept]
- Yes [NCIt concept]

Keyword's position in hierarchy(ies) :

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