Code Codelist Code Codelist Extensible (Yes/No) Codelist Name ICH Preferred Term ICH Synonym(s) ICH Definition NCI Preferred Term C217274 No Amendment Details Statement Response Terminology Amendment Details Statement Response Terminology Amendment Details Statement Response Terminology A valid value set relevant to the amendment details statement responses within the ICH M11 protocol template. ICH M11 Amendment Details Statement Value Set Terminology C218486 C217274 Amendment Details Statement Response Terminology This is the first protocol amendment. This is the first protocol amendment. First Protocol Amendment C218487 C217274 Amendment Details Statement Response Terminology This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s). 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 C218488 C217274 Amendment Details Statement Response Terminology 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. 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 C218485 C217274 Amendment Details Statement Response Terminology This protocol has not been amended. This protocol has not been amended. Protocol Not Amended C217275 No Amendment Scope Enrollment Description Response Terminology Amendment Scope Enrollment Description Response Terminology Amendment Scope Enrollment Description Response Terminology A valid value set relevant to the amendment scope enrollment description responses within the ICH M11 protocol template. ICH M11 Amendment Scope Enrollment Description Value Set Terminology C218489 C217275 Amendment Scope Enrollment Description Response Terminology By Cohort Covering or affecting a cohort of individuals. By Cohort C68846 C217275 Amendment Scope Enrollment Description Response Terminology Globally Covering or affecting the whole of a system. Global C41065 C217275 Amendment Scope Enrollment Description Response Terminology Locally Covering or affecting a portion of the system. Locally C217047 No Amendment Scope Response Terminology Amendment Scope Response Terminology Amendment Scope Response Terminology Terminology associated with the amendment scope value set codelist of the ICH M11 protocol template. ICH M11 Amendment Scope Value Set Terminology C68846 C217047 Amendment Scope Response Terminology Global Covering or affecting the whole of a system. Global C217026 C217047 Amendment Scope Response Terminology Not Global Covering or affecting a portion of the system. Not Global C217279 No Control Type Response Terminology Control Type Response Terminology Control Type Response Terminology A valid value set relevant to the control type responses within the ICH M11 protocol template. ICH M11 Control Type Value Set Terminology C49649 C217279 Control Type Response Terminology Active Comparator A type of control, which has a demonstrated effect, administered as a comparator to participants in a clinical trial. Active Control C218505 C217279 Control Type Response Terminology Different Dose or Regimen 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 C120841 C217279 Control Type Response Terminology Dose Response A type of control using different doses or regimens of the same treatment across the treatment arms. Dose Response Control C218506 C217279 Control Type Response Terminology External 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 C28280 C217279 Control Type Response Terminology No Control A clinical study that lacks a comparison (i.e., a control) group. Uncontrolled Study C49648 C217279 Control Type Response Terminology Placebo An inactive, identical-appearing drug or treatment that does not contain the test product. Placebo Control C184727 C217279 Control Type Response Terminology Sham Procedure 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 C217342 No ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology ICH M11 Section 1 Terminology Terminology relevant to the data elements in section 1 of the ICH M11 protocol template. ICH M11 Protocol Section 1 Data Element Terminology C218706 C217342 ICH M11 Section 1 Terminology Adaptive Trial Design Indicator An indication as to whether the clinical trial uses an adaptive trial design. Adaptive Trial Design Indicator C218838 C217342 ICH M11 Section 1 Terminology Additional Description of Duration 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 C218714 C217342 ICH M11 Section 1 Terminology Alternate Description of Planned Duration of Trial Intervention An alternative textual narrative for the planned duration of trial intervention. Alternate Description of Planned Duration of Trial Intervention C218717 C217342 ICH M11 Section 1 Terminology Alternate Description of Planned Duration of Trial Participation An alternative narrative for the planned duration of trial participation. Alternate Description of Planned Duration of Trial Participation C218709 C217342 ICH M11 Section 1 Terminology Blinded Roles An identifying designation assigned to a blinded individual within a clinical trial that corresponds with their function. Blinding Role C49647 C217342 ICH M11 Section 1 Terminology Control Type A characterisation or classification of the comparator against which the study intervention is evaluated. Control Type C218708 C217342 ICH M11 Section 1 Terminology Drug/Device Combination Product Indicator An indication as to whether the clinical trial is testing a drug-device combination product. Drug/Device Combination Product Indicator C218718 C217342 ICH M11 Section 1 Terminology Independent Committees An independent group of experts that has oversight over, and conducts periodic review of, specific trial activities. Independent Oversight Committee C142585 C217342 ICH M11 Section 1 Terminology INN A unique name that is globally recognised and public property, which identifies pharmaceutical substances or active pharmaceutical ingredients. International Nonproprietary Name C218475 C217342 ICH M11 Section 1 Terminology Intervention Assignment Method The technique used to assign trial participants to a trial intervention or trial arm. Intervention Assignment Method C98746 C217342 ICH M11 Section 1 Terminology Intervention Model The overall design configuration for assigning intervention to participants. Intervention Model C218707 C217342 ICH M11 Section 1 Terminology Master Protocol Indicator An indication as to whether the protocol is a master protocol. Master Protocol Indicator C49694 C217342 ICH M11 Section 1 Terminology Maximum Age The anticipated maximum age of the participants to be entered in a clinical trial. Planned Maximum Age of Subjects C49693 C217342 ICH M11 Section 1 Terminology Minimum Age The anticipated minimum age of the participants to be entered in a clinical trial. Planned Minimum Age of Subjects C97054 C217342 ICH M11 Section 1 Terminology Nonproprietary Name(s) Drug name that is not protected by a trademark, usually descriptive of its chemical structure, and sometimes a public name. Generic Name C98771 C217342 ICH M11 Section 1 Terminology Number of Arms The planned number of intervention groups. Planned Number of Arms C49692 C217342 ICH M11 Section 1 Terminology Number of Participants The planned number of participants to be entered in a clinical trial. Planned Subject Number C218719 C217342 ICH M11 Section 1 Terminology Other Committees A committee that is different than the one(s) previously specified or mentioned. Other Committee C223138 C217342 ICH M11 Section 1 Terminology Other Intervention Assignment Method Description of any intervention assignment method that is different than the one(s) previously specified or mentioned. Other Intervention Assignment Method C112038 C217342 ICH M11 Section 1 Terminology Population Diagnosis or Condition A description of the condition, disease or disorder that the clinical trial is intended to investigate or address. Trial Indication C218703 C217342 ICH M11 Section 1 Terminology Population Type A characterisation or classification of the trial population. Population Type C218839 C217342 ICH M11 Section 1 Terminology Primary and Secondary Objectives and Estimands A descriptive summary of the primary and secondary objectives and their associated estimands related to the trial. Primary and Secondary Objectives and Estimands Summary C223137 C217342 ICH M11 Section 1 Terminology Randomisation Type A characterisation or classification of the randomisation used to assign trial participants to treatment or control groups. Randomization Type C218711 C217342 ICH M11 Section 1 Terminology randomly assigned to trial intervention/enrolled 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 C132349 C217342 ICH M11 Section 1 Terminology Schedule of Activities 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 C218720 C217342 ICH M11 Section 1 Terminology Schema Notes A brief written record describing the trial schematic. Trial Schematic Note C218704 C217342 ICH M11 Section 1 Terminology Site Distribution An indication as to whether the occurrence applies to a single or multiple trial sites. Site Distribution Indicator C218705 C217342 ICH M11 Section 1 Terminology Site Geographic Scope An indication as to whether the trial is taking place in one or more countries. Site Geographic Scope Indicator C223136 C217342 ICH M11 Section 1 Terminology Stratification Indicator An indication as to whether stratification is used as part of the randomisation process. Stratification Indicator C218710 C217342 ICH M11 Section 1 Terminology Target/Maximum 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 C218713 C217342 ICH M11 Section 1 Terminology total planned duration of trial intervention unit of time The unit of time associated with the numeric value for the planned duration of trial intervention. Planned Duration of Trial Intervention Unit of Time C218712 C217342 ICH M11 Section 1 Terminology total planned duration of trial intervention The numeric value for the planned duration of trial intervention. Planned Duration of Trial Intervention C218716 C217342 ICH M11 Section 1 Terminology total planned duration of trial participation unit of time The unit of time associated with the numeric value for the planned duration of trial participation. Planned Duration of Trial Participation Unit of Time C218715 C217342 ICH M11 Section 1 Terminology total planned duration of trial participation The numeric value for the planned duration of trial participation. Planned Duration of Trial Participation C49658 C217342 ICH M11 Section 1 Terminology Trial Blind Schema 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 C93682 C217342 ICH M11 Section 1 Terminology Trial 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 C50400 C217342 ICH M11 Section 1 Terminology Units of Age Those units of time that are routinely used to express the age of a person. Age Unit C217351 No ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology ICH M11 Section 10 Terminology Terminology relevant to the data elements in section 10 of the ICH M11 protocol template. ICH M11 Protocol Section 10 Data Element Terminology C218807 C217351 ICH M11 Section 10 Terminology Analyses Associated with the Exploratory Objective(s) A description of the statistical model, hypothesis, and methods of analyses for each exploratory objective within the trial. Exploratory Objective Statistical Analysis Method C218802 C217351 ICH M11 Section 10 Terminology Analyses of Demographics and Other Baseline Variables A description of analyses relevant to variables at baseline, for example demographics, related to the trial. Description of Trial Baseline Variable Analysis C218801 C217351 ICH M11 Section 10 Terminology Analysis Sets A description of the set of participants whose data are to be included in the analyses. Description of the Participants Included in Data Analysis C164387 C217351 ICH M11 Section 10 Terminology General Considerations Careful thought or deliberation related to the planned conduct of statistical analyses within the context of the trial. General Statistical Consideration C218803 C217351 ICH M11 Section 10 Terminology 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 primary estimand. Handling of Data in Relation to Primary Estimand(s) C218805 C217351 ICH M11 Section 10 Terminology Handling of Data in Relation to Secondary 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) C218804 C217351 ICH M11 Section 10 Terminology Handling of Missing Data in Relation to Primary 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) C218806 C217351 ICH M11 Section 10 Terminology Handling of Missing Data in Relation to Secondary 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) C142582 C217351 ICH M11 Section 10 Terminology Interim Analyses 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 C218810 C217351 ICH M11 Section 10 Terminology Multiplicity Adjustments 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 C218809 C217351 ICH M11 Section 10 Terminology Other Analyses A description of the analyses that are different than the one(s) previously specified or mentioned. Other Analysis C218808 C217351 ICH M11 Section 10 Terminology Safety Analyses A description of the analyses of relevant safety variables, including adverse events of special interest. Safety Analysis C115467 C217351 ICH M11 Section 10 Terminology Sample Size Determination 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 C218480 C217351 ICH M11 Section 10 Terminology Sensitivity Analysis 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 C218482 C217351 ICH M11 Section 10 Terminology Statistical Analysis Method A description of the statistical model, hypothesis, and methods of analyses for each objective within the trial. Trial-Related Statistical Analysis Method C218481 C217351 ICH M11 Section 10 Terminology Supplementary Analysis 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 C217352 No ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology ICH M11 Section 11 Terminology Terminology relevant to the data elements in section 11 of the ICH M11 protocol template. ICH M11 Protocol Section 11 Data Element Terminology C218819 C217352 ICH M11 Section 11 Terminology Committees A description of the type and administrative structure of any committee associated with the trial. Committee Description C218829 C217352 ICH M11 Section 11 Terminology Criteria for Early Closure The requirements that must be met in order to close a trial site prematurely. Criteria for Early Trial Site Closure C218831 C217352 ICH M11 Section 11 Terminology Data Dissemination A description of whether and which public databases the clinical trial, and results if applicable, will be registered. Study Data Dissemination C218822 C217352 ICH M11 Section 11 Terminology Data Governance 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 C218823 C217352 ICH M11 Section 11 Terminology Data Protection 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 C218828 C217352 ICH M11 Section 11 Terminology Decision Rights for Site Closure 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 C218815 C217352 ICH M11 Section 11 Terminology Description of Assent Process 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 C218816 C217352 ICH M11 Section 11 Terminology Description of Emergency Consent 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 C184390 C217352 ICH M11 Section 11 Terminology Description of Informed 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 C222675 C217352 ICH M11 Section 11 Terminology Identification of Source Records A description of how trial-related source records will be identified. Identification of Source Records Description C218817 C217352 ICH M11 Section 11 Terminology Informed Consent for Rescreening A description of the consent requirements for participants in the event of screen failure and rescreening. Informed Consent Requirements for Rescreening C218818 C217352 ICH M11 Section 11 Terminology Informed Consent for Use of Remaining Samples in Exploratory Research 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 C218820 C217352 ICH M11 Section 11 Terminology Insurance and Indemnity A concise summary of the arrangements for participants insurance and indemnity as required by the applicable regulatory body. Insurance and Indemnity Summary C218825 C217352 ICH M11 Section 11 Terminology Investigator Expectations for Source Records A description of the obligations of the investigator with respect to maintaining and ensuring availability of the source records. Investigator Expectations for Source Records C218813 C217352 ICH M11 Section 11 Terminology Investigator Responsibilities A description of the obligations of the investigator with respect to the trial. Investigator Responsibilities C218827 C217352 ICH M11 Section 11 Terminology Protocol Deviations A description of plans for detecting, reviewing, and reporting any deviations from the protocol. Protocol Deviation Management C218811 C217352 ICH M11 Section 11 Terminology Regulatory and Ethical Considerations Careful thought or deliberation related to the regulatory and ethical aspects of the trial. Trial Regulatory and Ethical Consideration C218830 C217352 ICH M11 Section 11 Terminology Responsibilities Following Early Site Closure 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 C218821 C217352 ICH M11 Section 11 Terminology Risk-Based Quality Management A description of how potential risks and critical to quality factors associated with the trial will be identified and handled. Risk-Based Quality Management C218824 C217352 ICH M11 Section 11 Terminology Source Records Introduction A description of trial-related source records including the importance of source record maintenance and expectations for data traceability. Trial-Related Source Records Description C218814 C217352 ICH M11 Section 11 Terminology Sponsor Responsibilities A description of the obligations of the sponsor with respect to the trial. Sponsor Responsibilities C218826 C217352 ICH M11 Section 11 Terminology Trial Monitor Expectations for Source Records 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 C218812 C217352 ICH M11 Section 11 Terminology Trial Oversight 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 C217353 No ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology ICH M11 Section 12 Terminology Terminology relevant to the data elements in section 12 of the ICH M11 protocol template. ICH M11 Protocol Section 12 Data Element Terminology C220640 C217353 ICH M11 Section 12 Terminology Additional Appendices Extra or supplementary appendices added to the end of a document. Additional Document Appendices C218477 C217353 ICH M11 Section 12 Terminology Amendment Identifier A sequence of characters used to uniquely identify a protocol amendment. Amendment Identifier C218695 C217353 ICH M11 Section 12 Terminology Amendment Scope Enrollment Description The enrollment description as to whether the amendment scope applies globally, locally, or per cohort across the trial. Amendment Scope Enrollment Description C218478 C217353 ICH M11 Section 12 Terminology Approximately <#/%> enrolled 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 C181233 C217353 ICH M11 Section 12 Terminology Brief Rationale for Change The brief reason for the change introduced in the current or prior version of the protocol. Brief Rationale for Protocol Change C25294 C217353 ICH M11 Section 12 Terminology Clinical Laboratory Tests Any procedure that involves testing or manipulating a sample of blood, urine, or other body substance in a laboratory setting. Laboratory Procedure C218832 C217353 ICH M11 Section 12 Terminology Country/Region Identifier A sequence of characters used to identify and/or name a country or region. Country and/or Region Identifier C218834 C217353 ICH M11 Section 12 Terminology Country/Region Specific Protocol Clarifications A description of any country or region-specific clarifications related to a protocol item. Country and/or Region-Specific Protocol Clarifications Description C218833 C217353 ICH M11 Section 12 Terminology Country/Region-Specific Requirements 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 C218483 C217353 ICH M11 Section 12 Terminology Description of Change A description of the change introduced in the current or prior version of the protocol. Description of Protocol Change C218835 C217353 ICH M11 Section 12 Terminology Prior Protocol Amendment(s) 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 C218479 C217353 ICH M11 Section 12 Terminology Section # and Name 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 C218836 C217353 ICH M11 Section 12 Terminology specify alternative location The physical or virtual location of the overview of changes from each prior amendment. Alternative Location of Protocol Changes C132352 C217353 ICH M11 Section 12 Terminology Sponsor Approval Date The date that the sponsor approved a version of the protocol. Protocol Approval by Sponsor Date C217354 No ICH M11 Section 13 Terminology ICH M11 Section 13 Terminology ICH M11 Section 13 Terminology Terminology relevant to the data elements in section 13 of the ICH M11 protocol template. ICH M11 Protocol Section 13 Data Element Terminology C218837 C217354 ICH M11 Section 13 Terminology Glossary of Terms and Abbreviations A list of terms with their abbreviations and/or definitions. Glossary of Terms and Abbreviations C217355 No ICH M11 Section 14 Terminology ICH M11 Section 14 Terminology ICH M11 Section 14 Terminology Terminology relevant to the data elements in section 14 of the ICH M11 protocol template. ICH M11 Protocol Section 14 Data Element Terminology C184397 C217355 ICH M11 Section 14 Terminology References The curated list of sources that are cited within the reference section of the document. Reference List C217343 No ICH M11 Section 2 Terminology ICH M11 Section 2 Terminology ICH M11 Section 2 Terminology Terminology relevant to the data elements in section 2 of the ICH M11 protocol template. ICH M11 Protocol Section 2 Data Element Terminology C218724 C217343 ICH M11 Section 2 Terminology Benefit Summary A short textual description containing the potential physical, psychological, social, legal, and other benefits to the trial participant. Trial Participant Benefit Summary C218725 C217343 ICH M11 Section 2 Terminology Overall Risk-Benefit Assessment A short textual description containing the risks and benefits associated with participation in the trial. Overall Risk-Benefit Assessment Description C146997 C217343 ICH M11 Section 2 Terminology Purpose of Trial The overall rationale, reason, or intention of the clinical trial. Study Purpose C218721 C217343 ICH M11 Section 2 Terminology Trial-specific Intervention Risks and Mitigations 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 C218723 C217343 ICH M11 Section 2 Terminology Trial-specific Other Risks and Mitigations 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 C218722 C217343 ICH M11 Section 2 Terminology Trial-specific Procedure Risks and Mitigations 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 C217344 No ICH M11 Section 3 Terminology ICH M11 Section 3 Terminology ICH M11 Section 3 Terminology Terminology relevant to the data elements in section 3 of the ICH M11 protocol template. ICH M11 Protocol Section 3 Data Element Terminology C188856 C217344 ICH M11 Section 3 Terminology Description of Intercurrent Event A description of the intercurrent event. Intercurrent Event Description C25212 C217344 ICH M11 Section 3 Terminology Endpoint 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 C163559 C217344 ICH M11 Section 3 Terminology Exploratory Objective 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 C188857 C217344 ICH M11 Section 3 Terminology Intercurrent Event Strategy A description of the planned strategy to address intercurrent events. Intercurrent Event Strategy C70833 C217344 ICH M11 Section 3 Terminology Population 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 C188853 C217344 ICH M11 Section 3 Terminology Population-level Summary Population level summary for the clinical endpoint of interest, which provides a basis for comparison between treatment conditions. Population-Level Summary C85826 C217344 ICH M11 Section 3 Terminology Primary Objective 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 C85827 C217344 ICH M11 Section 3 Terminology Secondary 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 C49236 C217344 ICH M11 Section 3 Terminology Treatment 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 C217345 No ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology ICH M11 Section 4 Terminology Terminology relevant to the data elements in section 4 of the ICH M11 protocol template. ICH M11 Protocol Section 4 Data Element Terminology C218738 C217345 ICH M11 Section 4 Terminology Access to Trial Intervention After End of Trial 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 C218728 C217345 ICH M11 Section 4 Terminology Additional Description of Trial Design An extra or further textual description of the trial design. Additional Description of Trial Design C218727 C217345 ICH M11 Section 4 Terminology Description of Level and Method of Blinding 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 C219658 C217345 ICH M11 Section 4 Terminology Description of Method of Assignment to Trial Intervention 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 C218726 C217345 ICH M11 Section 4 Terminology Description of Trial Duration A description of the trial duration. Description of Trial Duration C218737 C217345 ICH M11 Section 4 Terminology End of Trial 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 C147139 C217345 ICH M11 Section 4 Terminology Overall Description of Trial Design and Description of Intervention Model A description summarizing the overall trial design and intervention model. Study Design Description C142705 C217345 ICH M11 Section 4 Terminology Overall Rationale for Trial Design An explanation as to the scientific reasons for the choice of the trial design. Study Design Rationale C218733 C217345 ICH M11 Section 4 Terminology Rationale for Adaptive or Novel Trial Design 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 C218731 C217345 ICH M11 Section 4 Terminology Rationale for Control Type An explanation as to the scientific reasons for the choice of the control types used in the trial. Rationale for Trial Control Type C218730 C217345 ICH M11 Section 4 Terminology Rationale for Estimand(s) An explanation as to the scientific reasons for the choice of the trial estimand(s). Rationale for Trial Estimand C218734 C217345 ICH M11 Section 4 Terminology Rationale for Interim Analysis 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 C215629 C217345 ICH M11 Section 4 Terminology Rationale for Intervention Model An explanation as to the scientific reasons for why the intervention model was chosen for the trial. Interventional Study Design Rationale C218735 C217345 ICH M11 Section 4 Terminology Rationale for Other Trial Design Aspects 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 C218732 C217345 ICH M11 Section 4 Terminology Rationale for Trial Duration An explanation as to the scientific reasons for the trial duration. Rationale for Trial Duration C218729 C217345 ICH M11 Section 4 Terminology Stakeholder Input into Design 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 C218736 C217345 ICH M11 Section 4 Terminology Start of Trial 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 C142698 C217345 ICH M11 Section 4 Terminology Trial Stopping Rules 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 C217346 No ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology ICH M11 Section 5 Terminology Terminology relevant to the data elements in section 5 of the ICH M11 protocol template. ICH M11 Protocol Section 5 Data Element Terminology C218744 C217346 ICH M11 Section 5 Terminology Caffeine, Alcohol, Tobacco, and Other Restrictions 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 C218741 C217346 ICH M11 Section 5 Terminology Contraception Requirements 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 C218740 C217346 ICH M11 Section 5 Terminology Definitions Related to Childbearing Potential 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 C218739 C217346 ICH M11 Section 5 Terminology Description of Trial Population and Rationale 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 C25370 C217346 ICH M11 Section 5 Terminology Exclusion Criterion List of characteristics in a protocol, any one of which excludes a potential participant from participation in a study. (CDISC glossary) Exclusion Criteria C25532 C217346 ICH M11 Section 5 Terminology Inclusion Criterion The criteria in a protocol that prospective participants must meet to be eligible for participation in a study. (CDISC glossary) Inclusion Criteria C218742 C217346 ICH M11 Section 5 Terminology Lifestyle Restrictions 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 C218743 C217346 ICH M11 Section 5 Terminology Meals and Dietary Restrictions A description of the restrictions related to participant diet during the trial. Trial Participant Meals and Dietary Restrictions C218746 C217346 ICH M11 Section 5 Terminology Other Activity Restrictions An activity restriction that is different than the one(s) previously specified or mentioned. Other Activity Restrictions C218745 C217346 ICH M11 Section 5 Terminology Physical Activity Restrictions A description of the restrictions related to participant physical activity during the trial. Trial Participant Physical Activity Restrictions C179373 C217346 ICH M11 Section 5 Terminology Rescreening The process of active consideration of participants for enrollment in a trial, for those potential participants who have failed a prior screening attempt. Rescreening C49628 C217346 ICH M11 Section 5 Terminology Screen Failure The potential participant who does not meet eligibility (inclusion/exclusion) criteria during the screening period. Trial Screen Failure C217347 No ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology ICH M11 Section 6 Terminology Terminology relevant to the data elements in section 6 of the ICH M11 protocol template. ICH M11 Protocol Section 6 Data Element Terminology C176267 C217347 ICH M11 Section 6 Terminology Accountability of Investigational Trial Intervention The act or process for documenting the storage, inventory tracking, and disposition of the investigational trial intervention. Study Product Accountability C93729 C217347 ICH M11 Section 6 Terminology Arm Name The literal identifier (i.e. distinctive designation) for the arm. Arm Name C172457 C217347 ICH M11 Section 6 Terminology Arm Type A characterisation or classification of the study arm. Study Arm Type C222329 C217347 ICH M11 Section 6 Terminology Background Trial Intervention 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 C53630 C217347 ICH M11 Section 6 Terminology Concomitant Therapy 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 C218751 C217347 ICH M11 Section 6 Terminology Description of Investigational Trial Intervention A description of the investigational trial intervention. Description of Investigational Trial Intervention C218759 C217347 ICH M11 Section 6 Terminology Description of Noninvestigational Trial Intervention A description of the noninvestigational trial intervention. Description of Noninvestigational Trial Intervention C218747 C217347 ICH M11 Section 6 Terminology description of the overview of trial interventions or a heading for the optional table 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 C94394 C217347 ICH M11 Section 6 Terminology Dosage Level(s) Specified quantity of a medicine, to be taken at one time or at stated intervals. Cumulative Dose C142517 C217347 ICH M11 Section 6 Terminology Dosage Strength(s) 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 C218757 C217347 ICH M11 Section 6 Terminology Emergency Unblinding at the Site 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 C218749 C217347 ICH M11 Section 6 Terminology IMP or NIMP An indication as to whether the trial intervention is an investigational medicinal product or an auxiliary medicinal product. IMP or NIMP Indicator C177930 C217347 ICH M11 Section 6 Terminology Intervention Name The literal identifier (i.e. distinctive designation) for the study intervention. Intervention Name C98747 C217347 ICH M11 Section 6 Terminology Intervention Type The kind of product or procedure studied in a trial. Intervention Type C218758 C217347 ICH M11 Section 6 Terminology Investigational Trial Intervention Adherence 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 C218753 C217347 ICH M11 Section 6 Terminology Investigational Trial Intervention Administration The way in which the investigational trial intervention is dispensed, applied, or tendered to the trial participant. Investigational Trial Intervention Administration C218754 C217347 ICH M11 Section 6 Terminology Investigational Trial Intervention Dose Modification A change, alteration, or adjustment to the dose of an investigational trial intervention. Investigational Trial Intervention Dose Modification C218755 C217347 ICH M11 Section 6 Terminology Management of Investigational Trial Intervention Overdose A description of how a potential investigational trial intervention overdose will be handled. Management of Investigational Trial Intervention Overdose C189349 C217347 ICH M11 Section 6 Terminology Measures to Maintain Blinding A description of the measures taken to ensure the blinding is maintained. Study Blinding Procedure C218761 C217347 ICH M11 Section 6 Terminology Other Noninvestigational Trial Intervention Description of any noninvestigational intervention that is different than the one(s) previously specified or mentioned. Description of Other Noninvestigational Trial Intervention C218756 C217347 ICH M11 Section 6 Terminology Participant Assignment to Investigational Trial Intervention The technique used to assign trial participants to a trial arm. Participant Assignment to Investigational Intervention Method C218763 C217347 ICH M11 Section 6 Terminology Permitted Concomitant Therapy Concomitant therapy that is approved for use in the trial. Permitted Concomitant Therapy C42636 C217347 ICH M11 Section 6 Terminology Pharmaceutical Dose Form 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 C176274 C217347 ICH M11 Section 6 Terminology Preparation of Investigational Trial Intervention The way in which the investigational trial intervention is prepared for use or administration to the trial participant. Study Product Preparation C218762 C217347 ICH M11 Section 6 Terminology Prohibited Concomitant Therapy Concomitant therapy that is banned from use in the trial. Prohibited Concomitant Therapy C25196 C217347 ICH M11 Section 6 Terminology Randomisation 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 C218752 C217347 ICH M11 Section 6 Terminology Rationale for Investigational Trial Intervention Dose and Regimen 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 C15697 C217347 ICH M11 Section 6 Terminology Regimen/Treatment Period/Vaccination Regimen A description of the schedule and periodicity of a treatment or vaccination regimen. Treatment Regimen C222330 C217347 ICH M11 Section 6 Terminology Rescue Therapy 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 C38114 C217347 ICH M11 Section 6 Terminology Route of Administration Path by which the pharmaceutical product is taken into or makes contact with the body. Route of Administration C218750 C217347 ICH M11 Section 6 Terminology Sourcing An indication as to whether the investigational intervention is centrally or locally sourced. Investigational Intervention Sourcing Indicator C115525 C217347 ICH M11 Section 6 Terminology Storage and Handling of Investigational Trial Intervention A narrative description containing information about the handling, storage, and distribution of investigational trial intervention. Clinical Trial Investigational Product Handling Instruction Documentation C218748 C217347 ICH M11 Section 6 Terminology Use The reason or intention for the use of the trial intervention within the trial arm. Trial Intervention Intent C217348 No ICH M11 Section 7 Terminology ICH M11 Section 7 Terminology ICH M11 Section 7 Terminology Terminology relevant to the data elements in section 7 of the ICH M11 protocol template. ICH M11 Protocol Section 7 Data Element Terminology C218768 C217348 ICH M11 Section 7 Terminology Management of Loss to Follow-Up 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 C218767 C217348 ICH M11 Section 7 Terminology Participant Discontinuation or Withdrawal from Trial The rationale for why the participant either discontinued or withdrew from the trial. Study Subject Discontinuation Rationale C218764 C217348 ICH M11 Section 7 Terminology Permanent Discontinuation of Trial Intervention The requirements that must be met in order to permanently discontinue the administration of trial intervention. Requirements for Permanent Discontinuation of Trial Intervention C218766 C217348 ICH M11 Section 7 Terminology Rechallenge The requirements that must be met in order to reintroduce previously withdrawn or temporarily discontinued medical intervention in the same participant. Rechallenge Requirement C218765 C217348 ICH M11 Section 7 Terminology Temporary Discontinuation of Trial Intervention The requirements that must be met in order to temporarily discontinue the administration of trial intervention. Requirements for Temporary Discontinuation of Trial Intervention C217349 No ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology ICH M11 Section 8 Terminology Terminology relevant to the data elements in section 8 of the ICH M11 protocol template. ICH M11 Protocol Section 8 Data Element Terminology C218771 C217349 ICH M11 Section 8 Terminology Baseline Assessments and Procedures Trial assessments and procedures related to the baseline epoch of the trial. Baseline Assessments and Procedures Description C218774 C217349 ICH M11 Section 8 Terminology Clinical Laboratory Assessments Trial-related laboratory assessments and procedures. Clinical Laboratory Assessment C218772 C217349 ICH M11 Section 8 Terminology Efficacy Assessments and Procedures Trial assessments and procedures related to trial intervention efficacy. Efficacy Assessments and Procedures Description C168186 C217349 ICH M11 Section 8 Terminology Electrocardiograms 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 C218777 C217349 ICH M11 Section 8 Terminology Genetics, Genomics, Pharmacogenetics and Pharmacogenomics 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 C218780 C217349 ICH M11 Section 8 Terminology Immunogenicity Assessments A narrative description containing information about the collection, use, and retention of biospecimens, and their use in immunogenicity assessments within the trial. Immunogenicity Assessment C176849 C217349 ICH M11 Section 8 Terminology Medical Resource Utilisation and Health Economics A narrative description containing information about medical resource utilisation and the health outcome measures, collection method and participant burden. Healthcare Utilization C218779 C217349 ICH M11 Section 8 Terminology Other Biomarkers 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 C218778 C217349 ICH M11 Section 8 Terminology Pharmacodynamic Biomarkers 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 C218776 C217349 ICH M11 Section 8 Terminology Pharmacokinetics A narrative description containing information about the collection, use, and retention of biospecimens, and their use in pharmacokinetic assessments within the trial. Pharmacokinetic Assessment C20989 C217349 ICH M11 Section 8 Terminology Physical Examination The procedures for a physical examination of the body and its functions to be conducted for the trial. Physical Examination C92949 C217349 ICH M11 Section 8 Terminology Pregnancy Testing Any examination performed to assess if a female is gravid. Pregnancy Test C218773 C217349 ICH M11 Section 8 Terminology Safety Assessments and Procedures A description of the assessments and procedures related to participant safety within the trial. Safety Assessments and Procedures Description C218770 C217349 ICH M11 Section 8 Terminology Screening Assessments and Procedures Trial assessments and procedures related to the screening epoch of the trial. Screening Assessments and Procedures Description C218775 C217349 ICH M11 Section 8 Terminology Suicidal Ideation and Behaviour Risk Monitoring A description of data collection procedures and analysis related to suicidal ideation and behaviour risk monitoring. Suicidal Ideation and Behaviour Risk Monitoring C218769 C217349 ICH M11 Section 8 Terminology Trial Assessments and Procedures Considerations A description of general considerations applicable across trial assessments and procedures. Trial Assessments and Procedures Considerations Description C154628 C217349 ICH M11 Section 8 Terminology Vital Signs The procedures for measurements of the body's basic functions that provide insight into the health status of the person. Vital Signs C217350 No ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology ICH M11 Section 9 Terminology Terminology relevant to the data elements in section 9 of the ICH M11 protocol template. ICH M11 Protocol Section 9 Data Element Terminology C217358 C217350 ICH M11 Section 9 Terminology Adverse Events of Special Interest 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 C218790 C217350 ICH M11 Section 9 Terminology Back-up Method for Reporting 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 C82552 C217350 ICH M11 Section 9 Terminology Causality The description of the degree of causality (attributability) between a trial intervention and an event. Causality C218476 C217350 ICH M11 Section 9 Terminology Definitions of Adverse Events A concise explanation of the meaning of adverse events within the context of the trial. Definition of Adverse Events C218783 C217350 ICH M11 Section 9 Terminology Definitions of Medical Device Product Complaints A concise explanation of the meaning of medical device product complaints within the context of the trial. Definition of Medical Device Product Complaints C218782 C217350 ICH M11 Section 9 Terminology Definitions of Product Complaints A concise explanation of the meaning of product complaints within the context of the trial. Definition of Product Complaints C218781 C217350 ICH M11 Section 9 Terminology Definitions of Serious Adverse Events A concise explanation of the meaning of serious adverse events within the context of the trial. Definition of Serious Adverse Events C218797 C217350 ICH M11 Section 9 Terminology Disease-related Events or Outcomes Not Qualifying as AEs or SAEs 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 C218791 C217350 ICH M11 Section 9 Terminology Event Collection and Reporting Timing 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 C218784 C217350 ICH M11 Section 9 Terminology Event Type 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 C218794 C217350 ICH M11 Section 9 Terminology Follow-up 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 C218792 C217350 ICH M11 Section 9 Terminology Identification 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 C218789 C217350 ICH M11 Section 9 Terminology Method for Reporting 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 C222263 C217350 ICH M11 Section 9 Terminology Other Event Type An event type that is different than the one(s) previously specified or mentioned. Other Trial-Related Safety Event Type C218798 C217350 ICH M11 Section 9 Terminology Participants Who Become Pregnant During the Trial 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 C218799 C217350 ICH M11 Section 9 Terminology Participants Whose Partners Become Pregnant During the Trial 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 C218793 C217350 ICH M11 Section 9 Terminology Recording A description for the procedures used to document an event. Event Recording Procedure Description C218796 C217350 ICH M11 Section 9 Terminology Regulatory Reporting Requirements 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 C218787 C217350 ICH M11 Section 9 Terminology Reportable Period End 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 C218786 C217350 ICH M11 Section 9 Terminology Reportable Period Start 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 C218795 C217350 ICH M11 Section 9 Terminology Reporting 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 C25676 C217350 ICH M11 Section 9 Terminology Severity The description of the intensity (severity) of an event. Severity C218785 C217350 ICH M11 Section 9 Terminology Situational Scope A description of the specific circumstances and context in which safety events are collected and monitored. Safety Event Situational Scope Description C218800 C217350 ICH M11 Section 9 Terminology Special Safety Situations 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 C218788 C217350 ICH M11 Section 9 Terminology Timing for Reporting to Sponsor or Designee 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 C217357 No ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology ICH M11 Section Amendment Details Terminology Terminology relevant to the data elements in the amendment details section of the ICH M11 protocol template. ICH M11 Protocol Section Amendment Details Data Element Terminology C218694 C217357 ICH M11 Section Amendment Details Terminology Amendment Details 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 C218695 C217357 ICH M11 Section Amendment Details Terminology Amendment Scope Enrollment Definition The enrollment description as to whether the amendment scope applies globally, locally, or per cohort across the trial. Amendment Scope Enrollment Description C42581 C217357 ICH M11 Section Amendment Details Terminology Amendment Summary A short description describing the changes introduced in the current version of the protocol. Summary C218478 C217357 ICH M11 Section Amendment Details Terminology Approximately <#/%> enrolled 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 C181233 C217357 ICH M11 Section Amendment Details Terminology Brief Rationale for Change The brief reason for the change introduced in the current or prior version of the protocol. Brief Rationale for Protocol Change C218701 C217357 ICH M11 Section Amendment Details Terminology Briefly Explain Substantial Impact on Data 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 C218699 C217357 ICH M11 Section Amendment Details Terminology Briefly Explain Substantial Impact On Safety 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 C218483 C217357 ICH M11 Section Amendment Details Terminology Description of Change A description of the change introduced in the current or prior version of the protocol. Description of Protocol Change C218700 C217357 ICH M11 Section Amendment Details Terminology Is this amendment likely to have a substantial impact on the reliability and robustness of the data generated in the clinical trial? 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 C218698 C217357 ICH M11 Section Amendment Details Terminology Is this amendment likely to have a substantial impact on the safety or rights of the participants? 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 C218696 C217357 ICH M11 Section Amendment Details Terminology Primary Reason for Amendment The rationale of greatest importance for the protocol amendment. Primary Reason for Protocol Amendment C218697 C217357 ICH M11 Section Amendment Details Terminology Secondary Reason for Amendment Additional rationale for the protocol amendment that is not considered the primary rationale. Secondary Reason for Protocol Amendment C218479 C217357 ICH M11 Section Amendment Details Terminology Section # and Name 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 C217356 No ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology ICH M11 Section Title Page Terminology Terminology relevant to the data elements in the title page of the ICH M11 protocol template. ICH M11 Protocol Section Title Page Data Element Terminology C218477 C217356 ICH M11 Section Title Page Terminology Amendment Identifier A sequence of characters used to uniquely identify a protocol amendment. Amendment Identifier C218673 C217356 ICH M11 Section Title Page Terminology Amendment Scope A description as to whether the amendment scope applies globally across the trial. Amendment Scope Global Applicability Indicator C132352 C217356 ICH M11 Section Title Page Terminology Approval Date The date that the sponsor approved a version of the protocol. Protocol Approval by Sponsor Date C218679 C217356 ICH M11 Section Title Page Terminology Co-Sponsor Legal Address The legally registered address of the trial co-sponsor. Co-Sponsor Legal Address C218678 C217356 ICH M11 Section Title Page Terminology Co-Sponsor Name The literal identifier (i.e., distinctive designation) of the trial co-sponsor. Co-Sponsor Name C20108 C217356 ICH M11 Section Title Page Terminology Country Identifier A sequence of characters used to identify and/or name the country. Country Code C218683 C217356 ICH M11 Section Title Page Terminology Device Manufacturer Legal Address The legally registered address of the device manufacturer. Device Manufacturer Legal Address C218682 C217356 ICH M11 Section Title Page Terminology Device Manufacturer Name 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 C218684 C217356 ICH M11 Section Title Page Terminology EU CT Number 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 C218685 C217356 ICH M11 Section Title Page Terminology FDA IND 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 C132346 C217356 ICH M11 Section Title Page Terminology Full Title The formal descriptive name for the protocol that contains key elements of the study. (CDISC) Official Protocol Title C218686 C217356 ICH M11 Section Title Page Terminology IDE Number 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 C218687 C217356 ICH M11 Section Title Page Terminology jRCT 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 C218681 C217356 ICH M11 Section Title Page Terminology Local Sponsor Legal Address 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 C218680 C217356 ICH M11 Section Title Page Terminology Local Sponsor Name 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 C218693 C217356 ICH M11 Section Title Page Terminology Medical Expert contact information (as designated by sponsor) The contact information for the sponsor's representative who can advise on specific trial-related medical questions or problems. Designated Medical Expert Contact Information C172240 C217356 ICH M11 Section Title Page Terminology NCT Number 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 C218688 C217356 ICH M11 Section Title Page Terminology NMPA IND Number 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 C97054 C217356 ICH M11 Section Title Page Terminology Nonproprietary Name(s) Drug name that is not protected by a trademark, usually descriptive of its chemical structure, and sometimes a public name. Generic Name C218672 C217356 ICH M11 Section Title Page Terminology Original Protocol Indicator An indication as to whether the protocol document reflects the original version of the protocol. Original Protocol Indicator C218690 C217356 ICH M11 Section Title Page Terminology Other Regulatory or Clinical Trial Identifier 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 C71898 C217356 ICH M11 Section Title Page Terminology Proprietary Name(s) A commercial name granted by an authority for use in marketing/registering a product. Proprietary Name C218674 C217356 ICH M11 Section Title Page Terminology Region Identifier A sequence of characters used to identify and/or name the region. Region Identifier C83081 C217356 ICH M11 Section Title Page Terminology Site Identifier A sequence of characters used to identify and/or name the study site. Study Site Identifier C181236 C217356 ICH M11 Section Title Page Terminology Sponsor Confidentiality Statement 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 C218677 C217356 ICH M11 Section Title Page Terminology Sponsor Legal Address The legally registered address of the trial sponsor. Sponsor Legal Address C222495 C217356 ICH M11 Section Title Page Terminology Sponsor Name The literal identifier (i.e., distinctive designation) of the trial sponsor. Trial Sponsor Name C132351 C217356 ICH M11 Section Title Page Terminology Sponsor Protocol Identifier A sequence of characters assigned by the sponsor that uniquely identifies a specific protocol. Sponsor Protocol Identifier C222014 C217356 ICH M11 Section Title Page Terminology sponsor signatory (e.g., name, title, signature and date) A block of text containing the name and signature of the sponsor's signatory, along with the signature date. Sponsor Signatory C218675 C217356 ICH M11 Section Title Page Terminology Sponsor's Investigational Product Code(s) A symbol or combination of symbols that are assigned by the sponsor to uniquely identify an experimental intervention. Sponsor's Investigational Product Code C222063 C217356 ICH M11 Section Title Page Terminology state location where Medical Expert contact information can be found The physical or virtual location of the medical expert (as designated by the sponsor) contact information. Location of Medical Expert Contact Information C218484 C217356 ICH M11 Section Title Page Terminology State location where sponsor approval information can be found The physical or virtual location of the date on which the sponsor approved the current version of the protocol. Location of Sponsor Approval Date C222064 C217356 ICH M11 Section Title Page Terminology state location where sponsor signatory information can be found (e.g., electronic signature) The physical or virtual location of the sponsor signatory information. Location of Sponsor Signatory Information C94108 C217356 ICH M11 Section Title Page Terminology Trial Acronym Acronym or abbreviation used publicly to identify the clinical trial. Study Protocol Version Acronym C48281 C217356 ICH M11 Section Title Page Terminology Trial Phase A stage in the clinical research and development of a therapy from first-in-human to post-approval clinical trials. Trial Phase C94105 C217356 ICH M11 Section Title Page Terminology Trial Short Title The short descriptive name for the trial. Study Protocol Document Version Public Title C93813 C217356 ICH M11 Section Title Page Terminology Version Date The date on which the document is versioned. Document Version Date C181232 C217356 ICH M11 Section Title Page Terminology Version Number A string of alphanumeric characters that uniquely identifies a specific version of a study protocol. Study Protocol Version Number C218689 C217356 ICH M11 Section Title Page Terminology WHO/UTN 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 C217282 No Independent Committee Name Response Terminology Independent Committee Name Response Terminology Independent Committee Name Response Terminology A valid value set relevant to the independent committee name responses within the ICH M11 protocol template. ICH M11 Independent Committee Name Value Set Terminology C215671 C217282 Independent Committee Name Response Terminology Dose Escalation Committee A type of safety monitoring committee that monitors dose escalation activities in first-in-human trials. Dose Escalation Committee C78726 C217282 Independent Committee Name Response Terminology Endpoint Adjudication 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 C142578 C217282 Independent Committee Name Response Terminology Independent Data Monitoring 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 C41132 C217282 Independent Committee Name Response Terminology None No person or thing, nobody, not any. None C17649 C217282 Independent Committee Name Response Terminology Other Different than the one(s) previously specified or mentioned. Other C217277 No Intervention Model Response Terminology Intervention Model Response Terminology Intervention Model Response Terminology A valid value set relevant to the intervention model responses within the ICH M11 protocol template. ICH M11 Intervention Model Value Set Terminology C82637 C217277 Intervention Model Response Terminology Cross-over 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 C82638 C217277 Intervention Model Response Terminology Factorial 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 C17649 C217277 Intervention Model Response Terminology Other Different than the one(s) previously specified or mentioned. Other C82639 C217277 Intervention Model Response Terminology Parallel Group Participants are assigned to one of two or more treatment groups in parallel for the duration of the study. Parallel Study C142568 C217277 Intervention Model Response Terminology Sequential Groups of participants are assigned to receive interventions based on prior milestones being reached in the study. Group Sequential Design C82640 C217277 Intervention Model Response Terminology Single Group All trial participants are assigned to a single treatment group for the duration of the study. Single Group Study C217284 No Intervention Type Response Terminology Intervention Type Response Terminology Intervention Type Response Terminology A valid value set relevant to the intervention type responses within the ICH M11 protocol template. ICH M11 Intervention Type Value Set Terminology C15184 C217284 Intervention Type Response Terminology Behavioural A technique used to change the behavior of a participant (e.g., psychotherapy, lifestyle counseling, or hypnosis). Behavioral Intervention C307 C217284 Intervention Type Response Terminology Biologic 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 C54696 C217284 Intervention Type Response Terminology Combination Product 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 C18020 C217284 Intervention Type Response Terminology Diagnostic Any procedure or test to diagnose a disease or disorder. Diagnostic Procedure C1505 C217284 Intervention Type Response Terminology Dietary Supplement Preparations containing ingredient(s) intended to supplement the diet. Dietary Supplement C1909 C217284 Intervention Type Response Terminology Drug 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 C15238 C217284 Intervention Type Response Terminology Genetic Introduction of genetic material into cells in order to correct or treat an inherited or acquired disease. Gene Therapy C16830 C217284 Intervention Type Response Terminology Medical Device 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 C218507 C217284 Intervention Type Response Terminology Non-Surgical Procedure 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 C15313 C217284 Intervention Type Response Terminology Radiation Use of targeted or whole body radiation to treat a disease. Radiation Therapy C15329 C217284 Intervention Type Response Terminology Surgery 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 C923 C217284 Intervention Type Response Terminology Vaccine 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 C217285 No Intervention Use Response Terminology Intervention Use Response Terminology Intervention Use Response Terminology A valid value set relevant to the intervention use responses within the ICH M11 protocol template. ICH M11 Intervention Use Value Set Terminology C207614 C217285 Intervention Use Response Terminology Additional Required Treatment 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 C165822 C217285 Intervention Use Response Terminology Background Treatment 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 C158128 C217285 Intervention Use Response Terminology Challenge Agent 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 C18020 C217285 Intervention Use Response Terminology Diagnostic Any procedure or test to diagnose a disease or disorder. Diagnostic Procedure C41161 C217285 Intervention Use Response Terminology Experimental Intervention 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 C753 C217285 Intervention Use Response Terminology Placebo 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 C165835 C217285 Intervention Use Response Terminology Rescue Medicine 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 C217052 No Investigational Intervention Sourcing Response Terminology Investigational Intervention Sourcing Response Terminology Investigational Intervention Sourcing Response Terminology Terminology associated with the sourcing value set codelist of the ICH M11 protocol template. ICH M11 Sourcing Value Set Terminology C215659 C217052 Investigational Intervention Sourcing Response Terminology Centrally Sourced An indication that the entity is obtained from a central source. Centrally Sourced Indicator C215660 C217052 Investigational Intervention Sourcing Response Terminology Locally Sourced An indication that the entity is obtained from a local source. Locally Sourced Indicator C217286 No Investigational Medicinal Product Indicator Response Terminology Investigational Medicinal Product Indicator Response Terminology Investigational Medicinal Product Indicator Response Terminology A valid value set relevant to the investigational medicinal product indicator responses within the ICH M11 protocol template. ICH M11 Investigational Medicinal Product Indicator Value Set Terminology C202579 C217286 Investigational Medicinal Product Indicator Response Terminology IMP A medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial. Investigational Medicinal Product C156473 C217286 Investigational Medicinal Product Indicator Response Terminology NIMP 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 C217046 No No Yes Response Terminology No Yes Response Terminology No Yes Response Terminology Terminology associated with the no yes value set codelist of the ICH M11 protocol template. ICH M11 No Yes Value Set Terminology C49487 C217046 No Yes Response Terminology No The non-affirmative response to a question. No C49488 C217046 No Yes Response Terminology Yes The affirmative response to a question. Yes C217278 No Population Type Response Terminology Population Type Response Terminology Population Type Response Terminology A valid value set relevant to the population type responses within the ICH M11 protocol template. ICH M11 Population Type Value Set Terminology C218503 C217278 Population Type Response Terminology With Disease An indication that the individual or group of individuals has been diagnosed with the disease of interest or under study. With Disease C218504 C217278 Population Type Response Terminology Without Disease An indication that the individual or group of individuals has not been diagnosed with the disease of interest or under study. Without Disease C217272 No Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology Protocol Section Name and Number Response Terminology A valid value set relevant to the protocol section name and number responses within the ICH M11 protocol template. ICH M11 Protocol Section Name and Number Value Set Terminology C218514 C217272 Protocol Section Name and Number Response Terminology 1 PROTOCOL SUMMARY Section 1 of the ICH M11 Protocol standard, PROTOCOL SUMMARY. ICH M11 Protocol Section 1 PROTOCOL SUMMARY C218515 C217272 Protocol Section Name and Number Response Terminology 1.1 Protocol Synopsis Section 1.1 of the ICH M11 Protocol standard, Protocol Synopsis. ICH M11 Protocol Section 1.1 Protocol Synopsis C218516 C217272 Protocol Section Name and Number Response Terminology 1.1.1 Primary and Secondary Objectives and Estimands 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 C218517 C217272 Protocol Section Name and Number Response Terminology 1.1.2 Overall Design Section 1.1.2 of the ICH M11 Protocol standard, Overall Design. ICH M11 Protocol Section 1.1.2 Overall Design C218518 C217272 Protocol Section Name and Number Response Terminology 1.2 Trial Schema Section 1.2 of the ICH M11 Protocol standard, Trial Schema. ICH M11 Protocol Section 1.2 Trial Schema C218519 C217272 Protocol Section Name and Number Response Terminology 1.3 Schedule of Activities Section 1.3 of the ICH M11 Protocol standard, Schedule of Activities. ICH M11 Protocol Section 1.3 Schedule of Activities C218625 C217272 Protocol Section Name and Number Response Terminology 10 STATISTICAL CONSIDERATIONS Section 10 of the ICH M11 Protocol standard, STATISTICAL CONSIDERATIONS. ICH M11 Protocol Section 10 STATISTICAL CONSIDERATIONS C218626 C217272 Protocol Section Name and Number Response Terminology 10.1 General Considerations Section 10.1 of the ICH M11 Protocol standard, General Considerations. ICH M11 Protocol Section 10.1 General Considerations C218647 C217272 Protocol Section Name and Number Response Terminology 10.10 Multiplicity Adjustments Section 10.10 of the ICH M11 Protocol standard, Multiplicity Adjustments. ICH M11 Protocol Section 10.10 Multiplicity Adjustments C218648 C217272 Protocol Section Name and Number Response Terminology 10.11 Sample Size Determination Section 10.11 of the ICH M11 Protocol standard, Sample Size Determination. ICH M11 Protocol Section 10.11 Sample Size Determination C218627 C217272 Protocol Section Name and Number Response Terminology 10.2 Analysis Sets Section 10.2 of the ICH M11 Protocol standard, Analysis Sets. ICH M11 Protocol Section 10.2 Analysis Sets C218628 C217272 Protocol Section Name and Number Response Terminology 10.3 Analyses of Demographics and Other Baseline Variables 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 C218629 C217272 Protocol Section Name and Number Response Terminology 10.4 Analyses Associated with the Primary Objective(s) 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) C218630 C217272 Protocol Section Name and Number Response Terminology 10.4.1 Primary Objective Section 10.4.1 of the ICH M11 Protocol standard, Primary Objective. ICH M11 Protocol Section 10.4.1 Primary Objective C218631 C217272 Protocol Section Name and Number Response Terminology 10.4.1.1 Statistical Analysis Method 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 C218632 C217272 Protocol Section Name and Number Response Terminology 10.4.1.2 Handling of Data in Relation to Primary Estimand(s) 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) C218633 C217272 Protocol Section Name and Number Response Terminology 10.4.1.3 Handling of Missing 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) C218634 C217272 Protocol Section Name and Number Response Terminology 10.4.1.4 Sensitivity Analysis Section 10.4.1.4 of the ICH M11 Protocol standard, Sensitivity Analysis. ICH M11 Protocol Section 10.4.1.4 Sensitivity Analysis C218635 C217272 Protocol Section Name and Number Response Terminology 10.4.1.5 Supplementary Analysis Section 10.4.1.5 of the ICH M11 Protocol standard, Supplementary Analysis. ICH M11 Protocol Section 10.4.1.5 Supplementary Analysis C218636 C217272 Protocol Section Name and Number Response Terminology 10.5 Analyses Associated with the Secondary Objective(s) 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) C218637 C217272 Protocol Section Name and Number Response Terminology 10.5.1 Secondary Objective Section 10.5.1 of the ICH M11 Protocol standard, Secondary Objective. ICH M11 Protocol Section 10.5.1 Secondary Objective C218638 C217272 Protocol Section Name and Number Response Terminology 10.5.1.1 Statistical Analysis Method 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 C218639 C217272 Protocol Section Name and Number Response Terminology 10.5.1.2 Handling of Data in Relation to Secondary Estimand(s) 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) C218640 C217272 Protocol Section Name and Number Response Terminology 10.5.1.3 Handling of Missing 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) C218641 C217272 Protocol Section Name and Number Response Terminology 10.5.1.4 Sensitivity Analysis Section 10.5.1.4 of the ICH M11 Protocol standard, Sensitivity Analysis. ICH M11 Protocol Section 10.5.1.4 Sensitivity Analysis C218642 C217272 Protocol Section Name and Number Response Terminology 10.5.1.5 Supplementary Analysis Section 10.5.1.5 of the ICH M11 Protocol standard, Supplementary Analysis. ICH M11 Protocol Section 10.5.1.5 Supplementary Analysis C218643 C217272 Protocol Section Name and Number Response Terminology 10.6 Analyses Associated with the Exploratory Objective(s) 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) C218644 C217272 Protocol Section Name and Number Response Terminology 10.7 Safety Analyses Section 10.7 of the ICH M11 Protocol standard, Safety Analyses. ICH M11 Protocol Section 10.7 Safety Analyses C218645 C217272 Protocol Section Name and Number Response Terminology 10.8 Other Analyses Section 10.8 of the ICH M11 Protocol standard, Other Analyses. ICH M11 Protocol Section 10.8 Other Analyses C218646 C217272 Protocol Section Name and Number Response Terminology 10.9 Interim Analyses Section 10.9 of the ICH M11 Protocol standard, Interim Analyses. ICH M11 Protocol Section 10.9 Interim Analyses C218649 C217272 Protocol Section Name and Number Response Terminology 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS 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 C218650 C217272 Protocol Section Name and Number Response Terminology 11.1 Regulatory and Ethical Considerations Section 11.1 of the ICH M11 Protocol standard, Regulatory and Ethical Considerations. ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations C218663 C217272 Protocol Section Name and Number Response Terminology 11.10 Protocol Deviations Section 11.10 of the ICH M11 Protocol standard, Protocol Deviations. ICH M11 Protocol Section 11.10 Protocol Deviations C218664 C217272 Protocol Section Name and Number Response Terminology 11.11 Early Site Closure Section 11.11 of the ICH M11 Protocol standard, Early Site Closure. ICH M11 Protocol Section 11.11 Early Site Closure C218665 C217272 Protocol Section Name and Number Response Terminology 11.12 Data Dissemination Section 11.12 of the ICH M11 Protocol standard, Data Dissemination. ICH M11 Protocol Section 11.12 Data Dissemination C218651 C217272 Protocol Section Name and Number Response Terminology 11.2 Trial Oversight Section 11.2 of the ICH M11 Protocol standard, Trial Oversight. ICH M11 Protocol Section 11.2 Trial Oversight C218652 C217272 Protocol Section Name and Number Response Terminology 11.2.1 Investigator Responsibilities Section 11.2.1 of the ICH M11 Protocol standard, Investigator Responsibilities. ICH M11 Protocol Section 11.2.1 Investigator Responsibilities C218653 C217272 Protocol Section Name and Number Response Terminology 11.2.2 Sponsor Responsibilities Section 11.2.2 of the ICH M11 Protocol standard, Sponsor Responsibilities. ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities C218654 C217272 Protocol Section Name and Number Response Terminology 11.3 Informed Consent Process Section 11.3 of the ICH M11 Protocol standard, Informed Consent Process. ICH M11 Protocol Section 11.3 Informed Consent Process C218655 C217272 Protocol Section Name and Number Response Terminology 11.3.1 Informed Consent for Rescreening 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 C218656 C217272 Protocol Section Name and Number Response Terminology 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research 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 C218657 C217272 Protocol Section Name and Number Response Terminology 11.4 Committees Section 11.4 of the ICH M11 Protocol standard, Committees. ICH M11 Protocol Section 11.4 Committees C218658 C217272 Protocol Section Name and Number Response Terminology 11.5 Insurance and Indemnity Section 11.5 of the ICH M11 Protocol standard, Insurance and Indemnity. ICH M11 Protocol Section 11.5 Insurance and Indemnity C218659 C217272 Protocol Section Name and Number Response Terminology 11.6 Risk-Based Quality Management Section 11.6 of the ICH M11 Protocol standard, Risk-Based Quality Management. ICH M11 Protocol Section 11.6 Risk-Based Quality Management C218660 C217272 Protocol Section Name and Number Response Terminology 11.7 Data Governance Section 11.7 of the ICH M11 Protocol standard, Data Governance. ICH M11 Protocol Section 11.7 Data Governance C218661 C217272 Protocol Section Name and Number Response Terminology 11.8 Data Protection Section 11.8 of the ICH M11 Protocol standard, Data Protection. ICH M11 Protocol Section 11.8 Data Protection C218662 C217272 Protocol Section Name and Number Response Terminology 11.9 Source Records Section 11.9 of the ICH M11 Protocol standard, Source Records. ICH M11 Protocol Section 11.9 Source Records C218666 C217272 Protocol Section Name and Number Response Terminology 12 APPENDIX: SUPPORTING DETAILS Section 12 of the ICH M11 Protocol standard, APPENDIX: SUPPORTING DETAILS. ICH M11 Protocol Section 12 APPENDIX: SUPPORTING DETAILS C218667 C217272 Protocol Section Name and Number Response Terminology 12.1 Clinical Laboratory Tests Section 12.1 of the ICH M11 Protocol standard, Clinical Laboratory Tests. ICH M11 Protocol Section 12.1 Clinical Laboratory Tests C218668 C217272 Protocol Section Name and Number Response Terminology 12.2 Country/Region-Specific Differences Section 12.2 of the ICH M11 Protocol standard, Country/Region-Specific Differences. ICH M11 Protocol Section 12.2 Country/Region-Specific Differences C218669 C217272 Protocol Section Name and Number Response Terminology 12.3 Prior Protocol Amendment(s) Section 12.3 of the ICH M11 Protocol standard, Prior Protocol Amendment(s). ICH M11 Protocol Section 12.3 Prior Protocol Amendment(s) C218670 C217272 Protocol Section Name and Number Response Terminology 13 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS 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 C218671 C217272 Protocol Section Name and Number Response Terminology 14 APPENDIX: REFERENCES Section 14 of the ICH M11 Protocol standard, APPENDIX: REFERENCES. ICH M11 Protocol Section 14 APPENDIX: REFERENCES C218520 C217272 Protocol Section Name and Number Response Terminology 2 INTRODUCTION Section 2 of the ICH M11 Protocol standard, INTRODUCTION. ICH M11 Protocol Section 2 INTRODUCTION C218521 C217272 Protocol Section Name and Number Response Terminology 2.1 Purpose of Trial Section 2.1 of the ICH M11 Protocol standard, Purpose of Trial. ICH M11 Protocol Section 2.1 Purpose of Trial C218522 C217272 Protocol Section Name and Number Response Terminology 2.2 Assessment of Risks and Benefits 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 C218523 C217272 Protocol Section Name and Number Response Terminology 2.2.1 Risk Summary and Mitigation Strategy 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 C218524 C217272 Protocol Section Name and Number Response Terminology 2.2.2 Benefit Summary Section 2.2.1 of the ICH M11 Protocol standard, Benefit Summary. ICH M11 Protocol Section 2.2.2 Benefit Summary C218525 C217272 Protocol Section Name and Number Response Terminology 2.2.3 Overall Risk-Benefit Assessment 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 C218526 C217272 Protocol Section Name and Number Response Terminology 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS Section 3 of the ICH M11 Protocol standard, TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS. ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS C218527 C217272 Protocol Section Name and Number Response Terminology 3.1 Primary Objective(s) and Associated Estimand(s) 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) C218528 C217272 Protocol Section Name and Number Response Terminology 3.1.1 Primary Objective Section 3.1.1 of the ICH M11 Protocol standard, Primary Objective. ICH M11 Protocol Section 3.1.1 Primary Objective C218529 C217272 Protocol Section Name and Number Response Terminology 3.2 Secondary Objective(s) and Associated Estimand(s) 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) C218530 C217272 Protocol Section Name and Number Response Terminology 3.2.1 Secondary Objective Section 3.2.1 of the ICH M11 Protocol standard, Secondary Objective. ICH M11 Protocol Section 3.2.1 Secondary Objective C218531 C217272 Protocol Section Name and Number Response Terminology 3.3 Exploratory Objective(s) Section 3.3 of the ICH M11 Protocol standard, Exploratory Objective(s). ICH M11 Protocol Section 3.3 Exploratory Objective(s) C218532 C217272 Protocol Section Name and Number Response Terminology 3.3.1 Exploratory Objective Section 3.3.1 of the ICH M11 Protocol standard, Exploratory Objective. ICH M11 Protocol Section 3.3.1 Exploratory Objective C218533 C217272 Protocol Section Name and Number Response Terminology 4 TRIAL DESIGN Section 4 of the ICH M11 Protocol standard, TRIAL DESIGN. ICH M11 Protocol Section 4 TRIAL DESIGN C218534 C217272 Protocol Section Name and Number Response Terminology 4.1 Description of 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 C218535 C217272 Protocol Section Name and Number Response Terminology 4.1.1 Stakeholder Input into 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 C218536 C217272 Protocol Section Name and Number Response Terminology 4.2 Rationale for Trial Design Section 4.2 of the ICH M11 Protocol standard, Rationale for Trial Design. ICH M11 Protocol Section 4.2 Rationale for Trial Design C218537 C217272 Protocol Section Name and Number Response Terminology 4.2.1 Rationale for Estimand(s) 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) C218538 C217272 Protocol Section Name and Number Response Terminology 4.2.2 Rationale for Intervention Model 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 C218539 C217272 Protocol Section Name and Number Response Terminology 4.2.3 Rationale for Control Type 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 C218540 C217272 Protocol Section Name and Number Response Terminology 4.2.4 Rationale for Trial Duration 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 C218541 C217272 Protocol Section Name and Number Response Terminology 4.2.5 Rationale for Adaptive or Novel Trial Design 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 C218542 C217272 Protocol Section Name and Number Response Terminology 4.2.6 Rationale for Interim Analysis 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 C218543 C217272 Protocol Section Name and Number Response Terminology 4.2.7 Rationale for Other Trial Design Aspects 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 C218544 C217272 Protocol Section Name and Number Response Terminology 4.3 Trial Stopping Rules Section 4.3 of the ICH M11 Protocol standard, Trial Stopping Rules. ICH M11 Protocol Section 4.3 Trial Stopping Rules C218545 C217272 Protocol Section Name and Number Response Terminology 4.4 Start of Trial and End of Trial 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 C218546 C217272 Protocol Section Name and Number Response Terminology 4.5 Access to Trial Intervention After 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 C218547 C217272 Protocol Section Name and Number Response Terminology 5 TRIAL POPULATION Section 5 of the ICH M11 Protocol standard, TRIAL POPULATION. ICH M11 Protocol Section 5 TRIAL POPULATION C218548 C217272 Protocol Section Name and Number Response Terminology 5.1 Description of Trial Population and Rationale 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 C218549 C217272 Protocol Section Name and Number Response Terminology 5.2 Inclusion Criteria Section 5.2 of the ICH M11 Protocol standard, Inclusion Criteria. ICH M11 Protocol Section 5.2 Inclusion Criteria C218550 C217272 Protocol Section Name and Number Response Terminology 5.3 Exclusion Criteria Section 5.3 of the ICH M11 Protocol standard, Exclusion Criteria. ICH M11 Protocol Section 5.3 Exclusion Criteria C218551 C217272 Protocol Section Name and Number Response Terminology 5.4 Contraception Section 5.4 of the ICH M11 Protocol standard, Contraception. ICH M11 Protocol Section 5.4 Contraception C218552 C217272 Protocol Section Name and Number Response Terminology 5.4.1 Definitions Related to Childbearing Potential 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 C218553 C217272 Protocol Section Name and Number Response Terminology 5.4.2 Contraception Requirements Section 5.4.2 of the ICH M11 Protocol standard, Contraception Requirements. ICH M11 Protocol Section 5.4.2 Contraception Requirements C218554 C217272 Protocol Section Name and Number Response Terminology 5.5 Lifestyle Restrictions Section 5.5 of the ICH M11 Protocol standard, Lifestyle Restrictions. ICH M11 Protocol Section 5.5 Lifestyle Restrictions C218555 C217272 Protocol Section Name and Number Response Terminology 5.5.1 Meals and Dietary 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 C218556 C217272 Protocol Section Name and Number Response Terminology 5.5.2 Caffeine, Alcohol, Tobacco, and Other 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 C218557 C217272 Protocol Section Name and Number Response Terminology 5.5.3 Physical Activity Restrictions Section 5.5.3 of the ICH M11 Protocol standard, Physical Activity Restrictions. ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions C218558 C217272 Protocol Section Name and Number Response Terminology 5.5.4 Other 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 C218559 C217272 Protocol Section Name and Number Response Terminology 5.6 Screen Failure and Rescreening Section 5.6 of the ICH M11 Protocol standard, Screen Failure and Rescreening. ICH M11 Protocol Section 5.6 Screen Failure and Rescreening C218560 C217272 Protocol Section Name and Number Response Terminology 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY Section 6 of the ICH M11 Protocol standard, TRIAL INTERVENTION AND CONCOMITANT THERAPY. ICH M11 Protocol Section 6 TRIAL INTERVENTION AND CONCOMITANT THERAPY C218561 C217272 Protocol Section Name and Number Response Terminology 6.1 Description of Investigational Trial Intervention 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 C218580 C217272 Protocol Section Name and Number Response Terminology 6.10 Concomitant Therapy Section 6.10 of the ICH M10 Protocol standard, Concomitant Therapy. ICH M11 Protocol Section 6.10 Concomitant Therapy C218581 C217272 Protocol Section Name and Number Response Terminology 6.10.1 Prohibited 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 C218582 C217272 Protocol Section Name and Number Response Terminology 6.10.2 Permitted 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 C218562 C217272 Protocol Section Name and Number Response Terminology 6.2 Rationale for Investigational Trial Intervention Dose and Regimen 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 C218563 C217272 Protocol Section Name and Number Response Terminology 6.3 Investigational Trial Intervention Administration Section 6.3 of the ICH M11 Protocol standard, Investigational Trial Intervention Administration. ICH M11 Protocol Section 6.3 Investigational Trial Intervention Administration C218564 C217272 Protocol Section Name and Number Response Terminology 6.4 Investigational Trial Intervention Dose Modification 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 C218565 C217272 Protocol Section Name and Number Response Terminology 6.5 Management of Investigational Trial Intervention Overdose 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 C218566 C217272 Protocol Section Name and Number Response Terminology 6.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention 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 C218567 C217272 Protocol Section Name and Number Response Terminology 6.6.1 Preparation 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 C218568 C217272 Protocol Section Name and Number Response Terminology 6.6.2 Storage and Handling 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 C218569 C217272 Protocol Section Name and Number Response Terminology 6.6.3 Accountability 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 C218570 C217272 Protocol Section Name and Number Response Terminology 6.7 Investigational Trial Intervention Assignment, Randomisation and Blinding 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 C218571 C217272 Protocol Section Name and Number Response Terminology 6.7.1 Participant Assignment to Investigational Trial Intervention 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 C218572 C217272 Protocol Section Name and Number Response Terminology 6.7.2 Randomisation Section 6.7.2 of the ICH M11 Protocol standard, Randomisation. ICH M11 Protocol Section 6.7.2 Randomisation C218573 C217272 Protocol Section Name and Number Response Terminology 6.7.3 Measures to Maintain Blinding 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 C218574 C217272 Protocol Section Name and Number Response Terminology 6.7.4 Emergency Unblinding at the Site 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 C218575 C217272 Protocol Section Name and Number Response Terminology 6.8 Investigational Trial Intervention Adherence Section 6.8 of the ICH M11 Protocol standard, Investigational Trial Intervention Adherence. ICH M11 Protocol Section 6.8 Investigational Trial Intervention Adherence C218576 C217272 Protocol Section Name and Number Response Terminology 6.9 Description of Noninvestigational Trial Intervention 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 C218577 C217272 Protocol Section Name and Number Response Terminology 6.9.1 Background 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 C218578 C217272 Protocol Section Name and Number Response Terminology 6.9.2 Rescue Therapy Section 6.9.2 of the ICH M11 Protocol standard, Rescue Therapy. ICH M11 Protocol Section 6.9.2 Rescue Therapy C218579 C217272 Protocol Section Name and Number Response Terminology 6.9.3 Other Noninvestigational Trial Intervention 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 C218583 C217272 Protocol Section Name and Number Response Terminology 7 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL 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 C218584 C217272 Protocol Section Name and Number Response Terminology 7.1 Discontinuation of Trial Intervention for Individual Participants 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 C218585 C217272 Protocol Section Name and Number Response Terminology 7.1.1 Permanent Discontinuation of Trial Intervention 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 C218586 C217272 Protocol Section Name and Number Response Terminology 7.1.2 Temporary 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 C218587 C217272 Protocol Section Name and Number Response Terminology 7.1.3 Rechallenge Section 7.1.3 of the ICH M11 Protocol standard, Rechallenge. ICH M11 Protocol Section 7.1.3 Rechallenge C218588 C217272 Protocol Section Name and Number Response Terminology 7.2 Participant Discontinuation or Withdrawal from the Trial 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 C218589 C217272 Protocol Section Name and Number Response Terminology 7.3 Management of Loss to Follow-Up 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 C218590 C217272 Protocol Section Name and Number Response Terminology 8 TRIAL ASSESSMENTS AND PROCEDURES Section 8 of the ICH M11 Protocol standard, TRIAL ASSESSMENTS AND PROCEDURES. ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES C218591 C217272 Protocol Section Name and Number Response Terminology 8.1 Trial Assessments and Procedures Considerations 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 C218592 C217272 Protocol Section Name and Number Response Terminology 8.2 Screening/Baseline Assessments and Procedures 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 C218593 C217272 Protocol Section Name and Number Response Terminology 8.3 Efficacy 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 C218594 C217272 Protocol Section Name and Number Response Terminology 8.4 Safety 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 C218595 C217272 Protocol Section Name and Number Response Terminology 8.4.1 Physical Examination Section 8.4.1 of the ICH M11 Protocol standard, Physical Examination. ICH M11 Protocol Section 8.4.1 Physical Examination C218596 C217272 Protocol Section Name and Number Response Terminology 8.4.2 Vital Signs Section 8.4.2 of the ICH M11 Protocol standard, Vital Signs. ICH M11 Protocol Section 8.4.2 Vital Signs C218597 C217272 Protocol Section Name and Number Response Terminology 8.4.3 Electrocardiograms Section 8.4.3 of the ICH M11 Protocol standard, Electrocardiograms. ICH M11 Protocol Section 8.4.3 Electrocardiograms C218598 C217272 Protocol Section Name and Number Response Terminology 8.4.4 Clinical Laboratory Assessments Section 8.4.4 of the ICH M11 Protocol standard, Clinical Laboratory Assessments. ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments C218599 C217272 Protocol Section Name and Number Response Terminology 8.4.5 Pregnancy Testing Section 8.4.5 of the ICH M11 Protocol standard, Pregnancy Testing. ICH M11 Protocol Section 8.4.5 Pregnancy Testing C218600 C217272 Protocol Section Name and Number Response Terminology 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring 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 C218601 C217272 Protocol Section Name and Number Response Terminology 8.5 Pharmacokinetics Section 8.5 of the ICH M11 Protocol standard, Pharmacokinetics. ICH M11 Protocol Section 8.5 Pharmacokinetics C218602 C217272 Protocol Section Name and Number Response Terminology 8.6 Biomarkers Section 8.6 of the ICH M11 Protocol standard, Biomarkers. ICH M11 Protocol Section 8.6 Biomarkers C218603 C217272 Protocol Section Name and Number Response Terminology 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics 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 C218604 C217272 Protocol Section Name and Number Response Terminology 8.6.2 Pharmacodynamic Biomarkers Section 8.6.2 of the ICH M11 Protocol standard, Pharmacodynamic Biomarkers. ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers C218605 C217272 Protocol Section Name and Number Response Terminology 8.6.3 Other Biomarkers Section 8.6.3 of the ICH M11 Protocol standard, Other Biomarkers. ICH M11 Protocol Section 8.6.3 Other Biomarkers C218606 C217272 Protocol Section Name and Number Response Terminology 8.7 Immunogenicity Assessments Section 8.7 of the ICH M11 Protocol standard, Immunogenicity Assessments. ICH M11 Protocol Section 8.7 Immunogenicity Assessments C218607 C217272 Protocol Section Name and Number Response Terminology 8.8 Medical Resource Utilisation and Health Economics 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 C218608 C217272 Protocol Section Name and Number Response Terminology 9 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS 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 C218609 C217272 Protocol Section Name and Number Response Terminology 9.1 Definitions Section 9.1 of the ICH M11 Protocol standard, Definitions. ICH M11 Protocol Section 9.1 Definitions C218610 C217272 Protocol Section Name and Number Response Terminology 9.1.1 Definitions of Adverse Events 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 C218611 C217272 Protocol Section Name and Number Response Terminology 9.1.2 Definitions of Serious 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 C218612 C217272 Protocol Section Name and Number Response Terminology 9.1.3 Definitions of Product Complaints 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 C218613 C217272 Protocol Section Name and Number Response Terminology 9.1.3.1 Definitions of Medical Device 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 C218614 C217272 Protocol Section Name and Number Response Terminology 9.2 Timing and Procedures for Collection and Reporting 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 C218615 C217272 Protocol Section Name and Number Response Terminology 9.2.1 Timing Section 9.2.1 of the ICH M11 Protocol standard, Timing. ICH M11 Protocol Section 9.2.1 Timing C218616 C217272 Protocol Section Name and Number Response Terminology 9.2.2 Collection Procedures Section 9.2.2 of the ICH M11 Protocol standard, Collection Procedures. ICH M11 Protocol Section 9.2.2 Collection Procedures C218617 C217272 Protocol Section Name and Number Response Terminology 9.2.3 Reporting Section 9.2.3 of the ICH M11 Protocol standard, Reporting. ICH M11 Protocol Section 9.2.3 Reporting C218618 C217272 Protocol Section Name and Number Response Terminology 9.2.3.1 Regulatory Reporting Requirements 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 C218619 C217272 Protocol Section Name and Number Response Terminology 9.2.4 Adverse Events of Special Interest 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 C218620 C217272 Protocol Section Name and Number Response Terminology 9.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs 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 C218621 C217272 Protocol Section Name and Number Response Terminology 9.3 Pregnancy and Postpartum Information Section 9.3 of the ICH M11 Protocol standard, Pregnancy and Postpartum Information. ICH M11 Protocol Section 9.3 Pregnancy and Postpartum Information C218622 C217272 Protocol Section Name and Number Response Terminology 9.3.1 Participants Who Become Pregnant During the Trial 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 C218623 C217272 Protocol Section Name and Number Response Terminology 9.3.2 Participants Whose Partners 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 C218624 C217272 Protocol Section Name and Number Response Terminology 9.4 Special Safety Situations Section 9.4 of the ICH M11 Protocol standard, Special Safety Situations. ICH M11 Protocol Section 9.4 Special Safety Situations C222770 C217272 Protocol Section Name and Number Response Terminology Amendment Details Amendment Details Section of the ICH M11 Protocol standard, Amendment Details. ICH M11 Protocol Section Amendment Details C222769 C217272 Protocol Section Name and Number Response Terminology Title Page Title Page Section of the ICH M11 Protocol standard, Title Page. ICH M11 Protocol Section Title Page C217276 No Reason for Amendment Response Terminology Reason for Amendment Response Terminology Reason for Amendment Response Terminology A valid value set relevant to the reason for amendment responses within the ICH M11 protocol template. ICH M11 Reason for Amendment Value Set Terminology C218497 C217276 Reason for Amendment Response Terminology Change In Standard Of Care 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 C218496 C217276 Reason for Amendment Response Terminology Change In Strategy 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 C218495 C217276 Reason for Amendment Response Terminology IMP Addition 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 C218501 C217276 Reason for Amendment Response Terminology Inconsistency And/Or Error In The Protocol 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 C218499 C217276 Reason for Amendment Response Terminology Investigator/Site Feedback Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol. Investigator/Site Feedback Amendment Reason C218492 C217276 Reason for Amendment Response Terminology IRB/IEC Feedback 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 C218494 C217276 Reason for Amendment Response Terminology Manufacturing Change A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol. Manufacturing Change Amendment Reason C218498 C217276 Reason for Amendment Response Terminology New Data Available (Other Than Safety Data) 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 C218491 C217276 Reason for Amendment Response Terminology New Regulatory Guidance 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 C218493 C217276 Reason for Amendment Response Terminology New Safety Information Available Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol. New Safety Information Available Amendment Reason C48660 C217276 Reason for Amendment Response Terminology Not Applicable Determination of a value is not relevant in the current context. Not Applicable C17649 C217276 Reason for Amendment Response Terminology Other Different than the one(s) previously specified or mentioned. Other C218502 C217276 Reason for Amendment Response Terminology Protocol Design Error A protocol design error necessitates a change(s) to, or formal clarification of, a document. Protocol Design Error Amendment Reason C218500 C217276 Reason for Amendment Response Terminology Recruitment Difficulty Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol. Recruitment Difficulty Amendment Reason C218490 C217276 Reason for Amendment Response Terminology Regulatory Agency Request To Amend 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 C217283 No Trial Arm Type Response Terminology Trial Arm Type Response Terminology Trial Arm Type Response Terminology A valid value set relevant to the trial arm type responses within the ICH M11 protocol template. ICH M11 Trial Arm Type Value Set Terminology C174267 C217283 Trial Arm Type Response Terminology Active Comparator Arm An arm describing the active comparator. Active Comparator Arm C174226 C217283 Trial Arm Type Response Terminology Control 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 C174266 C217283 Trial Arm Type Response Terminology Experimental Arm An arm describing the intervention or treatment plan for a group of participants in the study receiving test product(s). Investigational Arm C174270 C217283 Trial Arm Type Response Terminology No Intervention Arm A study arm without an intervention or treatment. No Intervention Arm C174268 C217283 Trial Arm Type Response Terminology Placebo Comparator Arm An arm describing the placebo comparator. Placebo Control Arm C174269 C217283 Trial Arm Type Response Terminology Sham Comparator Arm An arm describing the sham comparator. Sham Comparator Arm C217281 No Trial Blinding Role Response Terminology Trial Blinding Role Response Terminology Trial Blinding Role Response Terminology A valid value set relevant to the trial blinding role responses within the ICH M11 protocol template. ICH M11 Trial Blinding Role Value Set Terminology C17445 C217281 Trial Blinding Role Response Terminology Care Provider The primary person in charge of the care of a patient, usually a family member or a designated health care professional. Caregiver C25936 C217281 Trial Blinding Role Response Terminology Investigator 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 C48660 C217281 Trial Blinding Role Response Terminology Not Applicable Determination of a value is not relevant in the current context. Not Applicable C207599 C217281 Trial Blinding Role Response Terminology Outcomes Assessor The individual who evaluates the outcome(s) of interest. Outcomes Assessor C142710 C217281 Trial Blinding Role Response Terminology Participant A member of the clinical study population from whom data are being collected. (CDISC Glossary) Study Participant C70793 C217281 Trial Blinding Role Response Terminology Sponsor 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 C217051 No Trial Blinding Schema Response Terminology Trial Blinding Schema Response Terminology Trial Blinding Schema Response Terminology Terminology associated with the trial blind schema value set codelist of the ICH M11 protocol template. ICH M11 Trial Blind Schema Value Set Terminology C15228 C217051 Trial Blinding Schema Response Terminology Double Blind 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 C187674 C217051 Trial Blinding Schema Response Terminology Observer Blind 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 C49659 C217051 Trial Blinding Schema Response Terminology Open Label A study in which participants and study personnel know which intervention each participant is receiving. Open Label Study C28233 C217051 Trial Blinding Schema Response Terminology Single Blind 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 C217280 No Trial Intervention Assignment Method Response Terminology Trial Intervention Assignment Method Response Terminology Trial Intervention Assignment Method Response Terminology A valid value set relevant to the trial intervention assignment method responses within the ICH M11 protocol template. ICH M11 Trial Intervention Assignment Method Value Set Terminology C222801 C217280 Trial Intervention Assignment Method Response Terminology No Intervention Assignment Method No specific methodology is used to assign trial participants to treatment or control groups. No Intervention Assignment Method C17649 C217280 Trial Intervention Assignment Method Response Terminology Other Different than the one(s) previously specified or mentioned. Other C25196 C217280 Trial Intervention Assignment Method Response Terminology Randomisation 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 C217045 No Trial Phase Response Terminology Trial Phase Response Terminology Trial Phase Response Terminology Terminology associated with the trial phase value set codelist of the ICH M11 protocol template. ICH M11 Trial Phase Value Set Terminology C54721 C217045 Trial Phase Response Terminology Early Phase 1 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 C15600 C217045 Trial Phase Response Terminology Phase 1 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 C15693 C217045 Trial Phase Response Terminology Phase 1/Phase 2 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 C198366 C217045 Trial Phase Response Terminology Phase 1/Phase 2/Phase 3 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 C198367 C217045 Trial Phase Response Terminology Phase 1/Phase 3 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 C15601 C217045 Trial Phase Response Terminology Phase 2 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 C15694 C217045 Trial Phase Response Terminology Phase 2/Phase 3 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 C217024 C217045 Trial Phase Response Terminology Phase 2/Phase 3/Phase 4 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 C15602 C217045 Trial Phase Response Terminology Phase 3 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 C217025 C217045 Trial Phase Response Terminology Phase 3/Phase 4 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 C15603 C217045 Trial Phase Response Terminology Phase 4 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 C217049 No Trial Site Distribution Response Terminology Trial Site Distribution Response Terminology Trial Site Distribution Response Terminology Terminology associated with the site distribution value set codelist of the ICH M11 protocol template. ICH M11 Trial Site Distribution Value Set Terminology C217005 C217049 Trial Site Distribution Response Terminology Multicentre 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 C217004 C217049 Trial Site Distribution Response Terminology Single-Centre A clinical trial that is conducted at a single site. Single-Center Study C217050 No Trial Site Geographic Scope Response Terminology Trial Site Geographic Scope Response Terminology Trial Site Geographic Scope Response Terminology Terminology associated with the site geographic scope value set codelist of the ICH M11 protocol template. ICH M11 Trial Site Geographic Scope Value Set Terminology C217007 C217050 Trial Site Geographic Scope Response Terminology Multiple Countries Of, or pertaining to, an occurrence in more than one country. Multiple Countries C217006 C217050 Trial Site Geographic Scope Response Terminology Single Country Of, or pertaining to, an occurrence in one country. Single Country C217287 No Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology Trial-Related Safety Event Type Response Terminology A valid value set relevant to the trial-related safety event type responses within the ICH M11 protocol template. ICH M11 Trial-Related Safety Event Type Value Set Terminology C41331 C217287 Trial-Related Safety Event Type Response Terminology Adverse Event 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 C222331 C217287 Trial-Related Safety Event Type Response Terminology Drug/Device Combination Product Complaint Any concern about the safety, quality, and/or performance of a trial-related drug-device combination. Drug-Device Combination Product Complaint C218510 C217287 Trial-Related Safety Event Type Response Terminology Lactation Event Any event that occurs when the participant is lactating. Lactation Event C218513 C217287 Trial-Related Safety Event Type Response Terminology Not Reportable Adverse Event of Special Interest 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 C17649 C217287 Trial-Related Safety Event Type Response Terminology Other Different than the one(s) previously specified or mentioned. Other C218511 C217287 Trial-Related Safety Event Type Response Terminology Post-Partum Event Any event that occurs when the participant is in the stages of recovery post pregnancy and birth event. Post-Partum Event C218509 C217287 Trial-Related Safety Event Type Response Terminology Pregnancy Event Any event that occurs when the participant or participant's partner becomes pregnant or is pregnant. Pregnancy Event C218512 C217287 Trial-Related Safety Event Type Response Terminology Reportable Adverse Event of Special Interest 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 C41335 C217287 Trial-Related Safety Event Type Response Terminology Serious Adverse Event 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 C218508 C217287 Trial-Related Safety Event Type Response Terminology Trial Intervention Complaint Any concern about the safety and/or quality of any trial-related interventions. Trial Intervention Complaint C217048 No Unit of Measure Terminology Unit of Measure Terminology Unit of Measure Terminology Terminology associated with the units of measure value set codelist of the ICH M11 protocol template. ICH M11 Units of Measure Value Set Terminology C25301 C217048 Unit of Measure Terminology Days A unit of measurement of time equal to 24 hours. Day C25529 C217048 Unit of Measure Terminology Hours A unit of measurement of time equal to 60 minutes. Hour C29846 C217048 Unit of Measure Terminology Months 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 C29844 C217048 Unit of Measure Terminology Weeks Any period of seven consecutive days. Week C29848 C217048 Unit of Measure Terminology Years 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