ICH M11 Controlled Terminology

ICH M11 Controlled Terminology, 2025-12-19

C217274	Amendment Details Statement Response Terminology
C217275	Amendment Scope Enrollment Description Response Terminology
C217047	Amendment Scope Response Terminology
C217279	Control Type Response Terminology
C217342	ICH M11 Section 1 Terminology
C217351	ICH M11 Section 10 Terminology
C217352	ICH M11 Section 11 Terminology
C217353	ICH M11 Section 12 Terminology
C217354	ICH M11 Section 13 Terminology
C217355	ICH M11 Section 14 Terminology
C217343	ICH M11 Section 2 Terminology
C217344	ICH M11 Section 3 Terminology
C217345	ICH M11 Section 4 Terminology
C217346	ICH M11 Section 5 Terminology
C217347	ICH M11 Section 6 Terminology
C217348	ICH M11 Section 7 Terminology
C217349	ICH M11 Section 8 Terminology
C217350	ICH M11 Section 9 Terminology
C217357	ICH M11 Section Amendment Details Terminology
C217356	ICH M11 Section Title Page Terminology
C217282	Independent Committee Name Response Terminology
C217277	Intervention Model Response Terminology
C217284	Intervention Type Response Terminology
C217285	Intervention Use Response Terminology
C217052	Investigational Intervention Sourcing Response Terminology
C217286	Investigational Medicinal Product Indicator Response Terminology
C217046	No Yes Response Terminology
C217278	Population Type Response Terminology
C217272	Protocol Section Name and Number Response Terminology
C217276	Reason for Amendment Response Terminology
C217283	Trial Arm Type Response Terminology
C217281	Trial Blinding Role Response Terminology
C217051	Trial Blinding Schema Response Terminology
C217280	Trial Intervention Assignment Method Response Terminology
C217045	Trial Phase Response Terminology
C217049	Trial Site Distribution Response Terminology
C217050	Trial Site Geographic Scope Response Terminology
C217287	Trial-Related Safety Event Type Response Terminology
C217048	Unit of Measure Terminology

Codelist Definitions

OID	Name (ICH Preferred Term)	DataType Extensible	NCI Code	ICH Synonym	ICH Definition	Preferred Term
	ICH Preferred Term [ODM:CodedValue]
CL.C217274.Amendment Details Statement Response Terminology	Amendment Details Statement Response Terminology (Amendment Details Statement Response Terminology)	text Extensible: No	C217274	Amendment Details Statement Response Terminology	A valid value set relevant to the amendment details statement responses within the ICH M11 protocol template.	ICH M11 Amendment Details Statement Value Set Terminology
	This is the first protocol amendment.		C218486		This is the first protocol amendment.	First Protocol Amendment
	This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s).		C218487		This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s).	Protocol Previously Amended, Details Presented
	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.		C218488		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.	Protocol Previously Amended See Summary of Changes Before the Table of Contents
	This protocol has not been amended.		C218485		This protocol has not been amended.	Protocol Not Amended
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CL.C217275.Amendment Scope Enrollment Description Response Terminology	Amendment Scope Enrollment Description Response Terminology (Amendment Scope Enrollment Description Response Terminology)	text Extensible: No	C217275	Amendment Scope Enrollment Description Response Terminology	A valid value set relevant to the amendment scope enrollment description responses within the ICH M11 protocol template.	ICH M11 Amendment Scope Enrollment Description Value Set Terminology
	By Cohort		C218489		Covering or affecting a cohort of individuals.	By Cohort
	Globally		C68846		Covering or affecting the whole of a system.	Global
	Locally		C41065		Covering or affecting a portion of the system.	Locally
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CL.C217047.Amendment Scope Response Terminology	Amendment Scope Response Terminology (Amendment Scope Response Terminology)	text Extensible: No	C217047	Amendment Scope Response Terminology	Terminology associated with the amendment scope value set codelist of the ICH M11 protocol template.	ICH M11 Amendment Scope Value Set Terminology
	Global		C68846		Covering or affecting the whole of a system.	Global
	Not Global		C217026		Covering or affecting a portion of the system.	Not Global
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CL.C217279.Control Type Response Terminology	Control Type Response Terminology (Control Type Response Terminology)	text Extensible: No	C217279	Control Type Response Terminology	A valid value set relevant to the control type responses within the ICH M11 protocol template.	ICH M11 Control Type Value Set Terminology
	Active Comparator		C49649		A type of control, which has a demonstrated effect, administered as a comparator to participants in a clinical trial.	Active Control
	Different Dose or Regimen		C218505		A type of control that comprises a different dose or dosage regimen in comparison to the investigational intervention dose or dosage regimen.	Different Dose or Regimen Control
	Dose Response		C120841		A type of control using different doses or regimens of the same treatment across the treatment arms.	Dose Response Control
	External		C218506		The use of external control data as a control arm for those studies where ethical concerns and/or underserved disease indications may make it difficult to enroll participants.	External Control
	No Control		C28280		A clinical study that lacks a comparison (i.e., a control) group.	Uncontrolled Study
	Placebo		C49648		An inactive, identical-appearing drug or treatment that does not contain the test product.	Placebo Control
	Sham Procedure		C184727		A type of negative control in which a procedure is performed that mimics the procedure under study but does not include investigational processes or components.	Sham Control
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CL.C217342.ICH M11 Section 1 Terminology	ICH M11 Section 1 Terminology (ICH M11 Section 1 Terminology)	text Extensible: No	C217342	ICH M11 Section 1 Terminology	Terminology relevant to the data elements in section 1 of the ICH M11 protocol template.	ICH M11 Protocol Section 1 Data Element Terminology
	Adaptive Trial Design Indicator		C218706		An indication as to whether the clinical trial uses an adaptive trial design.	Adaptive Trial Design Indicator
	Additional Description of Duration		C218838		A narrative providing additional details about the duration of a participant's use of a trial intervention or their planned participation time in the trial.	Additional Description of Duration
	Alternate Description of Planned Duration of Trial Intervention		C218714		An alternative textual narrative for the planned duration of trial intervention.	Alternate Description of Planned Duration of Trial Intervention
	Alternate Description of Planned Duration of Trial Participation		C218717		An alternative narrative for the planned duration of trial participation.	Alternate Description of Planned Duration of Trial Participation
	Blinded Roles		C218709		An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function.	Blinding Role
	Control Type		C49647		A characterisation or classification of the comparator against which the study intervention is evaluated.	Control Type
	Drug/Device Combination Product Indicator		C218708		An indication as to whether the clinical trial is testing a drug-device combination product.	Drug/Device Combination Product Indicator
	Independent Committees		C218718		An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities.	Independent Oversight Committee
	INN		C142585		A unique name that is globally recognised and public property, which identifies pharmaceutical substances or active pharmaceutical ingredients.	International Nonproprietary Name
	Intervention Assignment Method		C218475		The technique used to assign trial participants to a trial intervention or trial arm.	Intervention Assignment Method
	Intervention Model		C98746		The overall design configuration for assigning intervention to participants.	Intervention Model
	Master Protocol Indicator		C218707		An indication as to whether the protocol is a master protocol.	Master Protocol Indicator
	Maximum Age		C49694		The anticipated maximum age of the participants to be entered in a clinical trial.	Planned Maximum Age of Subjects
	Minimum Age		C49693		The anticipated minimum age of the participants to be entered in a clinical trial.	Planned Minimum Age of Subjects
	Nonproprietary Name(s)		C97054		Drug name that is not protected by a trademark, usually descriptive of its chemical structure, and sometimes a public name.	Generic Name
	Number of Arms		C98771		The planned number of intervention groups.	Planned Number of Arms
	Number of Participants		C49692		The planned number of participants to be entered in a clinical trial.	Planned Subject Number
	Other Committees		C218719		A committee that is different than the one(s) previously specified or mentioned.	Other Committee
	Other Intervention Assignment Method		C223138		Description of any intervention assignment method that is different than the one(s) previously specified or mentioned.	Other Intervention Assignment Method
	Population Diagnosis or Condition		C112038		A description of the condition, disease or disorder that the clinical trial is intended to investigate or address.	Trial Indication
	Population Type		C218703		A characterisation or classification of the trial population.	Population Type
	Primary and Secondary Objectives and Estimands		C218839		A descriptive summary of the primary and secondary objectives and their associated estimands related to the trial.	Primary and Secondary Objectives and Estimands Summary
	Randomisation Type		C223137		A characterisation or classification of the randomisation used to assign trial participants to treatment or control groups.	Randomization Type
	randomly assigned to trial intervention/enrolled		C218711		The target or maximum number of participants who have been randomly assigned to the trial intervention or enrolled in the trial.	Number of Participants Randomly Assigned to Trial Intervention or Enrolled
	Schedule of Activities		C132349		A standardised representation of planned clinical trial activities including interventions (e.g., administering drug, surgery) and study administrative activities (e.g., obtaining informed consent, distributing clinical trial material and diaries, randomisation) as well as assessments.	Schedule of Activities
	Schema Notes		C218720		A brief written record describing the trial schematic.	Trial Schematic Note
	Site Distribution		C218704		An indication as to whether the occurrence applies to a single or multiple trial sites.	Site Distribution Indicator
	Site Geographic Scope		C218705		An indication as to whether the trial is taking place in one or more countries.	Site Geographic Scope Indicator
	Stratification Indicator		C223136		An indication as to whether stratification is used as part of the randomisation process.	Stratification Indicator
	Target/Maximum		C218710		A characterisation or classification of the trial participant numbers as to whether the numbers reflect a target or maximum.	Trial Participation Number Target or Maximum Indicator
	total planned duration of trial intervention unit of time		C218713		The unit of time associated with the numeric value for the planned duration of trial intervention.	Planned Duration of Trial Intervention Unit of Time
	total planned duration of trial intervention		C218712		The numeric value for the planned duration of trial intervention.	Planned Duration of Trial Intervention
	total planned duration of trial participation unit of time		C218716		The unit of time associated with the numeric value for the planned duration of trial participation.	Planned Duration of Trial Participation Unit of Time
	total planned duration of trial participation		C218715		The numeric value for the planned duration of trial participation.	Planned Duration of Trial Participation
	Trial Blind Schema		C49658		The type of experimental design used to describe the level of awareness of the trial participants and/ or personnel as it relates to the respective intervention(s) or assessments being observed, received or administered.	Trial Blinding Schema
	Trial Schema		C93682		A diagram that outlines the decision points (e.g. randomisation, response evaluation) that define the different paths a participant could take through the trial.	Study Schematic
	Units of Age		C50400		Those units of time that are routinely used to express the age of a person.	Age Unit
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CL.C217351.ICH M11 Section 10 Terminology	ICH M11 Section 10 Terminology (ICH M11 Section 10 Terminology)	text Extensible: No	C217351	ICH M11 Section 10 Terminology	Terminology relevant to the data elements in section 10 of the ICH M11 protocol template.	ICH M11 Protocol Section 10 Data Element Terminology
	Analyses Associated with the Exploratory Objective(s)		C218807		A description of the statistical model, hypothesis, and methods of analyses for each exploratory objective within the trial.	Exploratory Objective Statistical Analysis Method
	Analyses of Demographics and Other Baseline Variables		C218802		A description of analyses relevant to variables at baseline, for example demographics, related to the trial.	Description of Trial Baseline Variable Analysis
	Analysis Sets		C218801		A description of the set of participants whose data are to be included in the analyses.	Description of the Participants Included in Data Analysis
	General Considerations		C164387		Careful thought or deliberation related to the planned conduct of statistical analyses within the context of the trial.	General Statistical Consideration
	Handling of Data in Relation to Primary Estimand(s)		C218803		A description of how data will be handled for the statistical analysis in line with the primary estimand.	Handling of Data in Relation to Primary Estimand(s)
	Handling of Data in Relation to Secondary Estimand(s)		C218805		A description of how data will be handled for the statistical analysis in line with the secondary estimand.	Handling of Data in Relation to Secondary Estimand(s)
	Handling of Missing Data in Relation to Primary Estimand(s)		C218804		A description of how missing data associated with the primary estimand will be handled, including the rationale for the approach.	Handling of Missing Data in Relation to Primary Estimand(s)
	Handling of Missing Data in Relation to Secondary Estimand(s)		C218806		A description of how missing data associated with the secondary estimand will be handled, including the rationale for the approach.	Handling of Missing Data in Relation to Secondary Estimand(s)
	Interim Analyses		C142582		A description of any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial.	Interim Analysis
	Multiplicity Adjustments		C218810		A description of the statistical adjustments needed to limit the probability of false positive findings in trials where there are multiple simultaneous hypotheses.	Multiplicity Adjustments
	Other Analyses		C218809		A description of the analyses that are different than the one(s) previously specified or mentioned.	Other Analysis
	Safety Analyses		C218808		A description of the analyses of relevant safety variables, including adverse events of special interest.	Safety Analysis
	Sample Size Determination		C115467		A statistical calculation to determine the number of participants required for the primary analysis, which should be large enough to provide a reliable answer to the questions addressed and should be determined by the primary objective of the trial. If the sample size is determined on some other basis, then this should be made clear and justified.	Sample Size Calculation
	Sensitivity Analysis		C218480		A description of the series of analyses conducted to explore the robustness of inferences from the main estimator to deviations from its underlying modeling assumptions and limitations in the data.	Treatment Effect Sensitivity Analysis
	Statistical Analysis Method		C218482		A description of the statistical model, hypothesis, and methods of analyses for each objective within the trial.	Trial-Related Statistical Analysis Method
	Supplementary Analysis		C218481		A description of the analyses that are conducted in addition to the main and sensitivity analysis with the intent to provide additional insights into the understanding of the treatment effect.	Treatment Effect Supplementary Analysis
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CL.C217352.ICH M11 Section 11 Terminology	ICH M11 Section 11 Terminology (ICH M11 Section 11 Terminology)	text Extensible: No	C217352	ICH M11 Section 11 Terminology	Terminology relevant to the data elements in section 11 of the ICH M11 protocol template.	ICH M11 Protocol Section 11 Data Element Terminology
	Committees		C218819		A description of the type and administrative structure of any committee associated with the trial.	Committee Description
	Criteria for Early Closure		C218829		The requirements that must be met in order to close a trial site prematurely.	Criteria for Early Trial Site Closure
	Data Dissemination		C218831		A description of whether and which public databases the clinical trial, and results if applicable, will be registered.	Study Data Dissemination
	Data Governance		C218822		A description of the key processes to ensure data integrity, traceability and security, in order to enable accurate collection, reporting, monitoring, transfer, retention, access and publication.	Data Governance
	Data Protection		C218823		A description of the measures taken to protect the privacy and confidentiality of person information of trial participants in accordance with applicable regulatory requirements on personal data protection and any measures that should be taken in case of a data security breach.	Data Protection
	Decision Rights for Site Closure		C218828		A description of the legal principles of entitlement for the sponsor to close a trial site, or for the investigator to initiate the closure of a trial site.	Decision Rights for Trial Site Closure
	Description of Assent Process		C218815		A description of the assent process for those individuals unable to give informed consent on their own behalf, to participate in the trial.	Description of Assent Process
	Description of Emergency Consent Process		C218816		A type of informed consent process that may occur during an emergency situation in which the participant or their legally authorised representative is not available to give consent.	Description of Emergency Consent Process
	Description of Informed Consent Process		C184390		The procedure by which informed consent is obtained and documented by means of a written, signed, and dated informed consent form. This process may include obtaining assent from participants with legally authorised representatives.	Informed Consent Process
	Identification of Source Records		C222675		A description of how trial-related source records will be identified.	Identification of Source Records Description
	Informed Consent for Rescreening		C218817		A description of the consent requirements for participants in the event of screen failure and rescreening.	Informed Consent Requirements for Rescreening
	Informed Consent for Use of Remaining Samples in Exploratory Research		C218818		A description of the consent requirements for exploratory research using the remainder of mandatory samples. If applicable, this may include text in the original consent that address the use of remaining samples or additional text.	Informed Consent Requirements for Use of Remaining Samples in Exploratory Research
	Insurance and Indemnity		C218820		A concise summary of the arrangements for participants insurance and indemnity as required by the applicable regulatory body.	Insurance and Indemnity Summary
	Investigator Expectations for Source Records		C218825		A description of the obligations of the investigator with respect to maintaining and ensuring availability of the source records.	Investigator Expectations for Source Records
	Investigator Responsibilities		C218813		A description of the obligations of the investigator with respect to the trial.	Investigator Responsibilities
	Protocol Deviations		C218827		A description of plans for detecting, reviewing, and reporting any deviations from the protocol.	Protocol Deviation Management
	Regulatory and Ethical Considerations		C218811		Careful thought or deliberation related to the regulatory and ethical aspects of the trial.	Trial Regulatory and Ethical Consideration
	Responsibilities Following Early Site Closure		C218830		The responsibilities of the sponsor and/or investigator following an unplanned early termination or suspension of the trial at an individual site.	Responsibilities Following Early Trial Site Closure
	Risk-Based Quality Management		C218821		A description of how potential risks and critical to quality factors associated with the trial will be identified and handled.	Risk-Based Quality Management
	Source Records Introduction		C218824		A description of trial-related source records including the importance of source record maintenance and expectations for data traceability.	Trial-Related Source Records Description
	Sponsor Responsibilities		C218814		A description of the obligations of the sponsor with respect to the trial.	Sponsor Responsibilities
	Trial Monitor Expectations for Source Records		C218826		A description of the obligations of the trial monitor with respect to maintaining and ensuring availability of the source records.	Trial Monitor Expectations for Source Records
	Trial Oversight		C218812		A description of the planned processes and procedures to govern and conduct a clinical trial in order to protect the rights, safety and welfare of the trial participants.	Trial Oversight Procedure Description
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CL.C217353.ICH M11 Section 12 Terminology	ICH M11 Section 12 Terminology (ICH M11 Section 12 Terminology)	text Extensible: No	C217353	ICH M11 Section 12 Terminology	Terminology relevant to the data elements in section 12 of the ICH M11 protocol template.	ICH M11 Protocol Section 12 Data Element Terminology
	Additional Appendices		C220640		Extra or supplementary appendices added to the end of a document.	Additional Document Appendices
	Amendment Identifier		C218477		A sequence of characters used to uniquely identify a protocol amendment.	Amendment Identifier
	Amendment Scope Enrollment Description		C218695		The enrollment description as to whether the amendment scope applies globally, locally, or per cohort across the trial.	Amendment Scope Enrollment Description
	Approximately <#/%> enrolled		C218478		The value (expressed either numerically or as a percentage) for the estimated number of participants enrolled at the time of the protocol amendment.	Approximate Participant Enrollment At Time of Sponsor Approval
	Brief Rationale for Change		C181233		The brief reason for the change introduced in the current or prior version of the protocol.	Brief Rationale for Protocol Change
	Clinical Laboratory Tests		C25294		Any procedure that involves testing or manipulating a sample of blood, urine, or other body substance in a laboratory setting.	Laboratory Procedure
	Country/Region Identifier		C218832		A sequence of characters used to identify and/or name a country or region.	Country and/or Region Identifier
	Country/Region Specific Protocol Clarifications		C218834		A description of any country or region-specific clarifications related to a protocol item.	Country and/or Region-Specific Protocol Clarifications Description
	Country/Region-Specific Requirements		C218833		A description of any country or region-specific requirements related to the trial but not related to individual items in the protocol.	Country and/or Region-Specific Trial Requirements
	Description of Change		C218483		A description of the change introduced in the current or prior version of the protocol.	Description of Protocol Change
	Prior Protocol Amendment(s)		C218835		An indication as to whether the protocol has not been amended, is the first protocol amendment, or a statement that the protocol has been amended previously.	Prior Protocol Amendment Indicator
	Section # and Name		C218479		The protocol section number and name containing the change introduced in the current or prior version of the protocol.	Protocol Change Section Number and Name
	specify alternative location		C218836		The physical or virtual location of the overview of changes from each prior amendment.	Alternative Location of Protocol Changes
	Sponsor Approval Date		C132352		The date that the sponsor approved a version of the protocol.	Protocol Approval by Sponsor Date
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CL.C217354.ICH M11 Section 13 Terminology	ICH M11 Section 13 Terminology (ICH M11 Section 13 Terminology)	text Extensible: No	C217354	ICH M11 Section 13 Terminology	Terminology relevant to the data elements in section 13 of the ICH M11 protocol template.	ICH M11 Protocol Section 13 Data Element Terminology
	Glossary of Terms and Abbreviations		C218837		A list of terms with their abbreviations and/or definitions.	Glossary of Terms and Abbreviations
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CL.C217355.ICH M11 Section 14 Terminology	ICH M11 Section 14 Terminology (ICH M11 Section 14 Terminology)	text Extensible: No	C217355	ICH M11 Section 14 Terminology	Terminology relevant to the data elements in section 14 of the ICH M11 protocol template.	ICH M11 Protocol Section 14 Data Element Terminology
	References		C184397		The curated list of sources that are cited within the reference section of the document.	Reference List
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CL.C217343.ICH M11 Section 2 Terminology	ICH M11 Section 2 Terminology (ICH M11 Section 2 Terminology)	text Extensible: No	C217343	ICH M11 Section 2 Terminology	Terminology relevant to the data elements in section 2 of the ICH M11 protocol template.	ICH M11 Protocol Section 2 Data Element Terminology
	Benefit Summary		C218724		A short textual description containing the potential physical, psychological, social, legal, and other benefits to the trial participant.	Trial Participant Benefit Summary
	Overall Risk-Benefit Assessment		C218725		A short textual description containing the risks and benefits associated with participation in the trial.	Overall Risk-Benefit Assessment Description
	Purpose of Trial		C146997		The overall rationale, reason, or intention of the clinical trial.	Study Purpose
	Trial-specific Intervention Risks and Mitigations		C218721		A description of the potential risks associated with the trial interventions and mitigation strategies to be employed within the trial.	Trial-specific Intervention Risks and Mitigation Strategy Description
	Trial-specific Other Risks and Mitigations		C218723		A description of the potential risks associated with the trial procedures and mitigation strategies to be employed within the trial that are different than the one(s) previously specified or mentioned.	Trial-specific Other Risks and Mitigation Strategy Description
	Trial-specific Procedure Risks and Mitigations		C218722		A description of the potential risks associated with the trial procedures and mitigation strategies to be employed within the trial.	Trial-specific Procedure Risks and Mitigation Strategy Description
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CL.C217344.ICH M11 Section 3 Terminology	ICH M11 Section 3 Terminology (ICH M11 Section 3 Terminology)	text Extensible: No	C217344	ICH M11 Section 3 Terminology	Terminology relevant to the data elements in section 3 of the ICH M11 protocol template.	ICH M11 Protocol Section 3 Data Element Terminology
	Description of Intercurrent Event		C188856		A description of the intercurrent event.	Intercurrent Event Description
	Endpoint		C25212		The variable to be obtained for each patient that is required to address the clinical question. The specification of the variable might include whether the patient experiences an intercurrent event.	End Point
	Exploratory Objective		C163559		The exploratory reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study.	Trial Exploratory Objective
	Intercurrent Event Strategy		C188857		A description of the planned strategy to address intercurrent events.	Intercurrent Event Strategy
	Population		C70833		The population of patients targeted by the clinical question. This will be represented by the entire trial population, a subgroup defined by a particular characteristic measured at baseline, or a principal stratum defined by the occurrence (or non-occurrence, depending on context) of a specific intercurrent event.	Study Population
	Population-level Summary		C188853		Population level summary for the clinical endpoint of interest, which provides a basis for comparison between treatment conditions.	Population-Level Summary
	Primary Objective		C85826		The principle reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study.	Trial Primary Objective
	Secondary Objective		C85827		The secondary reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study.	Trial Secondary Objective
	Treatment		C49236		The treatment condition of interest and, as appropriate, the alternative treatment condition to which comparison will be made (referred to as "treatment" through the remainder of this document). These might be individual interventions, combinations of interventions administered concurrently, e.g. as add-on to standard of care, or might consist of an overall regimen involving a complex sequence of interventions.	Therapeutic Procedure
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CL.C217345.ICH M11 Section 4 Terminology	ICH M11 Section 4 Terminology (ICH M11 Section 4 Terminology)	text Extensible: No	C217345	ICH M11 Section 4 Terminology	Terminology relevant to the data elements in section 4 of the ICH M11 protocol template.	ICH M11 Protocol Section 4 Data Element Terminology
	Access to Trial Intervention After End of Trial		C218738		A narrative description containing information about whether and how trial participants have access to the trial interventions after the trial ends.	Access to Trial Intervention after End of Trial
	Additional Description of Trial Design		C218728		An extra or further textual description of the trial design.	Additional Description of Trial Design
	Description of Level and Method of Blinding		C218727		A description of the level of awareness of the study participants and/or personnel to the respective intervention(s) or assessments being observed, received or administered, and the methodology by which study participants or personnel are blinded.	Description of Level and Method of Blinding
	Description of Method of Assignment to Trial Intervention		C219658		A description of the methodology used to assign trial participants to a trial intervention or trial arm.	Description of Method of Assignment to Trial Intervention
	Description of Trial Duration		C218726		A description of the trial duration.	Description of Trial Duration
	End of Trial		C218737		A description containing a concise explanation, any local regulatory requirements and considerations, extensions, follow-up, and analysis for the trial end.	End of Trial Explanation
	Overall Description of Trial Design and Description of Intervention Model		C147139		A description summarizing the overall trial design and intervention model.	Study Design Description
	Overall Rationale for Trial Design		C142705		An explanation as to the scientific reasons for the choice of the trial design.	Study Design Rationale
	Rationale for Adaptive or Novel Trial Design		C218733		An explanation as to the scientific reasons for why an adaptive or novel trial design was chosen for the trial.	Rationale for Adaptive or Novel Trial Design
	Rationale for Control Type		C218731		An explanation as to the scientific reasons for the choice of the control types used in the trial.	Rationale for Trial Control Type
	Rationale for Estimand(s)		C218730		An explanation as to the scientific reasons for the choice of the trial estimand(s).	Rationale for Trial Estimand
	Rationale for Interim Analysis		C218734		An explanation for the analysis comparing intervention groups at any time before the formal completion of the trial, usually before recruitment is complete.	Rationale for Interim Analysis
	Rationale for Intervention Model		C215629		An explanation as to the scientific reasons for why the intervention model was chosen for the trial.	Interventional Study Design Rationale
	Rationale for Other Trial Design Aspects		C218735		An explanation as to the scientific reasons for additional trial design considerations that are different than the one(s) previously specified or mentioned.	Rationale for Other Trial Design Aspects
	Rationale for Trial Duration		C218732		An explanation as to the scientific reasons for the trial duration.	Rationale for Trial Duration
	Stakeholder Input into Design		C218729		A description of the way in which trial stakeholders were consulted when determining the trial design and how that input was applied.	Stakeholder Input into Trial Design
	Start of Trial		C218736		A description containing a concise explanation, any local regulatory requirements and considerations, extensions, follow-up, and analysis for the trial start.	Start of Trial Explanation
	Trial Stopping Rules		C142698		A criterion that, when met by the accumulating data, indicates that the trial can or should be stopped early to avoid putting participants at risk unnecessarily or because the intervention effect is so great that further data collection is unnecessary.	Stopping Rules
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CL.C217346.ICH M11 Section 5 Terminology	ICH M11 Section 5 Terminology (ICH M11 Section 5 Terminology)	text Extensible: No	C217346	ICH M11 Section 5 Terminology	Terminology relevant to the data elements in section 5 of the ICH M11 protocol template.	ICH M11 Protocol Section 5 Data Element Terminology
	Caffeine, Alcohol, Tobacco, and Other Restrictions		C218744		A description of the restrictions related to participant intake of caffeine, alcohol, tobacco, and other habit-forming substances during the trial.	Trial Participant Caffeine, Alcohol, Tobacco, and Other Substance Restrictions
	Contraception Requirements		C218741		A description of the requirements for the prevention of conception or impregnation by the use of devices or drugs or surgery within a context of a trial, or state not applicable.	Trial Participant Contraception Requirements
	Definitions Related to Childbearing Potential		C218740		A concise explanation of the meaning of participants of childbearing potential and nonchildbearing potential within the context of a trial, or state not applicable.	Definitions Related to Trial Participant Childbearing Potential
	Description of Trial Population and Rationale		C218739		A description of the rationale for selection of trial population describing how the selected population can meet the trial objectives and how the enrollment criteria reflect the targeted populations.	Description of Trial Population and Rationale
	Exclusion Criterion		C25370		List of characteristics in a protocol, any one of which excludes a potential participant from participation in a study. (CDISC glossary)	Exclusion Criteria
	Inclusion Criterion		C25532		The criteria in a protocol that prospective participants must meet to be eligible for participation in a study. (CDISC glossary)	Inclusion Criteria
	Lifestyle Restrictions		C218742		A description of the restrictions related to trial participant lifestyle such as diet, substance intake, and physical or other daily activities.	Trial Participant Lifestyle Restrictions
	Meals and Dietary Restrictions		C218743		A description of the restrictions related to participant diet during the trial.	Trial Participant Meals and Dietary Restrictions
	Other Activity Restrictions		C218746		An activity restriction that is different than the one(s) previously specified or mentioned.	Other Activity Restrictions
	Physical Activity Restrictions		C218745		A description of the restrictions related to participant physical activity during the trial.	Trial Participant Physical Activity Restrictions
	Rescreening		C179373		The process of active consideration of participants for enrollment in a trial, for those potential participants who have failed a prior screening attempt.	Rescreening
	Screen Failure		C49628		The potential participant who does not meet eligibility (inclusion/exclusion) criteria during the screening period.	Trial Screen Failure
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CL.C217347.ICH M11 Section 6 Terminology	ICH M11 Section 6 Terminology (ICH M11 Section 6 Terminology)	text Extensible: No	C217347	ICH M11 Section 6 Terminology	Terminology relevant to the data elements in section 6 of the ICH M11 protocol template.	ICH M11 Protocol Section 6 Data Element Terminology
	Accountability of Investigational Trial Intervention		C176267		The act or process for documenting the storage, inventory tracking, and disposition of the investigational trial intervention.	Study Product Accountability
	Arm Name		C93729		The literal identifier (i.e. distinctive designation) for the arm.	Arm Name
	Arm Type		C172457		A characterisation or classification of the study arm.	Study Arm Type
	Background Trial Intervention		C222329		Description of medicinal products that are administered to each clinical trial participant, regardless of randomisation group, a) to treat the indication which is the object of the study, or b) required in the protocol as part of standard care for a condition that is not the indication under investigation, and is relevant for the clinical trial design. (CDISC Glossary)	Description of Background Trial Intervention
	Concomitant Therapy		C53630		Description of any pharmaceutical agent, other than the trial interventions, that is administered to or used by the participant prior to or during a specified time period.	Concomitant Therapy
	Description of Investigational Trial Intervention		C218751		A description of the investigational trial intervention.	Description of Investigational Trial Intervention
	Description of Noninvestigational Trial Intervention		C218759		A description of the noninvestigational trial intervention.	Description of Noninvestigational Trial Intervention
	description of the overview of trial interventions or a heading for the optional table		C218747		A free text description of the trial intervention; alternatively can be used as a heading for a table containing information about the trial intervention.	Trial Intervention Overview or Informational Table Header
	Dosage Level(s)		C94394		Specified quantity of a medicine, to be taken at one time or at stated intervals.	Cumulative Dose
	Dosage Strength(s)		C142517		The strength of a drug product, which indicates the amount of each active ingredient in a given dosage form, measured in units of volume or concentration.	Dose Strength
	Emergency Unblinding at the Site		C218757		A description of the methodology used for unblinding of the trial treatment in the case of a sudden unforeseen crisis that requires immediate medical care of the participant.	Emergency Unblinding at the Site
	IMP or NIMP		C218749		An indication as to whether the trial intervention is an investigational medicinal product or an auxiliary medicinal product.	IMP or NIMP Indicator
	Intervention Name		C177930		The literal identifier (i.e. distinctive designation) for the study intervention.	Intervention Name
	Intervention Type		C98747		The kind of product or procedure studied in a trial.	Intervention Type
	Investigational Trial Intervention Adherence		C218758		A description of the measures taken to ensure trial intervention adherence, including mandatory documentation to be filled out and the source data that will be used to document investigational trial intervention compliance.	Investigational Trial Intervention Adherence Measures Description
	Investigational Trial Intervention Administration		C218753		The way in which the investigational trial intervention is dispensed, applied, or tendered to the trial participant.	Investigational Trial Intervention Administration
	Investigational Trial Intervention Dose Modification		C218754		A change, alteration, or adjustment to the dose of an investigational trial intervention.	Investigational Trial Intervention Dose Modification
	Management of Investigational Trial Intervention Overdose		C218755		A description of how a potential investigational trial intervention overdose will be handled.	Management of Investigational Trial Intervention Overdose
	Measures to Maintain Blinding		C189349		A description of the measures taken to ensure the blinding is maintained.	Study Blinding Procedure
	Other Noninvestigational Trial Intervention		C218761		Description of any noninvestigational intervention that is different than the one(s) previously specified or mentioned.	Description of Other Noninvestigational Trial Intervention
	Participant Assignment to Investigational Trial Intervention		C218756		The technique used to assign trial participants to a trial arm.	Participant Assignment to Investigational Intervention Method
	Permitted Concomitant Therapy		C218763		Concomitant therapy that is approved for use in the trial.	Permitted Concomitant Therapy
	Pharmaceutical Dose Form		C42636		Physical characteristics of a drug product, (e.g., tablet, capsule, or solution) that contains a drug substance, generally-but not necessarily-in association with one or more other ingredients. (CDISC Glossary)	Pharmaceutical Dosage Form
	Preparation of Investigational Trial Intervention		C176274		The way in which the investigational trial intervention is prepared for use or administration to the trial participant.	Study Product Preparation
	Prohibited Concomitant Therapy		C218762		Concomitant therapy that is banned from use in the trial.	Prohibited Concomitant Therapy
	Randomisation		C25196		The process of assigning trial participants to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (CDISC Glossary)	Randomization
	Rationale for Investigational Trial Intervention Dose and Regimen		C218752		An explanation as to the scientific reasons for the choice of the trial intervention dose and dose regimen.	Rationale for Investigational Trial Intervention Dose and Regimen
	Regimen/Treatment Period/Vaccination Regimen		C15697		A description of the schedule and periodicity of a treatment or vaccination regimen.	Treatment Regimen
	Rescue Therapy		C222330		Description of any rescue medications, treatments, and/or procedures identified in the protocol as those that may be administered to participants when the efficacy of the investigational intervention is not satisfactory, its effect is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.	Description of Rescue Therapy
	Route of Administration		C38114		Path by which the pharmaceutical product is taken into or makes contact with the body.	Route of Administration
	Sourcing		C218750		An indication as to whether the investigational intervention is centrally or locally sourced.	Investigational Intervention Sourcing Indicator
	Storage and Handling of Investigational Trial Intervention		C115525		A narrative description containing information about the handling, storage, and distribution of investigational trial intervention.	Clinical Trial Investigational Product Handling Instruction Documentation
	Use		C218748		The reason or intention for the use of the trial intervention within the trial arm.	Trial Intervention Intent
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CL.C217348.ICH M11 Section 7 Terminology	ICH M11 Section 7 Terminology (ICH M11 Section 7 Terminology)	text Extensible: No	C217348	ICH M11 Section 7 Terminology	Terminology relevant to the data elements in section 7 of the ICH M11 protocol template.	ICH M11 Protocol Section 7 Data Element Terminology
	Management of Loss to Follow-Up		C218768		The mitigation strategies to be employed for the loss or lack of continuation of a participant to follow-up, including the frequency by which follow-up occurs.	Management of Loss to Follow-Up
	Participant Discontinuation or Withdrawal from Trial		C218767		The rationale for why the participant either discontinued or withdrew from the trial.	Study Subject Discontinuation Rationale
	Permanent Discontinuation of Trial Intervention		C218764		The requirements that must be met in order to permanently discontinue the administration of trial intervention.	Requirements for Permanent Discontinuation of Trial Intervention
	Rechallenge		C218766		The requirements that must be met in order to reintroduce previously withdrawn or temporarily discontinued medical intervention in the same participant.	Rechallenge Requirement
	Temporary Discontinuation of Trial Intervention		C218765		The requirements that must be met in order to temporarily discontinue the administration of trial intervention.	Requirements for Temporary Discontinuation of Trial Intervention
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CL.C217349.ICH M11 Section 8 Terminology	ICH M11 Section 8 Terminology (ICH M11 Section 8 Terminology)	text Extensible: No	C217349	ICH M11 Section 8 Terminology	Terminology relevant to the data elements in section 8 of the ICH M11 protocol template.	ICH M11 Protocol Section 8 Data Element Terminology
	Baseline Assessments and Procedures		C218771		Trial assessments and procedures related to the baseline epoch of the trial.	Baseline Assessments and Procedures Description
	Clinical Laboratory Assessments		C218774		Trial-related laboratory assessments and procedures.	Clinical Laboratory Assessment
	Efficacy Assessments and Procedures		C218772		Trial assessments and procedures related to trial intervention efficacy.	Efficacy Assessments and Procedures Description
	Electrocardiograms		C168186		The procedures for the recordings produced by the variations in electrical potential caused by electrical activity of the heart muscle and detected at the body surface, as a method for studying the action of the heart muscle.	Electrocardiogram
	Genetics, Genomics, Pharmacogenetics and Pharmacogenomics		C218777		A narrative description containing information about the collection, use, and retention of biospecimens, and their use in genetic, genomic, pharmacogenetic and pharmacogenomic biomarker assessments within the trial.	Genetics, Genomics, Pharmacogenetics and Pharmacogenomics Assessment
	Immunogenicity Assessments		C218780		A narrative description containing information about the collection, use, and retention of biospecimens, and their use in immunogenicity assessments within the trial.	Immunogenicity Assessment
	Medical Resource Utilisation and Health Economics		C176849		A narrative description containing information about medical resource utilisation and the health outcome measures, collection method and participant burden.	Healthcare Utilization
	Other Biomarkers		C218779		A narrative description containing information about the collection, use, and retention of biospecimens, and their use in other biomarker assessments within the trial.	Other Biomarker Assessment
	Pharmacodynamic Biomarkers		C218778		A narrative description containing information about the collection, use, and retention of biospecimens, and their use in pharmacodynamic biomarker assessments within the trial.	Pharmacodynamics Assessment
	Pharmacokinetics		C218776		A narrative description containing information about the collection, use, and retention of biospecimens, and their use in pharmacokinetic assessments within the trial.	Pharmacokinetic Assessment
	Physical Examination		C20989		The procedures for a physical examination of the body and its functions to be conducted for the trial.	Physical Examination
	Pregnancy Testing		C92949		Any examination performed to assess if a female is gravid.	Pregnancy Test
	Safety Assessments and Procedures		C218773		A description of the assessments and procedures related to participant safety within the trial.	Safety Assessments and Procedures Description
	Screening Assessments and Procedures		C218770		Trial assessments and procedures related to the screening epoch of the trial.	Screening Assessments and Procedures Description
	Suicidal Ideation and Behaviour Risk Monitoring		C218775		A description of data collection procedures and analysis related to suicidal ideation and behaviour risk monitoring.	Suicidal Ideation and Behaviour Risk Monitoring
	Trial Assessments and Procedures Considerations		C218769		A description of general considerations applicable across trial assessments and procedures.	Trial Assessments and Procedures Considerations Description
	Vital Signs		C154628		The procedures for measurements of the body's basic functions that provide insight into the health status of the person.	Vital Signs
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CL.C217350.ICH M11 Section 9 Terminology	ICH M11 Section 9 Terminology (ICH M11 Section 9 Terminology)	text Extensible: No	C217350	ICH M11 Section 9 Terminology	Terminology relevant to the data elements in section 9 of the ICH M11 protocol template.	ICH M11 Protocol Section 9 Data Element Terminology
	Adverse Events of Special Interest		C217358		A description of the processes and procedures used to define, measure, confirm, and report the occurrence of adverse events that are of special interest to the specific trial, or state not applicable.	Adverse Event of Special Interest
	Back-up Method for Reporting		C218790		A description of alternative techniques by which trial related events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events, are reported to the sponsor and/or regulatory authority.	Trial Event Back-Up Reporting Method
	Causality		C82552		The description of the degree of causality (attributability) between a trial intervention and an event.	Causality
	Definitions of Adverse Events		C218476		A concise explanation of the meaning of adverse events within the context of the trial.	Definition of Adverse Events
	Definitions of Medical Device Product Complaints		C218783		A concise explanation of the meaning of medical device product complaints within the context of the trial.	Definition of Medical Device Product Complaints
	Definitions of Product Complaints		C218782		A concise explanation of the meaning of product complaints within the context of the trial.	Definition of Product Complaints
	Definitions of Serious Adverse Events		C218781		A concise explanation of the meaning of serious adverse events within the context of the trial.	Definition of Serious Adverse Events
	Disease-related Events or Outcomes Not Qualifying as AEs or SAEs		C218797		A description of events or outcomes related to the trial disease indication but not qualifying as adverse events or serious adverse events within the trial, or state not applicable.	Disease-related Events or Outcomes Not Qualifying as Adverse Events or Serious Adverse Events
	Event Collection and Reporting Timing		C218791		A description of the timing as it relates to the collection and reporting of trial related events, and the frequency of collection of those events to the sponsor or designee.	Event Collection and Reporting Timing Description
	Event Type		C218784		A characterisation or classification of trial-related safety events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events.	Trial-Related Safety Event Type
	Follow-up		C218794		A description of the procedures for follow-up, including the assessment tools that will be used to monitor an event and the duration of follow-up.	Event Follow-up Procedure Description
	Identification		C218792		A description of how trial-related events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events, will be identified.	Trial-Related Event Identification
	Method for Reporting		C218789		A description of the technique by which trial related events, such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events, are reported to the sponsor and/or regulatory authority.	Trial Event Reporting Method
	Other Event Type		C222263		An event type that is different than the one(s) previously specified or mentioned.	Other Trial-Related Safety Event Type
	Participants Who Become Pregnant During the Trial		C218798		A description of the processes and procedures used to collect pregnancy data for a trial participant who becomes pregnant while the participant is in the trial, as well as data collection about the foetus, neonate, infant, or child.	Participants Who Become Pregnant During the Trial Data Collection
	Participants Whose Partners Become Pregnant During the Trial		C218799		A description of the processes and procedures used to collect pregnancy data for a trial participant's partner, who becomes pregnant while the participant is in the trial.	Participants Whose Partners Become Pregnant During the Trial Data Collection
	Recording		C218793		A description for the procedures used to document an event.	Event Recording Procedure Description
	Regulatory Reporting Requirements		C218796		A description of the requirements for the sponsor/designee to report adverse events, serious adverse events, pregnancy and postpartum events, and medical device product complaints, including the criteria for reporting, to the relevant regulatory authority.	Regulatory Reporting Requirements for Trial-Related Events
	Reportable Period End		C218787		The date on which reporting will cease for trial related events such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events.	Reportable Period End Date
	Reportable Period Start		C218786		The date on which reporting will begin for trial related events such as adverse events, serious adverse events, product complaints, medical device product complaints, and pregnancy and postpartum events.	Reportable Period Start Date
	Reporting		C218795		A description of the method and timelines for reporting adverse events, serious adverse events, pregnancy and postpartum events, and medical device product complaints to the sponsor.	Event Reporting Procedure Description
	Severity		C25676		The description of the intensity (severity) of an event.	Severity
	Situational Scope		C218785		A description of the specific circumstances and context in which safety events are collected and monitored.	Safety Event Situational Scope Description
	Special Safety Situations		C218800		A characterisation or classification of those trial specific situations that are associated with the trial intervention(s) and require regulatory reporting, but that do not qualify as an adverse event or serious adverse event for the given trial.	Special Safety Situation Type
	Timing for Reporting to Sponsor or Designee		C218788		A description of the timing window between trial related events and their reporting to the sponsor or designee.	Timing Description for Reporting to Sponsor or Designee
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CL.C217357.ICH M11 Section Amendment Details Terminology	ICH M11 Section Amendment Details Terminology (ICH M11 Section Amendment Details Terminology)	text Extensible: No	C217357	ICH M11 Section Amendment Details Terminology	Terminology relevant to the data elements in the amendment details section of the ICH M11 protocol template.	ICH M11 Protocol Section Amendment Details Data Element Terminology
	Amendment Details		C218694		A written message within the study protocol that describes the amendment details, especially as to whether the protocol has been amended previously.	Protocol Amendment Details
	Amendment Scope Enrollment Definition		C218695		The enrollment description as to whether the amendment scope applies globally, locally, or per cohort across the trial.	Amendment Scope Enrollment Description
	Amendment Summary		C42581		A short description describing the changes introduced in the current version of the protocol.	Summary
	Approximately <#/%> enrolled		C218478		The value (expressed either numerically or as a percentage) for the estimated number of participants enrolled at the time of the protocol amendment.	Approximate Participant Enrollment At Time of Sponsor Approval
	Brief Rationale for Change		C181233		The brief reason for the change introduced in the current or prior version of the protocol.	Brief Rationale for Protocol Change
	Briefly Explain Substantial Impact on Data		C218701		A short descriptive account of any substantial impacts on the reliability and robustness of the data generated in the clinical trial due to the protocol amendment.	Brief Explanation of Substantial Impact on Study Data
	Briefly Explain Substantial Impact On Safety		C218699		A short descriptive account of any substantial impacts on the safety or rights of the participants due to the protocol amendment.	Brief Explanation of Substantial Impact on Participant Safety
	Description of Change		C218483		A description of the change introduced in the current or prior version of the protocol.	Description of Protocol Change
	Is this amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial?		C218700		An indication as to whether the amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial.	Amendment Impacts Reliability and Robustness of Data Indicator
	Is this amendment likely to have a substantial impact on the safety or rights of the participants?		C218698		An indication as to whether the amendment is likely to have a substantial impact on the safety or rights of the participants.	Amendment Impacts Participant's Safety or Rights Indicator
	Primary Reason for Amendment		C218696		The rationale of greatest importance for the protocol amendment.	Primary Reason for Protocol Amendment
	Secondary Reason for Amendment		C218697		Additional rationale for the protocol amendment that is not considered the primary rationale.	Secondary Reason for Protocol Amendment
	Section # and Name		C218479		The protocol section number and name containing the change introduced in the current or prior version of the protocol.	Protocol Change Section Number and Name
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CL.C217356.ICH M11 Section Title Page Terminology	ICH M11 Section Title Page Terminology (ICH M11 Section Title Page Terminology)	text Extensible: No	C217356	ICH M11 Section Title Page Terminology	Terminology relevant to the data elements in the title page of the ICH M11 protocol template.	ICH M11 Protocol Section Title Page Data Element Terminology
	Amendment Identifier		C218477		A sequence of characters used to uniquely identify a protocol amendment.	Amendment Identifier
	Amendment Scope		C218673		A description as to whether the amendment scope applies globally across the trial.	Amendment Scope Global Applicability Indicator
	Approval Date		C132352		The date that the sponsor approved a version of the protocol.	Protocol Approval by Sponsor Date
	Co-Sponsor Legal Address		C218679		The legally registered address of the trial co-sponsor.	Co-Sponsor Legal Address
	Co-Sponsor Name		C218678		The literal identifier (i.e., distinctive designation) of the trial co-sponsor.	Co-Sponsor Name
	Country Identifier		C20108		A sequence of characters used to identify and/or name the country.	Country Code
	Device Manufacturer Legal Address		C218683		The legally registered address of the device manufacturer.	Device Manufacturer Legal Address
	Device Manufacturer Name		C218682		The literal identifier (i.e., distinctive designation) of the organisation defined as being responsible for creating the device as stated on the package in which the product is supplied.	Device Manufacturer Name
	EU CT Number		C218684		A sequence of characters used to identify a clinical trial, as assigned by the Clinical Trials Information System (CTIS) of the European Medicines Agency.	EU Clinical Trial Register Number
	FDA IND Number		C218685		A sequence of characters used to identify a clinical trial under an Investigational New Drug (IND) application, as assigned by the US Food and Drug Administration.	US FDA Investigational New Drug Application Number
	Full Title		C132346		The formal descriptive name for the protocol that contains key elements of the study. (CDISC)	Official Protocol Title
	IDE Number		C218686		A sequence of characters used to identify a clinical trial under an Investigational Device Exemption (IDE) application, as assigned by the US Food and Drug Administration.	US FDA Investigational Device Exemption Application Number
	jRCT Number		C218687		A sequence of characters used to identify a clinical trial, as assigned by the Japan Registry for Clinical Trials (JRCT) of the Ministry of Health, Labour and Welfare (MHLW) in Japan.	Japan Registry for Clinical Trials Number
	Local Sponsor Legal Address		C218681		The legally registered address of the sponsor's legal representative at a geographical region within which the sponsor has no legal presence.	Local Sponsor Legal Address
	Local Sponsor Name		C218680		The literal identifier (i.e., distinctive designation) of the sponsor's legal representative at a geographical region within which the sponsor has no legal presence.	Local Sponsor Name
	Medical Expert contact information (as designated by sponsor)		C218693		The contact information for the sponsor's representative who can advise on specific trial-related medical questions or problems.	Designated Medical Expert Contact Information
	NCT Number		C172240		A sequence of characters used to identify a clinical trial, as assigned by the protocol registration and results (PRS) system of the US National Library of Medicine.	Clinicaltrials.gov Identifier
	NMPA IND Number		C218688		A sequence of characters used to identify a clinical trial under an Investigational New Drug (IND) application, as assigned by the Chinese National Medicinal Products Administration (NMPA).	NMPA IND Number
	Nonproprietary Name(s)		C97054		Drug name that is not protected by a trademark, usually descriptive of its chemical structure, and sometimes a public name.	Generic Name
	Original Protocol Indicator		C218672		An indication as to whether the protocol document reflects the original version of the protocol.	Original Protocol Indicator
	Other Regulatory or Clinical Trial Identifier		C218690		A sequence of characters assigned by a regulatory agency or other health authority that is used to identify a clinical trial, and that is different than the one(s) previously specified or mentioned.	Other Regulatory or Clinical Trial Identifier
	Proprietary Name(s)		C71898		A commercial name granted by an authority for use in marketing/registering a product.	Proprietary Name
	Region Identifier		C218674		A sequence of characters used to identify and/or name the region.	Region Identifier
	Site Identifier		C83081		A sequence of characters used to identify and/or name the study site.	Study Site Identifier
	Sponsor Confidentiality Statement		C181236		A written message within the study protocol that asserts a statement of non-disclosure, such that information contained within the protocol document may only be shared with authorised parties.	Protocol Confidentiality Statement
	Sponsor Legal Address		C218677		The legally registered address of the trial sponsor.	Sponsor Legal Address
	Sponsor Name		C222495		The literal identifier (i.e., distinctive designation) of the trial sponsor.	Trial Sponsor Name
	Sponsor Protocol Identifier		C132351		A sequence of characters assigned by the sponsor that uniquely identifies a specific protocol.	Sponsor Protocol Identifier
	sponsor signatory (e.g., name, title, signature and date)		C222014		A block of text containing the name and signature of the sponsor's signatory, along with the signature date.	Sponsor Signatory
	Sponsor's Investigational Product Code(s)		C218675		A symbol or combination of symbols that are assigned by the sponsor to uniquely identify an experimental intervention.	Sponsor's Investigational Product Code
	state location where Medical Expert contact information can be found		C222063		The physical or virtual location of the medical expert (as designated by the sponsor) contact information.	Location of Medical Expert Contact Information
	State location where sponsor approval information can be found		C218484		The physical or virtual location of the date on which the sponsor approved the current version of the protocol.	Location of Sponsor Approval Date
	state location where sponsor signatory information can be found (e.g., electronic signature)		C222064		The physical or virtual location of the sponsor signatory information.	Location of Sponsor Signatory Information
	Trial Acronym		C94108		Acronym or abbreviation used publicly to identify the clinical trial.	Study Protocol Version Acronym
	Trial Phase		C48281		A stage in the clinical research and development of a therapy from first-in-human to post-approval clinical trials.	Trial Phase
	Trial Short Title		C94105		The short descriptive name for the trial.	Study Protocol Document Version Public Title
	Version Date		C93813		The date on which the document is versioned.	Document Version Date
	Version Number		C181232		A string of alphanumeric characters that uniquely identifies a specific version of a study protocol.	Study Protocol Version Number
	WHO/UTN Number		C218689		A sequence of characters used to identify a clinical trial, as assigned by the World Health Organisation's International Clinical Trial's Registry Platform (ICTRP).	WHO/UTN Number
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CL.C217282.Independent Committee Name Response Terminology	Independent Committee Name Response Terminology (Independent Committee Name Response Terminology)	text Extensible: No	C217282	Independent Committee Name Response Terminology	A valid value set relevant to the independent committee name responses within the ICH M11 protocol template.	ICH M11 Independent Committee Name Value Set Terminology
	Dose Escalation Committee		C215671		A type of safety monitoring committee that monitors dose escalation activities in first-in-human trials.	Dose Escalation Committee
	Endpoint Adjudication Committee		C78726		An external committee whose purpose is to evaluate study data and decide whether a study endpoint or other criterion has been met.	Adjudication Committee
	Independent Data Monitoring Committee		C142578		A committee established by the sponsor to assess at intervals the progress of a clinical trial, safety data, and critical efficacy variables and recommend to the sponsor whether to continue, modify, or terminate the trial.	Independent Data Monitoring Committee
	None		C41132		No person or thing, nobody, not any.	None
	Other		C17649		Different than the one(s) previously specified or mentioned.	Other
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CL.C217277.Intervention Model Response Terminology	Intervention Model Response Terminology (Intervention Model Response Terminology)	text Extensible: No	C217277	Intervention Model Response Terminology	A valid value set relevant to the intervention model responses within the ICH M11 protocol template.	ICH M11 Intervention Model Value Set Terminology
	Cross-over		C82637		Participants receive one of two or more alternative intervention(s) during the initial epoch of the study and receive other intervention(s) during the subsequent epoch(s) of the trial.	Crossover Study
	Factorial		C82638		Two or more interventions, each alone or in combination, are evaluated in parallel against a control group. This study design allows for the comparison of active drug to placebo, presence of drug-drug interactions, and comparison of active drugs against each other.	Factorial Study
	Other		C17649		Different than the one(s) previously specified or mentioned.	Other
	Parallel Group		C82639		Participants are assigned to one of two or more treatment groups in parallel for the duration of the study.	Parallel Study
	Sequential		C142568		Groups of participants are assigned to receive interventions based on prior milestones being reached in the study.	Group Sequential Design
	Single Group		C82640		All trial participants are assigned to a single treatment group for the duration of the study.	Single Group Study
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CL.C217284.Intervention Type Response Terminology	Intervention Type Response Terminology (Intervention Type Response Terminology)	text Extensible: No	C217284	Intervention Type Response Terminology	A valid value set relevant to the intervention type responses within the ICH M11 protocol template.	ICH M11 Intervention Type Value Set Terminology
	Behavioural		C15184		A technique used to change the behavior of a participant (e.g., psychotherapy, lifestyle counseling, or hypnosis).	Behavioral Intervention
	Biologic		C307		A product of biological origin applicable to the prevention, treatment, or cure of a disease or condition, for example: virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product.	Biological Agent
	Combination Product		C54696		A product composed of two or more different types of medical products (i.e., a combination of a drug, device, and/or biological product with one another and are referred to as "constituent parts" of the combination product). (CDISC Glossary)	Combination Product
	Diagnostic		C18020		Any procedure or test to diagnose a disease or disorder.	Diagnostic Procedure
	Dietary Supplement		C1505		Preparations containing ingredient(s) intended to supplement the diet.	Dietary Supplement
	Drug		C1909		An active natural, synthetic or semi-synthetic ingredient including endogenous body substance that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.	Pharmacologic Substance
	Genetic		C15238		Introduction of genetic material into cells in order to correct or treat an inherited or acquired disease.	Gene Therapy
	Medical Device		C16830		Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for, one or more specific medical purpose(s). (CDISC Glossary)	Medical Device
	Non-Surgical Procedure		C218507		A medical procedure that produces an effect, or that is intended to alter the course of a disease in a patient or population, which is not considered a surgical procedure.	Non-Surgical Procedure
	Radiation		C15313		Use of targeted or whole body radiation to treat a disease.	Radiation Therapy
	Surgery		C15329		A diagnostic or treatment procedure performed by manual and/or instrumental means, often involving an incision and the removal or replacement of a diseased organ or tissue; of or relating to or involving or used in surgery or requiring or amenable to treatment by surgery.	Surgical Procedure
	Vaccine		C923		A medicinal product inducing immunity against disease, most often to prevent occurrence of a disease, (e.g., a preventative vaccine against infectious disease), but also to treat a disease, (e.g., a therapeutic vaccine against cancer). (CDISC Glossary)	Vaccine
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CL.C217285.Intervention Use Response Terminology	Intervention Use Response Terminology (Intervention Use Response Terminology)	text Extensible: No	C217285	Intervention Use Response Terminology	A valid value set relevant to the intervention use responses within the ICH M11 protocol template.	ICH M11 Intervention Use Value Set Terminology
	Additional Required Treatment		C207614		A medicinal product that must be administered along with the experimental treatment (e.g., drug studies wherein opioid blockers are administered to prevent overdose).	Additional Required Medicinal Product
	Background Treatment		C165822		Medicinal products that are administered to each clinical trial participant, regardless of randomisation group, a) to treat the indication which is the object of the study, or b) required in the protocol as part of standard care for a condition that is not the indication under investigation, and is relevant for the clinical trial design. (CDISC Glossary)	Background Treatment
	Challenge Agent		C158128		A non-investigational medicinal product (NIMP) given to trial participants to produce a physiological response that is necessary before the pharmacological action of the investigational medicinal product can be assessed. (CDISC Glossary)	Challenge Agent
	Diagnostic		C18020		Any procedure or test to diagnose a disease or disorder.	Diagnostic Procedure
	Experimental Intervention		C41161		The drug, device, therapy, procedure, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., health-related quality of life, efficacy, safety, pharmacoeconomics). (CDISC Glossary)	Protocol Agent
	Placebo		C753		A pharmaceutical preparation that does not contain the investigational agent and is generally prepared to be physically indistinguishable from the preparation containing the investigational product.	Placebo
	Rescue Medicine		C165835		Medicinal products identified in the protocol as those that may be administered to participants when the efficacy of the investigational medicinal product (IMP) is not satisfactory, the effect of the IMP is too great and is likely to cause a hazard to the patient, or to manage an emergency situation. (CDISC Glossary)	Rescue Medications
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CL.C217052.Investigational Intervention Sourcing Response Terminology	Investigational Intervention Sourcing Response Terminology (Investigational Intervention Sourcing Response Terminology)	text Extensible: No	C217052	Investigational Intervention Sourcing Response Terminology	Terminology associated with the sourcing value set codelist of the ICH M11 protocol template.	ICH M11 Sourcing Value Set Terminology
	Centrally Sourced		C215659		An indication that the entity is obtained from a central source.	Centrally Sourced Indicator
	Locally Sourced		C215660		An indication that the entity is obtained from a local source.	Locally Sourced Indicator
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CL.C217286.Investigational Medicinal Product Indicator Response Terminology	Investigational Medicinal Product Indicator Response Terminology (Investigational Medicinal Product Indicator Response Terminology)	text Extensible: No	C217286	Investigational Medicinal Product Indicator Response Terminology	A valid value set relevant to the investigational medicinal product indicator responses within the ICH M11 protocol template.	ICH M11 Investigational Medicinal Product Indicator Value Set Terminology
	IMP		C202579		A medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial.	Investigational Medicinal Product
	NIMP		C156473		A medicinal product that is related to the specific needs of the clinical trial as described in the protocol, but not as an investigational medicinal product. (CDISC Glossary)	Auxiliary Medicinal Product
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CL.C217046.No Yes Response Terminology	No Yes Response Terminology (No Yes Response Terminology)	text Extensible: No	C217046	No Yes Response Terminology	Terminology associated with the no yes value set codelist of the ICH M11 protocol template.	ICH M11 No Yes Value Set Terminology
	No		C49487		The non-affirmative response to a question.	No
	Yes		C49488		The affirmative response to a question.	Yes
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CL.C217278.Population Type Response Terminology	Population Type Response Terminology (Population Type Response Terminology)	text Extensible: No	C217278	Population Type Response Terminology	A valid value set relevant to the population type responses within the ICH M11 protocol template.	ICH M11 Population Type Value Set Terminology
	With Disease		C218503		An indication that the individual or group of individuals has been diagnosed with the disease of interest or under study.	With Disease
	Without Disease		C218504		An indication that the individual or group of individuals has not been diagnosed with the disease of interest or under study.	Without Disease
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CL.C217272.Protocol Section Name and Number Response Terminology	Protocol Section Name and Number Response Terminology (Protocol Section Name and Number Response Terminology)	text Extensible: No	C217272	Protocol Section Name and Number Response Terminology	A valid value set relevant to the protocol section name and number responses within the ICH M11 protocol template.	ICH M11 Protocol Section Name and Number Value Set Terminology
	1 PROTOCOL SUMMARY		C218514		Section 1 of the ICH M11 Protocol standard, PROTOCOL SUMMARY.	ICH M11 Protocol Section 1 PROTOCOL SUMMARY
	1.1 Protocol Synopsis		C218515		Section 1.1 of the ICH M11 Protocol standard, Protocol Synopsis.	ICH M11 Protocol Section 1.1 Protocol Synopsis
	1.1.1 Primary and Secondary Objectives and Estimands		C218516		Section 1.1.1 of the ICH M11 Protocol standard, Primary and Secondary Objectives and Estimands.	ICH M11 Protocol Section 1.1.1 Primary and Secondary Objectives and Estimands
	1.1.2 Overall Design		C218517		Section 1.1.2 of the ICH M11 Protocol standard, Overall Design.	ICH M11 Protocol Section 1.1.2 Overall Design
	1.2 Trial Schema		C218518		Section 1.2 of the ICH M11 Protocol standard, Trial Schema.	ICH M11 Protocol Section 1.2 Trial Schema
	1.3 Schedule of Activities		C218519		Section 1.3 of the ICH M11 Protocol standard, Schedule of Activities.	ICH M11 Protocol Section 1.3 Schedule of Activities
	10 STATISTICAL CONSIDERATIONS		C218625		Section 10 of the ICH M11 Protocol standard, STATISTICAL CONSIDERATIONS.	ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS
	10.1 General Considerations		C218626		Section 10.1 of the ICH M11 Protocol standard, General Considerations.	ICH M11 Protocol Section 10.1 General Considerations
	10.10 Multiplicity Adjustments		C218647		Section 10.10 of the ICH M11 Protocol standard, Multiplicity Adjustments.	ICH M11 Protocol Section 10.10 Multiplicity Adjustments
	10.11 Sample Size Determination		C218648		Section 10.11 of the ICH M11 Protocol standard, Sample Size Determination.	ICH M11 Protocol Section 10.11 Sample Size Determination
	10.2 Analysis Sets		C218627		Section 10.2 of the ICH M11 Protocol standard, Analysis Sets.	ICH M11 Protocol Section 10.2 Analysis Sets
	10.3 Analyses of Demographics and Other Baseline Variables		C218628		Section 10.3 of the ICH M11 Protocol standard, Analyses of Demographics and Other Baseline Variables.	ICH M11 Protocol Section 10.3 Analyses of Demographics and Other Baseline Variables
	10.4 Analyses Associated with the Primary Objective(s)		C218629		Section 10.4 of the ICH M11 Protocol standard, Analyses Associated with the Primary Objective(s).	ICH M11 Protocol Section 10.4 Analyses Associated with the Primary Objective(s)
	10.4.1 Primary Objective		C218630		Section 10.4.1 of the ICH M11 Protocol standard, Primary Objective.	ICH M11 Protocol Section 10.4.1 Primary Objective
	10.4.1.1 Statistical Analysis Method		C218631		Section 10.4.1.1 of the ICH M11 Protocol standard, Statistical Analysis Method.	ICH M11 Protocol Section 10.4.1.1 Statistical Analysis Method
	10.4.1.2 Handling of Data in Relation to Primary Estimand(s)		C218632		Section 10.4.1.2 of the ICH M11 Protocol standard, Handling of Data in Relation to Primary Estimand(s).	ICH M11 Protocol Section 10.4.1.2 Handling of Data in Relation to Primary Estimand(s)
	10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)		C218633		Section 10.4.1.3 of the ICH M11 Protocol standard, Handling of Missing Data in Relation to Primary Estimand(s)	ICH M11 Protocol Section 10.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)
	10.4.1.4 Sensitivity Analysis		C218634		Section 10.4.1.4 of the ICH M11 Protocol standard, Sensitivity Analysis.	ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis
	10.4.1.5 Supplementary Analysis		C218635		Section 10.4.1.5 of the ICH M11 Protocol standard, Supplementary Analysis.	ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis
	10.5 Analyses Associated with the Secondary Objective(s)		C218636		Section 10.5 of the ICH M11 Protocol standard, Analyses Associated with the Secondary Objective(s).	ICH M11 Protocol Section 10.5 Analyses Associated with the Secondary Objective(s)
	10.5.1 Secondary Objective		C218637		Section 10.5.1 of the ICH M11 Protocol standard, Secondary Objective.	ICH M11 Protocol Section 10.5.1 Secondary Objective
	10.5.1.1 Statistical Analysis Method		C218638		Section 10.5.1.1 of the ICH M11 Protocol standard, Statistical Analysis Method.	ICH M11 Protocol Section 10.5.1.1 Statistical Analysis Method
	10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)		C218639		Section 10.5.1.2 of the ICH M11 Protocol standard, Handling of Data in Relation to Secondary Estimand(s).	ICH M11 Protocol Section 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s)
	10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)		C218640		Section 10.5.1.3 of the ICH M11 Protocol standard, Handling of Missing Data in Relation to Secondary Estimand(s).	ICH M11 Protocol Section 10.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)
	10.5.1.4 Sensitivity Analysis		C218641		Section 10.5.1.4 of the ICH M11 Protocol standard, Sensitivity Analysis.	ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis
	10.5.1.5 Supplementary Analysis		C218642		Section 10.5.1.5 of the ICH M11 Protocol standard, Supplementary Analysis.	ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis
	10.6 Analyses Associated with the Exploratory Objective(s)		C218643		Section 10.6 of the ICH M11 Protocol standard, Analyses Associated with the Exploratory Objective(s).	ICH M11 Protocol Section 10.6 Analyses Associated with the Exploratory Objective(s)
	10.7 Safety Analyses		C218644		Section 10.7 of the ICH M11 Protocol standard, Safety Analyses.	ICH M11 Protocol Section 10.7 Safety Analyses
	10.8 Other Analyses		C218645		Section 10.8 of the ICH M11 Protocol standard, Other Analyses.	ICH M11 Protocol Section 10.8 Other Analyses
	10.9 Interim Analyses		C218646		Section 10.9 of the ICH M11 Protocol standard, Interim Analyses.	ICH M11 Protocol Section 10.9 Interim Analyses
	11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS		C218649		Section 11 of the ICH M11 Protocol standard, TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS.	ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
	11.1 Regulatory and Ethical Considerations		C218650		Section 11.1 of the ICH M11 Protocol standard, Regulatory and Ethical Considerations.	ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations
	11.10 Protocol Deviations		C218663		Section 11.10 of the ICH M11 Protocol standard, Protocol Deviations.	ICH M11 Protocol Section 11.10 Protocol Deviations
	11.11 Early Site Closure		C218664		Section 11.11 of the ICH M11 Protocol standard, Early Site Closure.	ICH M11 Protocol Section 11.11 Early Site Closure
	11.12 Data Dissemination		C218665		Section 11.12 of the ICH M11 Protocol standard, Data Dissemination.	ICH M11 Protocol Section 11.12 Data Dissemination
	11.2 Trial Oversight		C218651		Section 11.2 of the ICH M11 Protocol standard, Trial Oversight.	ICH M11 Protocol Section 11.2 Trial Oversight
	11.2.1 Investigator Responsibilities		C218652		Section 11.2.1 of the ICH M11 Protocol standard, Investigator Responsibilities.	ICH M11 Protocol Section 11.2.1 Investigator Responsibilities
	11.2.2 Sponsor Responsibilities		C218653		Section 11.2.2 of the ICH M11 Protocol standard, Sponsor Responsibilities.	ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities
	11.3 Informed Consent Process		C218654		Section 11.3 of the ICH M11 Protocol standard, Informed Consent Process.	ICH M11 Protocol Section 11.3 Informed Consent Process
	11.3.1 Informed Consent for Rescreening		C218655		Section 11.3.1 of the ICH M11 Protocol standard, Informed Consent for Rescreening.	ICH M11 Protocol Section 11.3.1 Informed Consent for Rescreening
	11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research		C218656		Section 11.3.2 of the ICH M11 Protocol standard, Informed Consent for Use of Remaining Samples in Exploratory Research.	ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research
	11.4 Committees		C218657		Section 11.4 of the ICH M11 Protocol standard, Committees.	ICH M11 Protocol Section 11.4 Committees
	11.5 Insurance and Indemnity		C218658		Section 11.5 of the ICH M11 Protocol standard, Insurance and Indemnity.	ICH M11 Protocol Section 11.5 Insurance and Indemnity
	11.6 Risk-Based Quality Management		C218659		Section 11.6 of the ICH M11 Protocol standard, Risk-Based Quality Management.	ICH M11 Protocol Section 11.6 Risk-Based Quality Management
	11.7 Data Governance		C218660		Section 11.7 of the ICH M11 Protocol standard, Data Governance.	ICH M11 Protocol Section 11.7 Data Governance
	11.8 Data Protection		C218661		Section 11.8 of the ICH M11 Protocol standard, Data Protection.	ICH M11 Protocol Section 11.8 Data Protection
	11.9 Source Records		C218662		Section 11.9 of the ICH M11 Protocol standard, Source Records.	ICH M11 Protocol Section 11.9 Source Records
	12 APPENDIX: SUPPORTING DETAILS		C218666		Section 12 of the ICH M11 Protocol standard, APPENDIX: SUPPORTING DETAILS.	ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS
	12.1 Clinical Laboratory Tests		C218667		Section 12.1 of the ICH M11 Protocol standard, Clinical Laboratory Tests.	ICH M11 Protocol Section 12.1 Clinical Laboratory Tests
	12.2 Country/Region-Specific Differences		C218668		Section 12.2 of the ICH M11 Protocol standard, Country/Region-Specific Differences.	ICH M11 Protocol Section 12.2 Country/Region-Specific Differences
	12.3 Prior Protocol Amendment(s)		C218669		Section 12.3 of the ICH M11 Protocol standard, Prior Protocol Amendment(s).	ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s)
	13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS		C218670		Section 13 of the ICH M11 Protocol standard, APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS.	ICH M11 Protocol Section 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS
	14 APPENDIX: REFERENCES		C218671		Section 14 of the ICH M11 Protocol standard, APPENDIX: REFERENCES.	ICH M11 Protocol Section 14 APPENDIX: REFERENCES
	2 INTRODUCTION		C218520		Section 2 of the ICH M11 Protocol standard, INTRODUCTION.	ICH M11 Protocol Section 2 INTRODUCTION
	2.1 Purpose of Trial		C218521		Section 2.1 of the ICH M11 Protocol standard, Purpose of Trial.	ICH M11 Protocol Section 2.1 Purpose of Trial
	2.2 Assessment of Risks and Benefits		C218522		Section 2.2 of the ICH M11 Protocol standard, Assessment of Risks and Benefits.	ICH M11 Protocol Section 2.2 Assessment of Risks and Benefits
	2.2.1 Risk Summary and Mitigation Strategy		C218523		Section 2.2.2 of the ICH M11 Protocol standard, Risk Summary and Mitigation Strategy.	ICH M11 Protocol Section 2.2.1 Risk Summary and Mitigation Strategy
	2.2.2 Benefit Summary		C218524		Section 2.2.1 of the ICH M11 Protocol standard, Benefit Summary.	ICH M11 Protocol Section 2.2.2 Benefit Summary
	2.2.3 Overall Risk-Benefit Assessment		C218525		Section 2.2.3 of the ICH M11 Protocol standard, Overall Risk-Benefit Assessment.	ICH M11 Protocol Section 2.2.3 Overall Risk-Benefit Assessment
	3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS		C218526		Section 3 of the ICH M11 Protocol standard, TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS.	ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS
	3.1 Primary Objective(s) and Associated Estimand(s)		C218527		Section 3.1 of the ICH M11 Protocol standard, Primary Objective(s) and Associated Estimand(s).	ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s)
	3.1.1 Primary Objective		C218528		Section 3.1.1 of the ICH M11 Protocol standard, Primary Objective.	ICH M11 Protocol Section 3.1.1 Primary Objective
	3.2 Secondary Objective(s) and Associated Estimand(s)		C218529		Section 3.2 of the ICH M11 Protocol standard, Secondary Objective(s) and Associated Estimand(s).	ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s)
	3.2.1 Secondary Objective		C218530		Section 3.2.1 of the ICH M11 Protocol standard, Secondary Objective.	ICH M11 Protocol Section 3.2.1 Secondary Objective
	3.3 Exploratory Objective(s)		C218531		Section 3.3 of the ICH M11 Protocol standard, Exploratory Objective(s).	ICH M11 Protocol Section 3.3 Exploratory Objective(s)
	3.3.1 Exploratory Objective		C218532		Section 3.3.1 of the ICH M11 Protocol standard, Exploratory Objective.	ICH M11 Protocol Section 3.3.1 Exploratory Objective
	4 TRIAL DESIGN		C218533		Section 4 of the ICH M11 Protocol standard, TRIAL DESIGN.	ICH M11 Protocol Section 4 TRIAL DESIGN
	4.1 Description of Trial Design		C218534		Section 4.1 of the ICH M11 Protocol standard, Description of Trial Design.	ICH M11 Protocol Section 4.1 Description of Trial Design
	4.1.1 Stakeholder Input into Design		C218535		Section 4.1.1 of the ICH M11 Protocol standard, Stakeholder Input into Design.	ICH M11 Protocol Section 4.1.1 Stakeholder Input into Design
	4.2 Rationale for Trial Design		C218536		Section 4.2 of the ICH M11 Protocol standard, Rationale for Trial Design.	ICH M11 Protocol Section 4.2 Rationale for Trial Design
	4.2.1 Rationale for Estimand(s)		C218537		Section 4.2.1 of the ICH M11 Protocol standard, Rationale for Estimand(s).	ICH M11 Protocol Section 4.2.1 Rationale for Estimand(s)
	4.2.2 Rationale for Intervention Model		C218538		Section 4.2.2 of the ICH M11 Protocol standard, Rationale for Intervention Model.	ICH M11 Protocol Section 4.2.2 Rationale for Intervention Model
	4.2.3 Rationale for Control Type		C218539		Section 4.2.3 of the ICH M11 Protocol standard, Rationale for Control Type.	ICH M11 Protocol Section 4.2.3 Rationale for Control Type
	4.2.4 Rationale for Trial Duration		C218540		Section 4.2.4 of the ICH M11 Protocol standard, Rationale for Trial Duration.	ICH M11 Protocol Section 4.2.4 Rationale for Trial Duration
	4.2.5 Rationale for Adaptive or Novel Trial Design		C218541		Section 4.2.5 of the ICH M11 Protocol standard, Rationale for Adaptive or Novel Trial Design.	ICH M11 Protocol Section 4.2.5 Rationale for Adaptive or Novel Trial Design
	4.2.6 Rationale for Interim Analysis		C218542		Section 4.2.6 of the ICH M11 Protocol standard, Rationale for Interim Analysis.	ICH M11 Protocol Section 4.2.6 Rationale for Interim Analysis
	4.2.7 Rationale for Other Trial Design Aspects		C218543		Section 4.2.7 of the ICH M11 Protocol standard, Rationale for Other Trial Design Aspects.	ICH M11 Protocol Section 4.2.7 Rationale for Other Trial Design Aspects
	4.3 Trial Stopping Rules		C218544		Section 4.3 of the ICH M11 Protocol standard, Trial Stopping Rules.	ICH M11 Protocol Section 4.3 Trial Stopping Rules
	4.4 Start of Trial and End of Trial		C218545		Section 4.4 of the ICH M11 Protocol standard, Start of Trial and End of Trial.	ICH M11 Protocol Section 4.4 Start of Trial and End of Trial
	4.5 Access to Trial Intervention After End of Trial		C218546		Section 4.5 of the ICH M11 Protocol standard, Access to Trial Intervention After End of Trial.	ICH M11 Protocol Section 4.5 Access to Trial Intervention After End of Trial
	5 TRIAL POPULATION		C218547		Section 5 of the ICH M11 Protocol standard, TRIAL POPULATION.	ICH M11 Protocol Section 5 TRIAL POPULATION
	5.1 Description of Trial Population and Rationale		C218548		Section 5.1 of the ICH M11 Protocol standard, Description of Trial Population and Rationale.	ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale
	5.2 Inclusion Criteria		C218549		Section 5.2 of the ICH M11 Protocol standard, Inclusion Criteria.	ICH M11 Protocol Section 5.2 Inclusion Criteria
	5.3 Exclusion Criteria		C218550		Section 5.3 of the ICH M11 Protocol standard, Exclusion Criteria.	ICH M11 Protocol Section 5.3 Exclusion Criteria
	5.4 Contraception		C218551		Section 5.4 of the ICH M11 Protocol standard, Contraception.	ICH M11 Protocol Section 5.4 Contraception
	5.4.1 Definitions Related to Childbearing Potential		C218552		Section 5.4.1 of the ICH M11 Protocol standard, Definitions Related to Childbearing Potential.	ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential
	5.4.2 Contraception Requirements		C218553		Section 5.4.2 of the ICH M11 Protocol standard, Contraception Requirements.	ICH M11 Protocol Section 5.4.2 Contraception Requirements
	5.5 Lifestyle Restrictions		C218554		Section 5.5 of the ICH M11 Protocol standard, Lifestyle Restrictions.	ICH M11 Protocol Section 5.5 Lifestyle Restrictions
	5.5.1 Meals and Dietary Restrictions		C218555		Section 5.5.1 of the ICH M11 Protocol standard, Meals and Dietary Restrictions.	ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions
	5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions		C218556		Section 5.5.2 of the ICH M11 Protocol standard, Caffeine, Alcohol, Tobacco, and Other Restrictions.	ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions
	5.5.3 Physical Activity Restrictions		C218557		Section 5.5.3 of the ICH M11 Protocol standard, Physical Activity Restrictions.	ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions
	5.5.4 Other Activity Restrictions		C218558		Section 5.5.4 of the ICH M11 Protocol standard, Other Activity Restrictions.	ICH M11 Protocol Section 5.5.4 Other Activity Restrictions
	5.6 Screen Failure and Rescreening		C218559		Section 5.6 of the ICH M11 Protocol standard, Screen Failure and Rescreening.	ICH M11 Protocol Section 5.6 Screen Failure and Rescreening
	6 TRIAL INTERVENTION AND CONCOMITANT THERAPY		C218560		Section 6 of the ICH M11 Protocol standard, TRIAL INTERVENTION AND CONCOMITANT THERAPY.	ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY
	6.1 Description of Investigational Trial Intervention		C218561		Section 6.1 of the ICH M11 Protocol standard, Description of Investigational Trial Intervention.	ICH M11 Protocol Section 6.1 Description of Investigational Trial Intervention
	6.10 Concomitant Therapy		C218580		Section 6.10 of the ICH M10 Protocol standard, Concomitant Therapy.	ICH M11 Protocol Section 6.10 Concomitant Therapy
	6.10.1 Prohibited Concomitant Therapy		C218581		Section 6.10.1 of the ICH M10 Protocol standard, Prohibited Concomitant Therapy.	ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy
	6.10.2 Permitted Concomitant Therapy		C218582		Section 6.10.2 of the ICH M10 Protocol standard, Permitted Concomitant Therapy.	ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy
	6.2 Rationale for Investigational Trial Intervention Dose and Regimen		C218562		Section 6.2 of the ICH M11 Protocol standard, Rationale for Investigational Trial Intervention Dose and Regimen.	ICH M11 Protocol Section 6.2 Rationale for Investigational Trial Intervention Dose and Regimen
	6.3 Investigational Trial Intervention Administration		C218563		Section 6.3 of the ICH M11 Protocol standard, Investigational Trial Intervention Administration.	ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration
	6.4 Investigational Trial Intervention Dose Modification		C218564		Section 6.4 of the ICH M11 Protocol standard, Investigational Trial Intervention Dose Modification.	ICH M11 Protocol Section 6.4 Investigational Trial Intervention Dose Modification
	6.5 Management of Investigational Trial Intervention Overdose		C218565		Section 6.5 of the ICH M11 Protocol standard, Management of Investigational Trial Intervention Overdose.	ICH M11 Protocol Section 6.5 Management of Investigational Trial Intervention Overdose
	6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention		C218566		Section 6.6 of the ICH M11 Protocol standard, Preparation, Storage, Handling and Accountability of Investigational Trial Intervention.	ICH M11 Protocol Section 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention
	6.6.1 Preparation of Investigational Trial Intervention		C218567		Section 6.6.1 of the ICH M11 Protocol standard, Preparation of Investigational Trial Intervention.	ICH M11 Protocol Section 6.6.1 Preparation of Investigational Trial Intervention
	6.6.2 Storage and Handling of Investigational Trial Intervention		C218568		Section 6.6.2 of the ICH M11 Protocol standard, Storage and Handling of Investigational Trial Intervention.	ICH M11 Protocol Section 6.6.2 Storage and Handling of Investigational Trial Intervention
	6.6.3 Accountability of Investigational Trial Intervention		C218569		Section 6.6.3 of the ICH M11 Protocol standard, Accountability of Investigational Trial Intervention.	ICH M11 Protocol Section 6.6.3 Accountability of Investigational Trial Intervention
	6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding		C218570		Section 6.7 of the ICH M11 Protocol standard, Investigational Trial Intervention Assignment, Randomisation and Blinding.	ICH M11 Protocol Section 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding
	6.7.1 Participant Assignment to Investigational Trial Intervention		C218571		Section 6.7.1 of the ICH M11 Protocol standard, Participant Assignment to Investigational Trial Intervention.	ICH M11 Protocol Section 6.7.1 Participant Assignment to Investigational Trial Intervention
	6.7.2 Randomisation		C218572		Section 6.7.2 of the ICH M11 Protocol standard, Randomisation.	ICH M11 Protocol Section 6.7.2 Randomisation
	6.7.3 Measures to Maintain Blinding		C218573		Section 6.7.3 of the ICH M11 Protocol standard, Measures to Maintain Blinding.	ICH M11 Protocol Section 6.7.3 Measures to Maintain Blinding
	6.7.4 Emergency Unblinding at the Site		C218574		Section 6.7.4 of the ICH M11 Protocol standard, Emergency Unblinding at the Site.	ICH M11 Protocol Section 6.7.4 Emergency Unblinding at the Site
	6.8 Investigational Trial Intervention Adherence		C218575		Section 6.8 of the ICH M11 Protocol standard, Investigational Trial Intervention Adherence.	ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence
	6.9 Description of Noninvestigational Trial Intervention		C218576		Section 6.9 of the ICH M11 Protocol standard, Description of Noninvestigational Trial Intervention.	ICH M11 Protocol Section 6.9 Description of Noninvestigational Trial Intervention
	6.9.1 Background Trial Intervention		C218577		Section 6.9.1 of the ICH M11 Protocol standard, Background Trial Intervention.	ICH M11 Protocol Section 6.9.1 Background Trial Intervention
	6.9.2 Rescue Therapy		C218578		Section 6.9.2 of the ICH M11 Protocol standard, Rescue Therapy.	ICH M11 Protocol Section 6.9.2 Rescue Therapy
	6.9.3 Other Noninvestigational Trial Intervention		C218579		Section 6.9.3 of the ICH M11 Protocol standard, Other Noninvestigational Trial Intervention.	ICH M11 Protocol Section 6.9.3 Other Noninvestigational Trial Intervention
	7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL		C218583		Section 7 of the ICH M11 Protocol standard, PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL.	ICH M11 Protocol Section 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL
	7.1 Discontinuation of Trial Intervention for Individual Participants		C218584		Section 7.1 of the ICH M11 Protocol standard, Discontinuation of Trial Intervention for Individual Participants.	ICH M11 Protocol Section 7.1 Discontinuation of Trial Intervention for Individual Participants
	7.1.1 Permanent Discontinuation of Trial Intervention		C218585		Section 7.1.1 of the ICH M11 Protocol standard, Permanent Discontinuation of Trial Intervention.	ICH M11 Protocol Section 7.1.1 Permanent Discontinuation of Trial Intervention
	7.1.2 Temporary Discontinuation of Trial Intervention		C218586		Section 7.1.2 of the ICH M11 Protocol standard, Temporary Discontinuation of Trial Intervention.	ICH M11 Protocol Section 7.1.2 Temporary Discontinuation of Trial Intervention
	7.1.3 Rechallenge		C218587		Section 7.1.3 of the ICH M11 Protocol standard, Rechallenge.	ICH M11 Protocol Section 7.1.3 Rechallenge
	7.2 Participant Discontinuation or Withdrawal from the Trial		C218588		Section 7.2 of the ICH M11 Protocol standard, Participant Discontinuation or Withdrawal from the Trial.	ICH M11 Protocol Section 7.2 Participant Discontinuation or Withdrawal from the Trial
	7.3 Management of Loss to Follow-Up		C218589		Section 7.3 of the ICH M11 Protocol standard, Management of Loss to Follow-Up.	ICH M11 Protocol Section 7.3 Management of Loss to Follow-Up
	8 TRIAL ASSESSMENTS AND PROCEDURES		C218590		Section 8 of the ICH M11 Protocol standard, TRIAL ASSESSMENTS AND PROCEDURES.	ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
	8.1 Trial Assessments and Procedures Considerations		C218591		Section 8.1 of the ICH M11 Protocol standard, Trial Assessments and Procedures Considerations.	ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations
	8.2 Screening/Baseline Assessments and Procedures		C218592		Section 8.2 of the ICH M11 Protocol standard, Screening/Baseline Assessments and Procedures.	ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures
	8.3 Efficacy Assessments and Procedures		C218593		Section 8.3 of the ICH M11 Protocol standard, Efficacy Assessments and Procedures.	ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures
	8.4 Safety Assessments and Procedures		C218594		Section 8.4 of the ICH M11 Protocol standard, Safety Assessments and Procedures.	ICH M11 Protocol Section 8.4 Safety Assessments and Procedures
	8.4.1 Physical Examination		C218595		Section 8.4.1 of the ICH M11 Protocol standard, Physical Examination.	ICH M11 Protocol Section 8.4.1 Physical Examination
	8.4.2 Vital Signs		C218596		Section 8.4.2 of the ICH M11 Protocol standard, Vital Signs.	ICH M11 Protocol Section 8.4.2 Vital Signs
	8.4.3 Electrocardiograms		C218597		Section 8.4.3 of the ICH M11 Protocol standard, Electrocardiograms.	ICH M11 Protocol Section 8.4.3 Electrocardiograms
	8.4.4 Clinical Laboratory Assessments		C218598		Section 8.4.4 of the ICH M11 Protocol standard, Clinical Laboratory Assessments.	ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments
	8.4.5 Pregnancy Testing		C218599		Section 8.4.5 of the ICH M11 Protocol standard, Pregnancy Testing.	ICH M11 Protocol Section 8.4.5 Pregnancy Testing
	8.4.6 Suicidal Ideation and Behaviour Risk Monitoring		C218600		Section 8.4.6 of the ICH M11 Protocol standard, Suicidal Ideation and Behaviour Risk Monitoring.	ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring
	8.5 Pharmacokinetics		C218601		Section 8.5 of the ICH M11 Protocol standard, Pharmacokinetics.	ICH M11 Protocol Section 8.5 Pharmacokinetics
	8.6 Biomarkers		C218602		Section 8.6 of the ICH M11 Protocol standard, Biomarkers.	ICH M11 Protocol Section 8.6 Biomarkers
	8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics		C218603		Section 8.6.1 of the ICH M11 Protocol standard, Genetics, Genomics, Pharmacogenetics and Pharmacogenomics.	ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics
	8.6.2 Pharmacodynamic Biomarkers		C218604		Section 8.6.2 of the ICH M11 Protocol standard, Pharmacodynamic Biomarkers.	ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers
	8.6.3 Other Biomarkers		C218605		Section 8.6.3 of the ICH M11 Protocol standard, Other Biomarkers.	ICH M11 Protocol Section 8.6.3 Other Biomarkers
	8.7 Immunogenicity Assessments		C218606		Section 8.7 of the ICH M11 Protocol standard, Immunogenicity Assessments.	ICH M11 Protocol Section 8.7 Immunogenicity Assessments
	8.8 Medical Resource Utilisation and Health Economics		C218607		Section 8.8 of the ICH M11 Protocol standard, Medical Resource Utilisation and Health Economics.	ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics
	9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS		C218608		Section 9 of the ICH M11 Protocol standard, ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS.	ICH M11 Protocol Section 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS
	9.1 Definitions		C218609		Section 9.1 of the ICH M11 Protocol standard, Definitions.	ICH M11 Protocol Section 9.1 Definitions
	9.1.1 Definitions of Adverse Events		C218610		Section 9.1.1 of the ICH M11 Protocol standard, Definitions of Adverse Events.	ICH M11 Protocol Section 9.1.1 Definitions of Adverse Events
	9.1.2 Definitions of Serious Adverse Events		C218611		Section 9.1.2 of the ICH M11 Protocol standard, Definitions of Serious Adverse Events.	ICH M11 Protocol Section 9.1.2 Definitions of Serious Adverse Events
	9.1.3 Definitions of Product Complaints		C218612		Section 9.1.3 of the ICH M11 Protocol standard, Definitions of Product Complaints.	ICH M11 Protocol Section 9.1.3 Definitions of Product Complaints
	9.1.3.1 Definitions of Medical Device Product Complaints		C218613		Section 9.1.3.1 of the ICH M11 Protocol standard, Definitions of Medical Device Product Complaints.	ICH M11 Protocol Section 9.1.3.1 Definitions of Medical Device Product Complaints
	9.2 Timing and Procedures for Collection and Reporting		C218614		Section 9.2 of the ICH M11 Protocol standard, Timing and Procedures for Collection and Reporting.	ICH M11 Protocol Section 9.2 Timing and Procedures for Collection and Reporting
	9.2.1 Timing		C218615		Section 9.2.1 of the ICH M11 Protocol standard, Timing.	ICH M11 Protocol Section 9.2.1 Timing
	9.2.2 Collection Procedures		C218616		Section 9.2.2 of the ICH M11 Protocol standard, Collection Procedures.	ICH M11 Protocol Section 9.2.2 Collection Procedures
	9.2.3 Reporting		C218617		Section 9.2.3 of the ICH M11 Protocol standard, Reporting.	ICH M11 Protocol Section 9.2.3 Reporting
	9.2.3.1 Regulatory Reporting Requirements		C218618		Section 9.2.3.1 of the ICH M11 Protocol standard, Regulatory Reporting Requirements.	ICH M11 Protocol Section 9.2.3.1 Regulatory Reporting Requirements
	9.2.4 Adverse Events of Special Interest		C218619		Section 9.2.4 of the ICH M11 Protocol standard, Adverse Events of Special Interest.	ICH M11 Protocol Section 9.2.4 Adverse Events of Special Interest
	9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs		C218620		Section 9.2.5 of the ICH M11 Protocol standard, Disease-related Events or Outcomes Not Qualifying as AEs or SAEs.	ICH M11 Protocol Section 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
	9.3 Pregnancy and Postpartum Information		C218621		Section 9.3 of the ICH M11 Protocol standard, Pregnancy and Postpartum Information.	ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information
	9.3.1 Participants Who Become Pregnant During the Trial		C218622		Section 9.3.1 of the ICH M11 Protocol standard, Participants Who Become Pregnant During the Trial.	ICH M11 Protocol Section 9.3.1 Participants Who Become Pregnant During the Trial
	9.3.2 Participants Whose Partners Become Pregnant During the Trial		C218623		Section 9.3.2 of the ICH M11 Protocol standard, Participants Whose Partners Become Pregnant During the Trial.	ICH M11 Protocol Section 9.3.2 Participants Whose Partners Become Pregnant During the Trial
	9.4 Special Safety Situations		C218624		Section 9.4 of the ICH M11 Protocol standard, Special Safety Situations.	ICH M11 Protocol Section 9.4 Special Safety Situations
	Amendment Details		C222770		Amendment Details Section of the ICH M11 Protocol standard, Amendment Details.	ICH M11 Protocol Section Amendment Details
	Title Page		C222769		Title Page Section of the ICH M11 Protocol standard, Title Page.	ICH M11 Protocol Section Title Page
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CL.C217276.Reason for Amendment Response Terminology	Reason for Amendment Response Terminology (Reason for Amendment Response Terminology)	text Extensible: No	C217276	Reason for Amendment Response Terminology	A valid value set relevant to the reason for amendment responses within the ICH M11 protocol template.	ICH M11 Reason for Amendment Value Set Terminology
	Change In Standard Of Care		C218497		A change in the standard of care necessitates a change(s) to, or formal clarification of, the protocol.	Change in Standard Of Care Amendment Reason
	Change In Strategy		C218496		A change in the study purpose or intent of the scientific plan necessitates a change(s) to, or formal clarification of, the protocol.	Change in Strategy Amendment Reason
	IMP Addition		C218495		The addition of an investigational medicinal product to a clinical trial design necessitates a change(s) to, or formal clarification of, the protocol.	IMP Addition Amendment Reason
	Inconsistency And/Or Error In The Protocol		C218501		An error or inconsistency in the protocol necessitates a change(s) to, or formal clarification of, the protocol.	Inconsistency and/or Error in the Protocol Amendment Reason
	Investigator/Site Feedback		C218499		Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol.	Investigator/Site Feedback Amendment Reason
	IRB/IEC Feedback		C218492		Feedback from the institutional review board or independent ethics committee necessitates a change(s) to, or formal clarification of, the protocol.	IRB/IEC Feedback Amendment Reason
	Manufacturing Change		C218494		A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol.	Manufacturing Change Amendment Reason
	New Data Available (Other Than Safety Data)		C218498		Previously unavailable data (other than safety data) becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.	New Data Available (Other Than Safety Data) Amendment Reason
	New Regulatory Guidance		C218491		A regulatory agency has published a guidance document that necessitates a change(s) to, or formal clarification of, the protocol.	New Regulatory Guidance Amendment Reason
	New Safety Information Available		C218493		Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.	New Safety Information Available Amendment Reason
	Not Applicable		C48660		Determination of a value is not relevant in the current context.	Not Applicable
	Other		C17649		Different than the one(s) previously specified or mentioned.	Other
	Protocol Design Error		C218502		A protocol design error necessitates a change(s) to, or formal clarification of, a document.	Protocol Design Error Amendment Reason
	Recruitment Difficulty		C218500		Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol.	Recruitment Difficulty Amendment Reason
	Regulatory Agency Request To Amend		C218490		A regulatory agency has expressed a need for a change(s) to, or formal clarification of, the protocol.	Regulatory Agency Request to Amend Amendment Reason
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CL.C217283.Trial Arm Type Response Terminology	Trial Arm Type Response Terminology (Trial Arm Type Response Terminology)	text Extensible: No	C217283	Trial Arm Type Response Terminology	A valid value set relevant to the trial arm type responses within the ICH M11 protocol template.	ICH M11 Trial Arm Type Value Set Terminology
	Active Comparator Arm		C174267		An arm describing the active comparator.	Active Comparator Arm
	Control Arm		C174226		An arm describing the intervention or treatment plan for a group of participants in the study receiving a control. The control may comprise a non-investigational product (active control) or regimen, placebo, or no treatment.	Control Arm
	Experimental Arm		C174266		An arm describing the intervention or treatment plan for a group of participants in the study receiving test product(s).	Investigational Arm
	No Intervention Arm		C174270		A study arm without an intervention or treatment.	No Intervention Arm
	Placebo Comparator Arm		C174268		An arm describing the placebo comparator.	Placebo Control Arm
	Sham Comparator Arm		C174269		An arm describing the sham comparator.	Sham Comparator Arm
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CL.C217281.Trial Blinding Role Response Terminology	Trial Blinding Role Response Terminology (Trial Blinding Role Response Terminology)	text Extensible: No	C217281	Trial Blinding Role Response Terminology	A valid value set relevant to the trial blinding role responses within the ICH M11 protocol template.	ICH M11 Trial Blinding Role Value Set Terminology
	Care Provider		C17445		The primary person in charge of the care of a patient, usually a family member or a designated health care professional.	Caregiver
	Investigator		C25936		A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at the trial site, the investigator is the responsible leader of the team and may be called the principal investigator.	Investigator
	Not Applicable		C48660		Determination of a value is not relevant in the current context.	Not Applicable
	Outcomes Assessor		C207599		The individual who evaluates the outcome(s) of interest.	Outcomes Assessor
	Participant		C142710		A member of the clinical study population from whom data are being collected. (CDISC Glossary)	Study Participant
	Sponsor		C70793		An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. (CDISC Glossary)	Clinical Study Sponsor
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CL.C217051.Trial Blinding Schema Response Terminology	Trial Blinding Schema Response Terminology (Trial Blinding Schema Response Terminology)	text Extensible: No	C217051	Trial Blinding Schema Response Terminology	Terminology associated with the trial blind schema value set codelist of the ICH M11 protocol template.	ICH M11 Trial Blind Schema Value Set Terminology
	Double Blind		C15228		A study in which neither the participant nor the study personnel interacting with the participant or data during the study knows what intervention a participant is receiving.	Double Blind Study
	Observer Blind		C187674		A study in which the study personnel who measure, record, or assess the participant do not know which intervention the participant is receiving or, in the context of observational studies, do not know the external factors to which a participant has been exposed.	Observer Blind Study
	Open Label		C49659		A study in which participants and study personnel know which intervention each participant is receiving.	Open Label Study
	Single Blind		C28233		A study in which one party, either the participant or study personnel, does not know which intervention is administered to the participant.	Single Blind Study
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CL.C217280.Trial Intervention Assignment Method Response Terminology	Trial Intervention Assignment Method Response Terminology (Trial Intervention Assignment Method Response Terminology)	text Extensible: No	C217280	Trial Intervention Assignment Method Response Terminology	A valid value set relevant to the trial intervention assignment method responses within the ICH M11 protocol template.	ICH M11 Trial Intervention Assignment Method Value Set Terminology
	No Intervention Assignment Method		C222801		No specific methodology is used to assign trial participants to treatment or control groups.	No Intervention Assignment Method
	Other		C17649		Different than the one(s) previously specified or mentioned.	Other
	Randomisation		C25196		The process of assigning trial participants to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (CDISC Glossary)	Randomization
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CL.C217045.Trial Phase Response Terminology	Trial Phase Response Terminology (Trial Phase Response Terminology)	text Extensible: No	C217045	Trial Phase Response Terminology	Terminology associated with the trial phase value set codelist of the ICH M11 protocol template.	ICH M11 Trial Phase Value Set Terminology
	Early Phase 1		C54721		Exploratory clinical trials, in a small number of participants, that are conducted early in Phase 1. The investigational trial intervention is administered at a low dose for a limited time. Early Phase 1 trials provide insights into a variety of parameters such as pharmacokinetic, pharmacodynamic, and other biomarkers. They involve limited human exposure, have no therapeutic or diagnostic intent, and are not intended to assess clinical tolerability.	Early Phase 1 Trial
	Phase 1		C15600		Exploratory clinical trials that may be first-in-human, conducted in a small number of patients or healthy volunteers to evaluate clinical safety, tolerability, or therapeutic intent (pharmacokinetics and pharmacodynamics) of an investigational trial intervention.	Phase I Trial
	Phase 1/Phase 2		C15693		A single clinical trial that combines elements of Phase 1 and Phase 2 trials, which may begin as a Phase 1 trial and transition into Phase 2 based upon predetermined criteria.	Phase I/II Trial
	Phase 1/Phase 2/Phase 3		C198366		A single clinical trial that combines elements of Phase 1, Phase 2, and Phase 3 trials, which may begin as a Phase 1 trial and transitions through Phase 2 and Phase 3 based upon predetermined criteria.	Phase I/II/III Trial
	Phase 1/Phase 3		C198367		A single clinical trial that combines elements of Phase 1 and Phase 3 trials, which may begin as a Phase 1 trial and transition into Phase 3 based upon predetermined criteria.	Phase I/III Trial
	Phase 2		C15601		Exploratory trials conducted to evaluate the safety and efficacy of the investigational trial intervention in patients with the disease or condition. Objectives may include, but are not limited to, clinical pharmacology, dose-ranging (dose-response, frequency of dosing), type of patients, or other characteristics of safety and efficacy.	Phase II Trial
	Phase 2/Phase 3		C15694		A single clinical trial that combines elements of Phase 2 and Phase 3 trials, which may begin as a Phase 2 trial and transition into Phase 3 based upon predetermined criteria.	Phase II/III Trial
	Phase 2/Phase 3/Phase 4		C217024		A single clinical trial that combines elements of Phase 2, Phase 3, and Phase 4 trials, which may begin as a Phase 2 trial and transitions through Phase 3 and Phase 4 based upon predetermined criteria.	Phase II/III/IV Trial
	Phase 3		C15602		Confirmatory trials conducted to demonstrate safety, efficacy and tolerability of the investigational trial intervention in patients with the disease or condition. Their objectives are to evaluate the overall benefit-risk relationship and may provide substantial evidence for regulatory approval and product information.	Phase III Trial
	Phase 3/Phase 4		C217025		A single clinical trial that combines elements of Phase 3 and Phase 4 trials, which may begin as a Phase 3 trial and transition into Phase 4 based upon predetermined criteria.	Phase III/IV Trial
	Phase 4		C15603		Post-approval (or post-marketing) trials conducted to further evaluate the safety and efficacy of an investigational trial intervention in its approved indication and may be conducted to address a regulatory requirement. These studies may explore use of the investigational trial intervention in the real-world setting of clinical practice and may also inform health economics and health technology assessments.	Phase IV Trial
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CL.C217049.Trial Site Distribution Response Terminology	Trial Site Distribution Response Terminology (Trial Site Distribution Response Terminology)	text Extensible: No	C217049	Trial Site Distribution Response Terminology	Terminology associated with the site distribution value set codelist of the ICH M11 protocol template.	ICH M11 Trial Site Distribution Value Set Terminology
	Multicentre		C217005		A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.	Multicenter Study
	Single-Centre		C217004		A clinical trial that is conducted at a single site.	Single-Center Study
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CL.C217050.Trial Site Geographic Scope Response Terminology	Trial Site Geographic Scope Response Terminology (Trial Site Geographic Scope Response Terminology)	text Extensible: No	C217050	Trial Site Geographic Scope Response Terminology	Terminology associated with the site geographic scope value set codelist of the ICH M11 protocol template.	ICH M11 Trial Site Geographic Scope Value Set Terminology
	Multiple Countries		C217007		Of, or pertaining to, an occurrence in more than one country.	Multiple Countries
	Single Country		C217006		Of, or pertaining to, an occurrence in one country.	Single Country
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CL.C217287.Trial-Related Safety Event Type Response Terminology	Trial-Related Safety Event Type Response Terminology (Trial-Related Safety Event Type Response Terminology)	text Extensible: No	C217287	Trial-Related Safety Event Type Response Terminology	A valid value set relevant to the trial-related safety event type responses within the ICH M11 protocol template.	ICH M11 Trial-Related Safety Event Type Value Set Terminology
	Adverse Event		C41331		Any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.	Adverse Event
	Drug/Device Combination Product Complaint		C222331		Any concern about the safety, quality, and/or performance of a trial-related drug-device combination.	Drug-Device Combination Product Complaint
	Lactation Event		C218510		Any event that occurs when the participant is lactating.	Lactation Event
	Not Reportable Adverse Event of Special Interest		C218513		An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate, and which is deemed to be not reportable to the appropriate regulatory authority.	Not Reportable Adverse Event of Special Interest
	Other		C17649		Different than the one(s) previously specified or mentioned.	Other
	Post-Partum Event		C218511		Any event that occurs when the participant is in the stages of recovery post pregnancy and birth event.	Post-Partum Event
	Pregnancy Event		C218509		Any event that occurs when the participant or participant's partner becomes pregnant or is pregnant.	Pregnancy Event
	Reportable Adverse Event of Special Interest		C218512		An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate, and which is deemed to be reportable to the appropriate regulatory authority.	Reportable Adverse Event of Special Interest
	Serious Adverse Event		C41335		Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or any other medically significant event that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the definition.	Serious Adverse Event
	Trial Intervention Complaint		C218508		Any concern about the safety and/or quality of any trial-related interventions.	Trial Intervention Complaint
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CL.C217048.Unit of Measure Terminology	Unit of Measure Terminology (Unit of Measure Terminology)	text Extensible: No	C217048	Unit of Measure Terminology	Terminology associated with the units of measure value set codelist of the ICH M11 protocol template.	ICH M11 Units of Measure Value Set Terminology
	Days		C25301		A unit of measurement of time equal to 24 hours.	Day
	Hours		C25529		A unit of measurement of time equal to 60 minutes.	Hour
	Months		C29846		One of the 12 divisions of a year as determined by a calendar. It corresponds to the unit of time of approximately to one cycle of the moon's phases, about 30 days or 4 weeks.	Month
	Weeks		C29844		Any period of seven consecutive days.	Week
	Years		C29848		The period of time that it takes for Earth to make a complete revolution around the sun, approximately 365 days; a specific one year period.	Year
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