FHIR IG analytics| Package | hl7.fhir.uv.ebm |
| Resource Type | Composition |
| Id | Composition-568047.json |
| FHIR Version | R6 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: Composition 568047
version: 5; Last updated: 2026-06-07 13:55:33+0000
Profile: M11ReportSection05
Artifact Description:
Example of M11ReportSection05 Profile
ArtifactPublicationStatus: Active
url: https://fevir.net/resources/Composition/568047
identifier: FEvIR Object Identifier/568047
status: Final
type: CeSHarP Report
category: section5-trial-population
date: 2026-06-07 13:55:33+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 2026-06-07. Available at: https://fevir.net/resources/Composition/568047. Computable resource at: https://fevir.net/resources/Composition/568047#json.
FHIR
FHIRsmith{
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"id": "568047",
"meta": {
"versionId": "5",
"lastUpdated": "2026-06-07T13:55:33.482Z",
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-05"
]
},
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/artifact-description",
"valueMarkdown": "Example of M11ReportSection05 Profile"
},
{
"url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
"valueCodeableConcept": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
"code": "active",
"display": "Active"
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]
}
}
],
"url": "https://fevir.net/resources/Composition/568047",
"identifier": [
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v2-0203",
"code": "ACSN",
"display": "Accession ID"
}
],
"text": "FEvIR Object Identifier"
},
"system": "https://fevir.net/FOI",
"value": "568047",
"assigner": {
"display": "Computable Publishing LLC"
}
}
],
"status": "final",
"type": {
"coding": [
{
"system": "http://loinc.org",
"code": "35528-9",
"display": "Clinical trial protocol Clinical trial protocol"
}
],
"text": "CeSHarP Report"
},
"category": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218547",
"display": "ICH M11 Protocol Section 5 TRIAL POPULATION"
}
],
"text": "section5-trial-population"
}
],
"subject": [
{
"reference": "ResearchStudy/568025",
"type": "ResearchStudy",
"display": "M11ResearchStudy Template"
}
],
"date": "2026-06-07T13:55:33.482Z",
"author": [
{
"display": "Brian S. Alper, MD, MSPH"
}
],
"title": "M11 Report Section 5 (Trial Population) for M11ResearchStudy Template",
"custodian": {
"reference": "Organization/118079",
"type": "Organization",
"display": "Computable Publishing LLC"
},
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"display": "Derived from"
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},
"targetReference": {
"reference": "ResearchStudy/568025",
"type": "ResearchStudy",
"display": "M11ResearchStudy Template"
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},
{
"type": {
"coding": [
{
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"code": "cite-as",
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},
"targetMarkdown": "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 2026-06-07. Available at: https://fevir.net/resources/Composition/568047. Computable resource at: https://fevir.net/resources/Composition/568047#json."
}
],
"section": [
{
"title": "5 TRIAL POPULATION",
"code": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218547",
"display": "ICH M11 Protocol Section 5 TRIAL POPULATION"
}
],
"text": "section5-trial-population"
},
"text": {
"status": "empty",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No text is intended here (heading only).]</div>"
},
"section": [
{
"title": "5.1 Description of Trial Population and Rationale",
"code": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218548",
"display": "ICH M11 Protocol Section 5.1 Description of Trial Population and Rationale"
}
],
"text": "section5.1-population-description"
},
"text": {
"status": "generated",
"div": "<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.\nInclusion Criteria:\n1. inclusion criterion 1\n2. inclusion criterion 2\nExclusion Criteria:\n1. exclusion criterion 1\n2. 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>"
},
"entry": [
{
"reference": "Group/568026",
"type": "Group",
"display": "StudyEligibilityCriteria for M11Report Example"
}
]
},
{
"title": "5.2 Inclusion Criteria",
"code": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218549",
"display": "ICH M11 Protocol Section 5.2 Inclusion Criteria"
}
],
"text": "section5.2-inclusion-criteria"
},
"text": {
"status": "generated",
"div": "<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>"
},
"entry": [
{
"reference": "Group/568026",
"type": "Group",
"display": "StudyEligibilityCriteria for M11Report Example"
}
]
},
{
"title": "5.3 Exclusion Criteria",
"code": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218550",
"display": "ICH M11 Protocol Section 5.3 Exclusion Criteria"
}
],
"text": "section5.3-exclusion-criteria"
},
"text": {
"status": "generated",
"div": "<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>"
},
"entry": [
{
"reference": "Group/568026",
"type": "Group",
"display": "StudyEligibilityCriteria for M11Report Example"
}
]
},
{
"title": "5.4 Contraception",
"code": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218551",
"display": "ICH M11 Protocol Section 5.4 Contraception"
}
],
"text": "section5.4-contraception"
},
"text": {
"status": "empty",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No text is intended here (heading only).]</div>"
},
"section": [
{
"title": "5.4.1 Definitions Related to Childbearing Potential",
"code": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218552",
"display": "ICH M11 Protocol Section 5.4.1 Definitions Related to Childbearing Potential"
}
],
"text": "section5.4.1-contraception-definitions"
},
"text": {
"status": "additional",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Specify the definitions of: • participant of childbearing potential, and • participant of nonchildbearing potential]</div>"
}
},
{
"title": "5.4.2 Contraception Requirements",
"code": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218553",
"display": "ICH M11 Protocol Section 5.4.2 Contraception Requirements"
}
],
"text": "section5.4.2-contraception-details"
},
"text": {
"status": "additional",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">[Specify the: • contraceptive methods required, and • duration of use]</div>"
}
}
]
},
{
"title": "5.5 Lifestyle Restrictions",
"code": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218554",
"display": "ICH M11 Protocol Section 5.5 Lifestyle Restrictions"
}
],
"text": "section5.5-lifestyle-restrictions"
},
"text": {
"status": "additional",
"div": "<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>"
},
"section": [
{
"title": "5.5.1 Meals and Dietary Restrictions",
"code": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218555",
"display": "ICH M11 Protocol Section 5.5.1 Meals and Dietary Restrictions"
}
],
"text": "section5.5.1-dietary-restrictions"
},
"text": {
"status": "additional",
"div": "<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>"
}
},
{
"title": "5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions",
"code": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218556",
"display": "ICH M11 Protocol Section 5.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions"
}
],
"text": "section5.5.2-substances-restrictions"
},
"text": {
"status": "additional",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">[If applicable, describe any restrictions on the intake of caffeine, alcohol, tobacco, or other restrictions.]</div>"
}
},
{
"title": "5.5.3 Physical Activity Restrictions",
"code": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218557",
"display": "ICH M11 Protocol Section 5.5.3 Physical Activity Restrictions"
}
],
"text": "section5.5.3-activity-restrictions"
},
"text": {
"status": "additional",
"div": "<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>"
}
},
{
"title": "5.5.4 Other Activity Restrictions",
"code": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218558",
"display": "ICH M11 Protocol Section 5.5.4 Other Activity Restrictions"
}
],
"text": "section5.5.4-other-restrictions"
},
"text": {
"status": "additional",
"div": "<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>"
}
}
]
},
{
"title": "5.6 Screen Failure and Rescreening",
"code": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C218559",
"display": "ICH M11 Protocol Section 5.6 Screen Failure and Rescreening"
}
],
"text": "section5.6-screen-failure"
},
"text": {
"status": "additional",
"div": "<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>"
}
}
]
}
]
}