<custodian> <reference value="Organization/118079"/> <type value="Organization"/> <display value="Computable Publishing LLC"/> </custodian> <relatesTo> <type value="derived-from"/> <targetReference> <reference value="ResearchStudy/568025"/> <type value="ResearchStudy"/> <display value="M11ResearchStudy Template"/> </targetReference> </relatesTo> <relatesTo> <type value="cite-as"/> <targetMarkdown value="M11 Report Section 5 (Trial Population) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568047. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568047. Computable resource at: https://fevir.net/resources/Composition/568047#json."/> </relatesTo> <section> <title value="Trial Population"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218547"/> <display value="ICH M11 Protocol Section 5 TRIAL POPULATION"/> </coding> <text value="section5-trial-population"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[No text is intended here (heading only).]</div> </text> <section> <title value="Description of Trial Population and Rationale"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218548"/> <display value="ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale"/> </coding> <text value="section5.1-population-description"/> </code> <text> <status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml">This instance of StudyEligibilityCriteria Profile is used as an example of structured eligibility criteria in support of creation of a set of Composition Profiles to represent the M11 Report Template Instructions. Inclusion Criteria: 1. inclusion criterion 1 2. inclusion criterion 2 Exclusion Criteria: 1. exclusion criterion 1 2. exclusion criterion 2 [Describe the population selected (e.g., healthy participants, adult participants, paediatric participants, pregnant participants, or breastfeeding participants) and how the enrollment criteria reflect the populations that are likely to use the drug if approved. Specify the population age range (e.g., ≤3 months, ≥18 to ≤80 years old) including the time point at which qualification for age criteria is determined (e.g., at time of screening vs randomisation for paediatric trials). Specify any key diagnostic criteria for the population (e.g., “acute lung injury”, or a specific biomarker profile). If applicable, describe similar conditions or diseases and their differential diagnosis. Provide a rationale for the trial population ensuring that the population selected is well defined and clinically recognisable. Describe how the selected population can meet the trial objectives and how the enrollment criteria reflect the population of interest. If the population targeted by a clinical question is based on a subset of the entire trial population, e.g., defined by a particular characteristic measured at baseline (e.g., a specific biomarker), this subset should be justified in this section. Justify whether the trial intervention is to be evaluated in paediatric participants, in adults unable to consent for themselves, other vulnerable participant populations, or those that may respond to the trial intervention differently (e.g., elderly, hepatic or renally impaired, or immunocompromised participants).]</div> </text> <entry> <reference value="Group/568026"/> <type value="Group"/> <display value="StudyEligibilityCriteria for M11Report Example"/> </entry> </section> <section> <title value="Inclusion Criteria"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218549"/> <display value="ICH M11 Protocol Section 5.2 Inclusion Criteria"/> </coding> <text value="section5.2-inclusion-criteria"/> </code> <text> <status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml"><p>1. <b>Characteristic: </b>1. inclusion criterion 1; <b>Defined as: </b>Defined by CodeableConcept matching value of 1. inclusion criterion 1</p><p>2. <b>Characteristic: </b>2. inclusion criterion 2; <b>Defined as: </b>Defined by CodeableConcept matching value of 2. inclusion criterion 2</p><p>3. <b>Characteristic: </b> matching value of </p></div> </text> <entry> <reference value="Group/568026"/> <type value="Group"/> <display value="StudyEligibilityCriteria for M11Report Example"/> </entry> </section> <section> <title value="Exclusion Criteria"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218550"/> <display value="ICH M11 Protocol Section 5.3 Exclusion Criteria"/> </coding> <text value="section5.3-exclusion-criteria"/> </code> <text> <status value="generated"/><div xmlns="http://www.w3.org/1999/xhtml"><p>1. <b>Characteristic: </b>1. exclusion criterion 1; <b>Defined as: </b>Defined by CodeableConcept matching value of 1. exclusion criterion 1</p><p>2. <b>Characteristic: </b>2. exclusion criterion 2; <b>Defined as: </b>Defined by CodeableConcept matching value of 2. exclusion criterion 2</p></div> </text> <entry> <reference value="Group/568026"/> <type value="Group"/> <display value="StudyEligibilityCriteria for M11Report Example"/> </entry> </section> <section> <title value="Contraception"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218551"/> <display value="ICH M11 Protocol Section 5.4 Contraception"/> </coding> <text value="section5.4-contraception"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[No text is intended here (heading only).]</div> </text> <section> <title value="Definitions Related to Childbearing Potential"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218552"/> <display value="ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential"/> </coding> <text value="section5.4.1-contraception-definitions"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Specify the definitions of: • participant of childbearing potential, and • participant of nonchildbearing potential]</div> </text> </section> <section> <title value="Contraception Requirements"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218553"/> <display value="ICH M11 Protocol Section 5.4.2 Contraception Requirements"/> </coding> <text value="section5.4.2-contraception-details"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Specify the: • contraceptive methods required, and • duration of use]</div> </text> </section> </section> <section> <title value="Lifestyle Restrictions"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218554"/> <display value="ICH M11 Protocol Section 5.5 Lifestyle Restrictions"/> </coding> <text value="section5.5-lifestyle-restrictions"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[In the following subsections, describe any restrictions during the trial pertaining to lifestyle and/or diet, intake of caffeine, alcohol, or tobacco, or physical and other activities. If not applicable, include a statement that no restrictions are required.]</div> </text> <section> <title value="Meals and Dietary Restrictions"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218555"/> <display value="ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions"/> </coding> <text value="section5.5.1-dietary-restrictions"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[If applicable, describe any restrictions on diet (for example, food and drink restrictions, timing of meals relative to dosing, etc.).]</div> </text> </section> <section> <title value="Caffeine, Alcohol, Tobacco, and Other Restrictions"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218556"/> <display value="ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions"/> </coding> <text value="section5.5.2-substances-restrictions"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[If applicable, describe any restrictions on the intake of caffeine, alcohol, tobacco, or other restrictions.]</div> </text> </section> <section> <title value="Physical Activity Restrictions"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218557"/> <display value="ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions"/> </coding> <text value="section5.5.3-activity-restrictions"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[If applicable, describe any restrictions on activity (for example, in first-in-human trials, activity may be restricted by ensuring participants remain in bed for 4 to 6 hours after dosing).]</div> </text> </section> <section> <title value="Other Activity Restrictions"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218558"/> <display value="ICH M11 Protocol Section 5.5.4 Other Activity Restrictions"/> </coding> <text value="section5.5.4-other-restrictions"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[If applicable, describe restrictions on any other activity (for example, blood or tissue donation, driving, heavy machinery use, or sun exposure).]</div> </text> </section> </section> <section> <title value="Screen Failure and Rescreening"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218559"/> <display value="ICH M11 Protocol Section 5.6 Screen Failure and Rescreening"/> </coding> <text value="section5.6-screen-failure"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Describe screen failure and indicate how screen failure will be handled in the trial, including conditions and criteria upon which rescreening is acceptable. If applicable, indicate the circumstances and time window under which a repeat procedure is allowed for screen failure relating to specific inclusion/exclusion criteria for the trial.]</div> </text> </section> </section> </Composition>

Generated Narrative: Composition 568047

version: 2; Last updated: 2026-05-30 18:25:49+0000

Profile: M11ReportSection05

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Composition/568047

identifier: FEvIR Object Identifier/568047

status: Final

type: CeSHarP Report

category: section5-trial-population

date: 2026-05-30 18:25:49+0000

author: Brian S. Alper, MD, MSPH

title: M11 Report Section 5 (Trial Population) for M11ResearchStudy Template

custodian: Computable Publishing LLC

relatesTo
type: Derived From
target: M11ResearchStudy Template

relatesTo
type: Cite As
target:
M11 Report Section 5 (Trial Population) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568047. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568047. Computable resource at: https://fevir.net/resources/Composition/568047#json.