ICH M11 Controlled Terminology ICH M11 Controlled Terminology, 2025-12-19 ICH M11 Controlled Terminology A valid value set relevant to the amendment details statement responses within the ICH M11 protocol template. 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). 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. Protocol Previously Amended See Summary of Changes Before the Table of Contents This protocol has not been amended. Protocol Not Amended Amendment Details Statement Response Terminology Amendment Details Statement Response Terminology ICH M11 Amendment Details Statement Value Set Terminology A valid value set relevant to the amendment scope enrollment description responses within the ICH M11 protocol template. Covering or affecting a cohort of individuals. By Cohort Covering or affecting the whole of a system. Global Covering or affecting a portion of the system. Locally Amendment Scope Enrollment Description Response Terminology Amendment Scope Enrollment Description Response Terminology ICH M11 Amendment Scope Enrollment Description Value Set Terminology Terminology associated with the amendment scope value set codelist of the ICH M11 protocol template. Covering or affecting the whole of a system. Global Covering or affecting a portion of the system. Not Global Amendment Scope Response Terminology Amendment Scope Response Terminology ICH M11 Amendment Scope Value Set Terminology A valid value set relevant to the control type responses within the ICH M11 protocol template. A type of control, which has a demonstrated effect, administered as a comparator to participants in a clinical trial. Active Control 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 A type of control using different doses or regimens of the same treatment across the treatment arms. Dose Response Control 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 A clinical study that lacks a comparison (i.e., a control) group. Uncontrolled Study An inactive, identical-appearing drug or treatment that does not contain the test product. Placebo Control 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 Control Type Response Terminology Control Type Response Terminology ICH M11 Control Type Value Set Terminology Terminology relevant to the data elements in section 1 of the ICH M11 protocol template. An indication as to whether the clinical trial uses an adaptive trial design. Adaptive Trial Design Indicator 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 An alternative textual narrative for the planned duration of trial intervention. Alternate Description of Planned Duration of Trial Intervention An alternative narrative for the planned duration of trial participation. Alternate Description of Planned Duration of Trial Participation An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function. Blinding Role A characterisation or classification of the comparator against which the study intervention is evaluated. Control Type An indication as to whether the clinical trial is testing a drug-device combination product. Drug/Device Combination Product Indicator An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities. Independent Oversight Committee A unique name that is globally recognised and public property, which identifies pharmaceutical substances or active pharmaceutical ingredients. International Nonproprietary Name The technique used to assign trial participants to a trial intervention or trial arm. Intervention Assignment Method The overall design configuration for assigning intervention to participants. Intervention Model An indication as to whether the protocol is a master protocol. Master Protocol Indicator The anticipated maximum age of the participants to be entered in a clinical trial. Planned Maximum Age of Subjects The anticipated minimum age of the participants to be entered in a clinical trial. Planned Minimum Age of Subjects Drug name that is not protected by a trademark, usually descriptive of its chemical structure, and sometimes a public name. Generic Name The planned number of intervention groups. Planned Number of Arms The planned number of participants to be entered in a clinical trial. Planned Subject Number A committee that is different than the one(s) previously specified or mentioned. Other Committee Description of any intervention assignment method that is different than the one(s) previously specified or mentioned. Other Intervention Assignment Method A description of the condition, disease or disorder that the clinical trial is intended to investigate or address. Trial Indication A characterisation or classification of the trial population. Population Type A descriptive summary of the primary and secondary objectives and their associated estimands related to the trial. Primary and Secondary Objectives and Estimands Summary A characterisation or classification of the randomisation used to assign trial participants to treatment or control groups. Randomization Type 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 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 A brief written record describing the trial schematic. Trial Schematic Note An indication as to whether the occurrence applies to a single or multiple trial sites. Site Distribution Indicator An indication as to whether the trial is taking place in one or more countries. Site Geographic Scope Indicator An indication as to whether stratification is used as part of the randomisation process. Stratification Indicator 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 The unit of time associated with the numeric value for the planned duration of trial intervention. Planned Duration of Trial Intervention Unit of Time The numeric value for the planned duration of trial intervention. Planned Duration of Trial Intervention The unit of time associated with the numeric value for the planned duration of trial participation. Planned Duration of Trial Participation Unit of Time The numeric value for the planned duration of trial participation. Planned Duration of Trial Participation 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 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 Those units of time that are routinely used to express the age of a person. Age Unit ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology ICH M11 Protocol Section 1 Data Element Terminology Terminology relevant to the data elements in section 10 of the ICH M11 protocol template. A description of the statistical model, hypothesis, and methods of analyses for each exploratory objective within the trial. Exploratory Objective Statistical Analysis Method A description of analyses relevant to variables at baseline, for example demographics, related to the trial. Description of Trial Baseline Variable Analysis A description of the set of participants whose data are to be included in the analyses. Description of the Participants Included in Data Analysis Careful thought or deliberation related to the planned conduct of statistical analyses within the context of the trial. General Statistical Consideration 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) 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) 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) 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) 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 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 A description of the analyses that are different than the one(s) previously specified or mentioned. Other Analysis A description of the analyses of relevant safety variables, including adverse events of special interest. Safety Analysis 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 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 A description of the statistical model, hypothesis, and methods of analyses for each objective within the trial. Trial-Related Statistical Analysis Method 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 ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology ICH M11 Protocol Section 10 Data Element Terminology Terminology relevant to the data elements in section 11 of the ICH M11 protocol template. A description of the type and administrative structure of any committee associated with the trial. Committee Description The requirements that must be met in order to close a trial site prematurely. Criteria for Early Trial Site Closure A description of whether and which public databases the clinical trial, and results if applicable, will be registered. Study Data Dissemination 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 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 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 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 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 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 A description of how trial-related source records will be identified. Identification of Source Records Description A description of the consent requirements for participants in the event of screen failure and rescreening. Informed Consent Requirements for Rescreening 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 A concise summary of the arrangements for participants insurance and indemnity as required by the applicable regulatory body. Insurance and Indemnity Summary A description of the obligations of the investigator with respect to maintaining and ensuring availability of the source records. Investigator Expectations for Source Records A description of the obligations of the investigator with respect to the trial. Investigator Responsibilities A description of plans for detecting, reviewing, and reporting any deviations from the protocol. Protocol Deviation Management Careful thought or deliberation related to the regulatory and ethical aspects of the trial. Trial Regulatory and Ethical Consideration 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 A description of how potential risks and critical to quality factors associated with the trial will be identified and handled. Risk-Based Quality Management A description of trial-related source records including the importance of source record maintenance and expectations for data traceability. Trial-Related Source Records Description A description of the obligations of the sponsor with respect to the trial. Sponsor Responsibilities 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 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 ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology ICH M11 Protocol Section 11 Data Element Terminology Terminology relevant to the data elements in section 12 of the ICH M11 protocol template. Extra or supplementary appendices added to the end of a document. Additional Document Appendices A sequence of characters used to uniquely identify a protocol amendment. Amendment Identifier The enrollment description as to whether the amendment scope applies globally, locally, or per cohort across the trial. Amendment Scope Enrollment Description 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 The brief reason for the change introduced in the current or prior version of the protocol. Brief Rationale for Protocol Change Any procedure that involves testing or manipulating a sample of blood, urine, or other body substance in a laboratory setting. Laboratory Procedure A sequence of characters used to identify and/or name a country or region. Country and/or Region Identifier A description of any country or region-specific clarifications related to a protocol item. Country and/or Region-Specific Protocol Clarifications Description 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 A description of the change introduced in the current or prior version of the protocol. Description of Protocol Change 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 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 The physical or virtual location of the overview of changes from each prior amendment. Alternative Location of Protocol Changes The date that the sponsor approved a version of the protocol. Protocol Approval by Sponsor Date ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology ICH M11 Protocol Section 12 Data Element Terminology Terminology relevant to the data elements in section 13 of the ICH M11 protocol template. A list of terms with their abbreviations and/or definitions. Glossary of Terms and Abbreviations ICH M11 Section 13 Terminology ICH M11 Section 13 Terminology ICH M11 Protocol Section 13 Data Element Terminology Terminology relevant to the data elements in section 14 of the ICH M11 protocol template. The curated list of sources that are cited within the reference section of the document. Reference List ICH M11 Section 14 Terminology ICH M11 Section 14 Terminology ICH M11 Protocol Section 14 Data Element Terminology Terminology relevant to the data elements in section 2 of the ICH M11 protocol template. A short textual description containing the potential physical, psychological, social, legal, and other benefits to the trial participant. Trial Participant Benefit Summary A short textual description containing the risks and benefits associated with participation in the trial. Overall Risk-Benefit Assessment Description The overall rationale, reason, or intention of the clinical trial. Study Purpose 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 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 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 ICH M11 Section 2 Terminology ICH M11 Section 2 Terminology ICH M11 Protocol Section 2 Data Element Terminology Terminology relevant to the data elements in section 3 of the ICH M11 protocol template. A description of the intercurrent event. Intercurrent Event Description 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 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 A description of the planned strategy to address intercurrent events. Intercurrent Event Strategy 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 for the clinical endpoint of interest, which provides a basis for comparison between treatment conditions. Population-Level Summary 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 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 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 ICH M11 Section 3 Terminology ICH M11 Section 3 Terminology ICH M11 Protocol Section 3 Data Element Terminology Terminology relevant to the data elements in section 4 of the ICH M11 protocol template. 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 An extra or further textual description of the trial design. Additional Description of Trial Design 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 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 A description of the trial duration. Description of Trial Duration 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 A description summarizing the overall trial design and intervention model. Study Design Description An explanation as to the scientific reasons for the choice of the trial design. Study Design Rationale 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 An explanation as to the scientific reasons for the choice of the control types used in the trial. Rationale for Trial Control Type An explanation as to the scientific reasons for the choice of the trial estimand(s). Rationale for Trial Estimand 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 An explanation as to the scientific reasons for why the intervention model was chosen for the trial. Interventional Study Design Rationale 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 An explanation as to the scientific reasons for the trial duration. Rationale for Trial Duration 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 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 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 ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology ICH M11 Protocol Section 4 Data Element Terminology Terminology relevant to the data elements in section 5 of the ICH M11 protocol template. 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 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 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 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 List of characteristics in a protocol, any one of which excludes a potential participant from participation in a study. (CDISC glossary) Exclusion Criteria The criteria in a protocol that prospective participants must meet to be eligible for participation in a study. (CDISC glossary) Inclusion Criteria 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 A description of the restrictions related to participant diet during the trial. Trial Participant Meals and Dietary Restrictions An activity restriction that is different than the one(s) previously specified or mentioned. Other Activity Restrictions A description of the restrictions related to participant physical activity during the trial. Trial Participant Physical Activity Restrictions The process of active consideration of participants for enrollment in a trial, for those potential participants who have failed a prior screening attempt. Rescreening The potential participant who does not meet eligibility (inclusion/exclusion) criteria during the screening period. Trial Screen Failure ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology ICH M11 Protocol Section 5 Data Element Terminology Terminology relevant to the data elements in section 6 of the ICH M11 protocol template. The act or process for documenting the storage, inventory tracking, and disposition of the investigational trial intervention. Study Product Accountability The literal identifier (i.e. distinctive designation) for the arm. Arm Name A characterisation or classification of the study arm. Study Arm Type 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 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 A description of the investigational trial intervention. Description of Investigational Trial Intervention A description of the noninvestigational trial intervention. Description of Noninvestigational Trial Intervention 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 Specified quantity of a medicine, to be taken at one time or at stated intervals. Cumulative Dose 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 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 An indication as to whether the trial intervention is an investigational medicinal product or an auxiliary medicinal product. IMP or NIMP Indicator The literal identifier (i.e. distinctive designation) for the study intervention. Intervention Name The kind of product or procedure studied in a trial. Intervention Type 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 The way in which the investigational trial intervention is dispensed, applied, or tendered to the trial participant. Investigational Trial Intervention Administration A change, alteration, or adjustment to the dose of an investigational trial intervention. Investigational Trial Intervention Dose Modification A description of how a potential investigational trial intervention overdose will be handled. Management of Investigational Trial Intervention Overdose A description of the measures taken to ensure the blinding is maintained. Study Blinding Procedure Description of any noninvestigational intervention that is different than the one(s) previously specified or mentioned. Description of Other Noninvestigational Trial Intervention The technique used to assign trial participants to a trial arm. Participant Assignment to Investigational Intervention Method Concomitant therapy that is approved for use in the trial. Permitted Concomitant Therapy 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 The way in which the investigational trial intervention is prepared for use or administration to the trial participant. Study Product Preparation Concomitant therapy that is banned from use in the trial. Prohibited Concomitant Therapy 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 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 A description of the schedule and periodicity of a treatment or vaccination regimen. Treatment Regimen 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 Path by which the pharmaceutical product is taken into or makes contact with the body. Route of Administration An indication as to whether the investigational intervention is centrally or locally sourced. Investigational Intervention Sourcing Indicator A narrative description containing information about the handling, storage, and distribution of investigational trial intervention. Clinical Trial Investigational Product Handling Instruction Documentation The reason or intention for the use of the trial intervention within the trial arm. Trial Intervention Intent ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology ICH M11 Protocol Section 6 Data Element Terminology Terminology relevant to the data elements in section 7 of the ICH M11 protocol template. 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 The rationale for why the participant either discontinued or withdrew from the trial. Study Subject Discontinuation Rationale The requirements that must be met in order to permanently discontinue the administration of trial intervention. Requirements for Permanent Discontinuation of Trial Intervention The requirements that must be met in order to reintroduce previously withdrawn or temporarily discontinued medical intervention in the same participant. Rechallenge Requirement The requirements that must be met in order to temporarily discontinue the administration of trial intervention. Requirements for Temporary Discontinuation of Trial Intervention ICH M11 Section 7 Terminology ICH M11 Section 7 Terminology ICH M11 Protocol Section 7 Data Element Terminology Terminology relevant to the data elements in section 8 of the ICH M11 protocol template. Trial assessments and procedures related to the baseline epoch of the trial. Baseline Assessments and Procedures Description Trial-related laboratory assessments and procedures. Clinical Laboratory Assessment Trial assessments and procedures related to trial intervention efficacy. Efficacy Assessments and Procedures Description 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 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 A narrative description containing information about the collection, use, and retention of biospecimens, and their use in immunogenicity assessments within the trial. Immunogenicity Assessment A narrative description containing information about medical resource utilisation and the health outcome measures, collection method and participant burden. Healthcare Utilization 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 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 A narrative description containing information about the collection, use, and retention of biospecimens, and their use in pharmacokinetic assessments within the trial. Pharmacokinetic Assessment The procedures for a physical examination of the body and its functions to be conducted for the trial. Physical Examination Any examination performed to assess if a female is gravid. Pregnancy Test A description of the assessments and procedures related to participant safety within the trial. Safety Assessments and Procedures Description Trial assessments and procedures related to the screening epoch of the trial. Screening Assessments and Procedures Description A description of data collection procedures and analysis related to suicidal ideation and behaviour risk monitoring. Suicidal Ideation and Behaviour Risk Monitoring A description of general considerations applicable across trial assessments and procedures. Trial Assessments and Procedures Considerations Description The procedures for measurements of the body's basic functions that provide insight into the health status of the person. Vital Signs ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology ICH M11 Protocol Section 8 Data Element Terminology Terminology relevant to the data elements in section 9 of the ICH M11 protocol template. 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 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 The description of the degree of causality (attributability) between a trial intervention and an event. Causality A concise explanation of the meaning of adverse events within the context of the trial. Definition of Adverse Events A concise explanation of the meaning of medical device product complaints within the context of the trial. Definition of Medical Device Product Complaints A concise explanation of the meaning of product complaints within the context of the trial. Definition of Product Complaints A concise explanation of the meaning of serious adverse events within the context of the trial. Definition of Serious Adverse Events 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 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 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 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 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 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 An event type that is different than the one(s) previously specified or mentioned. Other Trial-Related Safety Event Type 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 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 A description for the procedures used to document an event. Event Recording Procedure Description 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 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 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 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 The description of the intensity (severity) of an event. Severity A description of the specific circumstances and context in which safety events are collected and monitored. Safety Event Situational Scope Description 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 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 ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology ICH M11 Protocol Section 9 Data Element Terminology Terminology relevant to the data elements in the amendment details section of the ICH M11 protocol template. 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 The enrollment description as to whether the amendment scope applies globally, locally, or per cohort across the trial. Amendment Scope Enrollment Description A short description describing the changes introduced in the current version of the protocol. Summary 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 The brief reason for the change introduced in the current or prior version of the protocol. Brief Rationale for Protocol Change 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 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 A description of the change introduced in the current or prior version of the protocol. Description of Protocol Change 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 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 The rationale of greatest importance for the protocol amendment. Primary Reason for Protocol Amendment Additional rationale for the protocol amendment that is not considered the primary rationale. Secondary Reason for Protocol Amendment 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 ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology ICH M11 Protocol Section Amendment Details Data Element Terminology Terminology relevant to the data elements in the title page of the ICH M11 protocol template. A sequence of characters used to uniquely identify a protocol amendment. Amendment Identifier A description as to whether the amendment scope applies globally across the trial. Amendment Scope Global Applicability Indicator The date that the sponsor approved a version of the protocol. Protocol Approval by Sponsor Date The legally registered address of the trial co-sponsor. Co-Sponsor Legal Address The literal identifier (i.e., distinctive designation) of the trial co-sponsor. Co-Sponsor Name A sequence of characters used to identify and/or name the country. Country Code The legally registered address of the device manufacturer. Device Manufacturer Legal Address 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 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 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 The formal descriptive name for the protocol that contains key elements of the study. (CDISC) Official Protocol Title 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 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 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 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 The contact information for the sponsor's representative who can advise on specific trial-related medical questions or problems. Designated Medical Expert Contact Information 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 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 Drug name that is not protected by a trademark, usually descriptive of its chemical structure, and sometimes a public name. Generic Name An indication as to whether the protocol document reflects the original version of the protocol. Original Protocol Indicator 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 A commercial name granted by an authority for use in marketing/registering a product. Proprietary Name A sequence of characters used to identify and/or name the region. Region Identifier A sequence of characters used to identify and/or name the study site. Study Site Identifier 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 The legally registered address of the trial sponsor. Sponsor Legal Address The literal identifier (i.e., distinctive designation) of the trial sponsor. Trial Sponsor Name A sequence of characters assigned by the sponsor that uniquely identifies a specific protocol. Sponsor Protocol Identifier A block of text containing the name and signature of the sponsor's signatory, along with the signature date. Sponsor Signatory A symbol or combination of symbols that are assigned by the sponsor to uniquely identify an experimental intervention. Sponsor's Investigational Product Code The physical or virtual location of the medical expert (as designated by the sponsor) contact information. Location of Medical Expert Contact Information The physical or virtual location of the date on which the sponsor approved the current version of the protocol. Location of Sponsor Approval Date The physical or virtual location of the sponsor signatory information. Location of Sponsor Signatory Information Acronym or abbreviation used publicly to identify the clinical trial. Study Protocol Version Acronym A stage in the clinical research and development of a therapy from first-in-human to post-approval clinical trials. Trial Phase The short descriptive name for the trial. Study Protocol Document Version Public Title The date on which the document is versioned. Document Version Date A string of alphanumeric characters that uniquely identifies a specific version of a study protocol. Study Protocol Version Number 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 ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology ICH M11 Protocol Section Title Page Data Element Terminology A valid value set relevant to the independent committee name responses within the ICH M11 protocol template. A type of safety monitoring committee that monitors dose escalation activities in first-in-human trials. Dose Escalation Committee An external committee whose purpose is to evaluate study data and decide whether a study endpoint or other criterion has been met. Adjudication Committee 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 No person or thing, nobody, not any. None Different than the one(s) previously specified or mentioned. Other Independent Committee Name Response Terminology Independent Committee Name Response Terminology ICH M11 Independent Committee Name Value Set Terminology A valid value set relevant to the intervention model responses within the ICH M11 protocol template. 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 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 Different than the one(s) previously specified or mentioned. Other Participants are assigned to one of two or more treatment groups in parallel for the duration of the study. Parallel Study Groups of participants are assigned to receive interventions based on prior milestones being reached in the study. Group Sequential Design All trial participants are assigned to a single treatment group for the duration of the study. Single Group Study Intervention Model Response Terminology Intervention Model Response Terminology ICH M11 Intervention Model Value Set Terminology A valid value set relevant to the intervention type responses within the ICH M11 protocol template. A technique used to change the behavior of a participant (e.g., psychotherapy, lifestyle counseling, or hypnosis). Behavioral Intervention 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 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 Any procedure or test to diagnose a disease or disorder. Diagnostic Procedure Preparations containing ingredient(s) intended to supplement the diet. Dietary Supplement 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 Introduction of genetic material into cells in order to correct or treat an inherited or acquired disease. Gene Therapy 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 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 Use of targeted or whole body radiation to treat a disease. Radiation Therapy 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 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 Intervention Type Response Terminology Intervention Type Response Terminology ICH M11 Intervention Type Value Set Terminology A valid value set relevant to the intervention use responses within the ICH M11 protocol template. 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 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 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 Any procedure or test to diagnose a disease or disorder. Diagnostic Procedure 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 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 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 Intervention Use Response Terminology Intervention Use Response Terminology ICH M11 Intervention Use Value Set Terminology Terminology associated with the sourcing value set codelist of the ICH M11 protocol template. An indication that the entity is obtained from a central source. Centrally Sourced Indicator An indication that the entity is obtained from a local source. Locally Sourced Indicator Investigational Intervention Sourcing Response Terminology Investigational Intervention Sourcing Response Terminology ICH M11 Sourcing Value Set Terminology A valid value set relevant to the investigational medicinal product indicator responses within the ICH M11 protocol template. A medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial. Investigational Medicinal Product 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 Investigational Medicinal Product Indicator Response Terminology Investigational Medicinal Product Indicator Response Terminology ICH M11 Investigational Medicinal Product Indicator Value Set Terminology Terminology associated with the no yes value set codelist of the ICH M11 protocol template. The non-affirmative response to a question. No The affirmative response to a question. Yes No Yes Response Terminology No Yes Response Terminology ICH M11 No Yes Value Set Terminology A valid value set relevant to the population type responses within the ICH M11 protocol template. An indication that the individual or group of individuals has been diagnosed with the disease of interest or under study. With Disease An indication that the individual or group of individuals has not been diagnosed with the disease of interest or under study. Without Disease Population Type Response Terminology Population Type Response Terminology ICH M11 Population Type Value Set Terminology A valid value set relevant to the protocol section name and number responses within the ICH M11 protocol template. Section 1 of the ICH M11 Protocol standard, PROTOCOL SUMMARY. ICH M11 Protocol Section 1 PROTOCOL SUMMARY Section 1.1 of the ICH M11 Protocol standard, Protocol Synopsis. ICH M11 Protocol Section 1.1 Protocol Synopsis 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 Section 1.1.2 of the ICH M11 Protocol standard, Overall Design. ICH M11 Protocol Section 1.1.2 Overall Design Section 1.2 of the ICH M11 Protocol standard, Trial Schema. ICH M11 Protocol Section 1.2 Trial Schema Section 1.3 of the ICH M11 Protocol standard, Schedule of Activities. ICH M11 Protocol Section 1.3 Schedule of Activities Section 10 of the ICH M11 Protocol standard, STATISTICAL CONSIDERATIONS. ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS Section 10.1 of the ICH M11 Protocol standard, General Considerations. ICH M11 Protocol Section 10.1 General Considerations Section 10.10 of the ICH M11 Protocol standard, Multiplicity Adjustments. ICH M11 Protocol Section 10.10 Multiplicity Adjustments Section 10.11 of the ICH M11 Protocol standard, Sample Size Determination. ICH M11 Protocol Section 10.11 Sample Size Determination Section 10.2 of the ICH M11 Protocol standard, Analysis Sets. ICH M11 Protocol Section 10.2 Analysis Sets 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 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) Section 10.4.1 of the ICH M11 Protocol standard, Primary Objective. ICH M11 Protocol Section 10.4.1 Primary Objective 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 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) 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) Section 10.4.1.4 of the ICH M11 Protocol standard, Sensitivity Analysis. ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis Section 10.4.1.5 of the ICH M11 Protocol standard, Supplementary Analysis. ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis 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) Section 10.5.1 of the ICH M11 Protocol standard, Secondary Objective. ICH M11 Protocol Section 10.5.1 Secondary Objective 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 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) 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) Section 10.5.1.4 of the ICH M11 Protocol standard, Sensitivity Analysis. ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis Section 10.5.1.5 of the ICH M11 Protocol standard, Supplementary Analysis. ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis 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) Section 10.7 of the ICH M11 Protocol standard, Safety Analyses. ICH M11 Protocol Section 10.7 Safety Analyses Section 10.8 of the ICH M11 Protocol standard, Other Analyses. ICH M11 Protocol Section 10.8 Other Analyses Section 10.9 of the ICH M11 Protocol standard, Interim Analyses. ICH M11 Protocol Section 10.9 Interim Analyses 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 Section 11.1 of the ICH M11 Protocol standard, Regulatory and Ethical Considerations. ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations Section 11.10 of the ICH M11 Protocol standard, Protocol Deviations. ICH M11 Protocol Section 11.10 Protocol Deviations Section 11.11 of the ICH M11 Protocol standard, Early Site Closure. ICH M11 Protocol Section 11.11 Early Site Closure Section 11.12 of the ICH M11 Protocol standard, Data Dissemination. ICH M11 Protocol Section 11.12 Data Dissemination Section 11.2 of the ICH M11 Protocol standard, Trial Oversight. ICH M11 Protocol Section 11.2 Trial Oversight Section 11.2.1 of the ICH M11 Protocol standard, Investigator Responsibilities. ICH M11 Protocol Section 11.2.1 Investigator Responsibilities Section 11.2.2 of the ICH M11 Protocol standard, Sponsor Responsibilities. ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities Section 11.3 of the ICH M11 Protocol standard, Informed Consent Process. ICH M11 Protocol Section 11.3 Informed Consent Process 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 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 Section 11.4 of the ICH M11 Protocol standard, Committees. ICH M11 Protocol Section 11.4 Committees Section 11.5 of the ICH M11 Protocol standard, Insurance and Indemnity. ICH M11 Protocol Section 11.5 Insurance and Indemnity Section 11.6 of the ICH M11 Protocol standard, Risk-Based Quality Management. ICH M11 Protocol Section 11.6 Risk-Based Quality Management Section 11.7 of the ICH M11 Protocol standard, Data Governance. ICH M11 Protocol Section 11.7 Data Governance Section 11.8 of the ICH M11 Protocol standard, Data Protection. ICH M11 Protocol Section 11.8 Data Protection Section 11.9 of the ICH M11 Protocol standard, Source Records. ICH M11 Protocol Section 11.9 Source Records Section 12 of the ICH M11 Protocol standard, APPENDIX: SUPPORTING DETAILS. ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS Section 12.1 of the ICH M11 Protocol standard, Clinical Laboratory Tests. ICH M11 Protocol Section 12.1 Clinical Laboratory Tests Section 12.2 of the ICH M11 Protocol standard, Country/Region-Specific Differences. ICH M11 Protocol Section 12.2 Country/Region-Specific Differences Section 12.3 of the ICH M11 Protocol standard, Prior Protocol Amendment(s). ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s) 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 Section 14 of the ICH M11 Protocol standard, APPENDIX: REFERENCES. ICH M11 Protocol Section 14 APPENDIX: REFERENCES Section 2 of the ICH M11 Protocol standard, INTRODUCTION. ICH M11 Protocol Section 2 INTRODUCTION Section 2.1 of the ICH M11 Protocol standard, Purpose of Trial. ICH M11 Protocol Section 2.1 Purpose of Trial 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 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 Section 2.2.1 of the ICH M11 Protocol standard, Benefit Summary. ICH M11 Protocol Section 2.2.2 Benefit Summary 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 Section 3 of the ICH M11 Protocol standard, TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS. ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS 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) Section 3.1.1 of the ICH M11 Protocol standard, Primary Objective. ICH M11 Protocol Section 3.1.1 Primary Objective 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) Section 3.2.1 of the ICH M11 Protocol standard, Secondary Objective. ICH M11 Protocol Section 3.2.1 Secondary Objective Section 3.3 of the ICH M11 Protocol standard, Exploratory Objective(s). ICH M11 Protocol Section 3.3 Exploratory Objective(s) Section 3.3.1 of the ICH M11 Protocol standard, Exploratory Objective. ICH M11 Protocol Section 3.3.1 Exploratory Objective Section 4 of the ICH M11 Protocol standard, TRIAL DESIGN. ICH M11 Protocol Section 4 TRIAL DESIGN Section 4.1 of the ICH M11 Protocol standard, Description of Trial Design. ICH M11 Protocol Section 4.1 Description of Trial Design 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 Section 4.2 of the ICH M11 Protocol standard, Rationale for Trial Design. ICH M11 Protocol Section 4.2 Rationale for Trial Design 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) 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 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 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 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 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 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 Section 4.3 of the ICH M11 Protocol standard, Trial Stopping Rules. ICH M11 Protocol Section 4.3 Trial Stopping Rules 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 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 Section 5 of the ICH M11 Protocol standard, TRIAL POPULATION. ICH M11 Protocol Section 5 TRIAL POPULATION 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 Section 5.2 of the ICH M11 Protocol standard, Inclusion Criteria. ICH M11 Protocol Section 5.2 Inclusion Criteria Section 5.3 of the ICH M11 Protocol standard, Exclusion Criteria. ICH M11 Protocol Section 5.3 Exclusion Criteria Section 5.4 of the ICH M11 Protocol standard, Contraception. ICH M11 Protocol Section 5.4 Contraception 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 Section 5.4.2 of the ICH M11 Protocol standard, Contraception Requirements. ICH M11 Protocol Section 5.4.2 Contraception Requirements Section 5.5 of the ICH M11 Protocol standard, Lifestyle Restrictions. ICH M11 Protocol Section 5.5 Lifestyle Restrictions 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 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 Section 5.5.3 of the ICH M11 Protocol standard, Physical Activity Restrictions. ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions Section 5.5.4 of the ICH M11 Protocol standard, Other Activity Restrictions. ICH M11 Protocol Section 5.5.4 Other Activity Restrictions Section 5.6 of the ICH M11 Protocol standard, Screen Failure and Rescreening. ICH M11 Protocol Section 5.6 Screen Failure and Rescreening Section 6 of the ICH M11 Protocol standard, TRIAL INTERVENTION AND CONCOMITANT THERAPY. ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY 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 Section 6.10 of the ICH M10 Protocol standard, Concomitant Therapy. ICH M11 Protocol Section 6.10 Concomitant Therapy Section 6.10.1 of the ICH M10 Protocol standard, Prohibited Concomitant Therapy. ICH M11 Protocol Section 6.10.1 Prohibited Concomitant Therapy Section 6.10.2 of the ICH M10 Protocol standard, Permitted Concomitant Therapy. ICH M11 Protocol Section 6.10.2 Permitted Concomitant Therapy 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 Section 6.3 of the ICH M11 Protocol standard, Investigational Trial Intervention Administration. ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration 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 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 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 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 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 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 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 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 Section 6.7.2 of the ICH M11 Protocol standard, Randomisation. ICH M11 Protocol Section 6.7.2 Randomisation 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 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 Section 6.8 of the ICH M11 Protocol standard, Investigational Trial Intervention Adherence. ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence 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 Section 6.9.1 of the ICH M11 Protocol standard, Background Trial Intervention. ICH M11 Protocol Section 6.9.1 Background Trial Intervention Section 6.9.2 of the ICH M11 Protocol standard, Rescue Therapy. ICH M11 Protocol Section 6.9.2 Rescue Therapy 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 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 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 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 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 Section 7.1.3 of the ICH M11 Protocol standard, Rechallenge. ICH M11 Protocol Section 7.1.3 Rechallenge 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 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 Section 8 of the ICH M11 Protocol standard, TRIAL ASSESSMENTS AND PROCEDURES. ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES 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 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 Section 8.3 of the ICH M11 Protocol standard, Efficacy Assessments and Procedures. ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures Section 8.4 of the ICH M11 Protocol standard, Safety Assessments and Procedures. ICH M11 Protocol Section 8.4 Safety Assessments and Procedures Section 8.4.1 of the ICH M11 Protocol standard, Physical Examination. ICH M11 Protocol Section 8.4.1 Physical Examination Section 8.4.2 of the ICH M11 Protocol standard, Vital Signs. ICH M11 Protocol Section 8.4.2 Vital Signs Section 8.4.3 of the ICH M11 Protocol standard, Electrocardiograms. ICH M11 Protocol Section 8.4.3 Electrocardiograms Section 8.4.4 of the ICH M11 Protocol standard, Clinical Laboratory Assessments. ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments Section 8.4.5 of the ICH M11 Protocol standard, Pregnancy Testing. ICH M11 Protocol Section 8.4.5 Pregnancy Testing 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 Section 8.5 of the ICH M11 Protocol standard, Pharmacokinetics. ICH M11 Protocol Section 8.5 Pharmacokinetics Section 8.6 of the ICH M11 Protocol standard, Biomarkers. ICH M11 Protocol Section 8.6 Biomarkers 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 Section 8.6.2 of the ICH M11 Protocol standard, Pharmacodynamic Biomarkers. ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers Section 8.6.3 of the ICH M11 Protocol standard, Other Biomarkers. ICH M11 Protocol Section 8.6.3 Other Biomarkers Section 8.7 of the ICH M11 Protocol standard, Immunogenicity Assessments. ICH M11 Protocol Section 8.7 Immunogenicity Assessments 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 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 Section 9.1 of the ICH M11 Protocol standard, Definitions. ICH M11 Protocol Section 9.1 Definitions 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 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 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 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 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 Section 9.2.1 of the ICH M11 Protocol standard, Timing. ICH M11 Protocol Section 9.2.1 Timing Section 9.2.2 of the ICH M11 Protocol standard, Collection Procedures. ICH M11 Protocol Section 9.2.2 Collection Procedures Section 9.2.3 of the ICH M11 Protocol standard, Reporting. ICH M11 Protocol Section 9.2.3 Reporting 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 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 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 Section 9.3 of the ICH M11 Protocol standard, Pregnancy and Postpartum Information. ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information 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 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 Section 9.4 of the ICH M11 Protocol standard, Special Safety Situations. ICH M11 Protocol Section 9.4 Special Safety Situations Amendment Details Section of the ICH M11 Protocol standard, Amendment Details. ICH M11 Protocol Section Amendment Details Title Page Section of the ICH M11 Protocol standard, Title Page. ICH M11 Protocol Section Title Page Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology ICH M11 Protocol Section Name and Number Value Set Terminology A valid value set relevant to the reason for amendment responses within the ICH M11 protocol template. 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 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 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 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 Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol. Investigator/Site Feedback Amendment Reason 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 A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol. Manufacturing Change Amendment Reason 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 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 Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol. New Safety Information Available Amendment Reason Determination of a value is not relevant in the current context. Not Applicable Different than the one(s) previously specified or mentioned. Other A protocol design error necessitates a change(s) to, or formal clarification of, a document. Protocol Design Error Amendment Reason Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol. Recruitment Difficulty Amendment Reason 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 Reason for Amendment Response Terminology Reason for Amendment Response Terminology ICH M11 Reason for Amendment Value Set Terminology A valid value set relevant to the trial arm type responses within the ICH M11 protocol template. An arm describing the active comparator. Active Comparator Arm 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 An arm describing the intervention or treatment plan for a group of participants in the study receiving test product(s). Investigational Arm A study arm without an intervention or treatment. No Intervention Arm An arm describing the placebo comparator. Placebo Control Arm An arm describing the sham comparator. Sham Comparator Arm Trial Arm Type Response Terminology Trial Arm Type Response Terminology ICH M11 Trial Arm Type Value Set Terminology A valid value set relevant to the trial blinding role responses within the ICH M11 protocol template. The primary person in charge of the care of a patient, usually a family member or a designated health care professional. Caregiver 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 Determination of a value is not relevant in the current context. Not Applicable The individual who evaluates the outcome(s) of interest. Outcomes Assessor A member of the clinical study population from whom data are being collected. (CDISC Glossary) Study Participant 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 Trial Blinding Role Response Terminology Trial Blinding Role Response Terminology ICH M11 Trial Blinding Role Value Set Terminology Terminology associated with the trial blind schema value set codelist of the ICH M11 protocol template. 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 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 A study in which participants and study personnel know which intervention each participant is receiving. Open Label Study 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 Trial Blinding Schema Response Terminology Trial Blinding Schema Response Terminology ICH M11 Trial Blind Schema Value Set Terminology A valid value set relevant to the trial intervention assignment method responses within the ICH M11 protocol template. No specific methodology is used to assign trial participants to treatment or control groups. No Intervention Assignment Method Different than the one(s) previously specified or mentioned. Other 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 Trial Intervention Assignment Method Response Terminology Trial Intervention Assignment Method Response Terminology ICH M11 Trial Intervention Assignment Method Value Set Terminology Terminology associated with the trial phase value set codelist of the ICH M11 protocol template. 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 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 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 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 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 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 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 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 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 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 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 Trial Phase Response Terminology Trial Phase Response Terminology ICH M11 Trial Phase Value Set Terminology Terminology associated with the site distribution value set codelist of the ICH M11 protocol template. 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 A clinical trial that is conducted at a single site. Single-Center Study Trial Site Distribution Response Terminology Trial Site Distribution Response Terminology ICH M11 Trial Site Distribution Value Set Terminology Terminology associated with the site geographic scope value set codelist of the ICH M11 protocol template. Of, or pertaining to, an occurrence in more than one country. Multiple Countries Of, or pertaining to, an occurrence in one country. Single Country Trial Site Geographic Scope Response Terminology Trial Site Geographic Scope Response Terminology ICH M11 Trial Site Geographic Scope Value Set Terminology A valid value set relevant to the trial-related safety event type responses within the ICH M11 protocol template. 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 Any concern about the safety, quality, and/or performance of a trial-related drug-device combination. Drug-Device Combination Product Complaint Any event that occurs when the participant is lactating. Lactation Event 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 Different than the one(s) previously specified or mentioned. Other Any event that occurs when the participant is in the stages of recovery post pregnancy and birth event. Post-Partum Event Any event that occurs when the participant or participant's partner becomes pregnant or is pregnant. Pregnancy Event 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 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 Any concern about the safety and/or quality of any trial-related interventions. Trial Intervention Complaint Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology ICH M11 Trial-Related Safety Event Type Value Set Terminology Terminology associated with the units of measure value set codelist of the ICH M11 protocol template. A unit of measurement of time equal to 24 hours. Day A unit of measurement of time equal to 60 minutes. Hour 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 Any period of seven consecutive days. Week 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 Unit of Measure Terminology Unit of Measure Terminology ICH M11 Units of Measure Value Set Terminology