Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
<Composition xmlns="http://hl7.org/fhir">
<id value="568057"/>
<meta>
<versionId value="2"/>
<lastUpdated value="2026-05-30T15:48:01.025Z"/>
<profile
value="http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-container"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Composition 568057</b></p><a name="568057"> </a><a name="hc568057"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 2; Last updated: 2026-05-30 15:48:01+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-m11-report-container.html">M11ReportContainer</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}">Active</span></p><p><b>url</b>: <a href="https://fevir.net/resources/Composition/568057">https://fevir.net/resources/Composition/568057</a></p><p><b>identifier</b>: FEvIR Object Identifier/568057</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{http://loinc.org 35528-9}">CeSHarP Report</span></p><p><b>date</b>: 2026-05-30 15:48:01+0000</p><p><b>author</b>: Brian S. Alper, MD, MSPH</p><p><b>title</b>: M11 Report for M11ResearchStudy Template</p><p><b>custodian</b>: <a href="Organization-118079.html">Computable Publishing LLC</a></p><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Derived From</p><p><b>target</b>: <a href="ResearchStudy-568025.html">M11ResearchStudy Template</a></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Cite As</p><p><b>target</b>: </p><div><p>M11 Report for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568057. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568057. Computable resource at: https://fevir.net/resources/Composition/568057#json.</p>
</div></blockquote></div>
</text>
<extension
url="http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status">
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/cited-artifact-status-type"/>
<code value="active"/>
<display value="Active"/>
</coding>
</valueCodeableConcept>
</extension>
<url value="https://fevir.net/resources/Composition/568057"/>
<identifier>
<type>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
<code value="ACSN"/>
<display value="Accession ID"/>
</coding>
<text value="FEvIR Object Identifier"/>
</type>
<system value="https://fevir.net/FOI"/>
<value value="568057"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="http://loinc.org"/>
<code value="35528-9"/>
<display value="Clinical trial protocol Clinical trial protocol"/>
</coding>
<text value="CeSHarP Report"/>
</type>
<subject>🔗
<reference value="ResearchStudy/568025"/>
<type value="ResearchStudy"/>
<display value="M11ResearchStudy Template"/>
</subject>
<date value="2026-05-30T15:48:01.025Z"/>
<author>
<display value="Brian S. Alper, MD, MSPH"/>
</author>
<title value="M11 Report for M11ResearchStudy Template"/>
<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 for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568057. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568057. Computable resource at: https://fevir.net/resources/Composition/568057#json."/>
</relatesTo>
<section>
<title value="Title Page"/>
<code>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C222769"/>
<display value="ICH M11 Protocol Section Title Page"/>
</coding>
<text value="section0-title-page"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><table><tbody><tr><td>Full Title:</td><td>M11ResearchStudy Template</td></tr><tr><td>Sponsor Protocol Identifier:</td><td>[Replace with a unique alphanumeric identifier for the trial, designated by the sponsor.]</td></tr><tr><td>Original Protocol:</td><td>[Original Protocol Indicator]</td></tr><tr><td>Version Number:</td><td>[For use by the sponsor at their discretion.]</td></tr><tr><td>Version Date:</td><td>[For use by the sponsor at their discretion.]</td></tr><tr><td>Sponsor’s Investigational Product Code(s):</td><td>[Enter the sponsor’s unique identifier for investigational product(s) in the trial.Add fields as needed.]</td></tr><tr><td>Investigational Product Name(s):</td><td>[Omit nonproprietary name field if a nonproprietary name has not yet been assigned. Omit proprietary name field if not yet established.]</td></tr><tr><td>Trial Phase:</td><td>[For trials combining investigational drugs or vaccines with devices, classify according to the phase of drug development.]</td></tr><tr><td>Sponsor Name and Address:</td><td><p>[Enter Sponsor Name.]</p><p>[Enter Sponsor Legal Address.]</p><p>[Add headings and lines for each Co-Sponsor Name and Address: and Local Sponsor Name and Address: if needed.]</p></td></tr><tr><td>Device Manufacturer Name and Address:</td><td>[Manufacturer name and address information is required only for drug / device combination protocols that include investigational device(s) and should not be included for other protocols.Include the manufacturer address only if the manufacturer is different than the sponsor listed above. Add additional fields as needed if multiple investigational devices will be used in the trial or if there are multiple manufacturers for a single device. Delete this line if not applicable.]</td></tr><tr><td>Regulatory or Clinical Trial Identifier(s):</td><td><p>FOI 568025</p><p>identifier [To be replaced] assigned by [To be replaced]</p></td></tr><tr><td>Sponsor Approval:</td><td>[Enter Sponsor Approval Date or State location where sponsor approval information can be found]</td></tr></tbody></table><p>Sponsor Signatory: [Enter sponsor signatory (e.g., name, title, signature and date, or tate location where sponsor signatory information can be found (e.g., electronic signature)]</p><p>Medical Expert Contact: [Enter Medical Expert contact information(as designated by sponsor, or State location where Medical Expert contact information can be found]</p><p>Amendment Details [For an original protocol that has not been amended, state { This protocol has not been amended.} Otherwise state { This is the first protocol amendment.} Or { This protocol has been amended previously. Details of prior amendments are presented in Section 12.3 Prior Protocol Amendment(s).}]</p></div>
</text>
</section>
<section>
<title value="Sections 1-14"/>
<code>
<text value="sections"/>
</code>
<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Entries should Reference Composition Resource (M11ReportSection01 through M11ReportSection14 Profiles).]</div>
</text>
<entry>🔗
<reference value="Composition/568043"/>
<type value="Composition"/>
<display
value="M11 Report Section 1 (Protocol Summary) for M11ResearchStudy Template"/>
</entry>
<entry>🔗
<reference value="Composition/568044"/>
<type value="Composition"/>
<display
value="M11 Report Section 2 (Introduction) for M11ResearchStudy Template"/>
</entry>
<entry>🔗
<reference value="Composition/568045"/>
<type value="Composition"/>
<display
value="M11 Report Section 3 (Trial Objectives and Associated Estimands) for M11ResearchStudy Template"/>
</entry>
<entry>🔗
<reference value="Composition/568046"/>
<type value="Composition"/>
<display
value="M11 Report Section 4 (Trial Design) for M11ResearchStudy Template"/>
</entry>
<entry>🔗
<reference value="Composition/568047"/>
<type value="Composition"/>
<display
value="M11 Report Section 5 (Trial Population) for M11ResearchStudy Template"/>
</entry>
<entry>🔗
<reference value="Composition/568048"/>
<type value="Composition"/>
<display
value="M11 Report Section 6 (Trial Intervention) for M11ResearchStudy Template"/>
</entry>
<entry>🔗
<reference value="Composition/568049"/>
<type value="Composition"/>
<display
value="M11 Report Section 7 (Participant Discontinuation) for M11ResearchStudy Template"/>
</entry>
<entry>🔗
<reference value="Composition/568050"/>
<type value="Composition"/>
<display
value="M11 Report Section 8 (Trial Assessments) for M11ResearchStudy Template"/>
</entry>
<entry>🔗
<reference value="Composition/568051"/>
<type value="Composition"/>
<display
value="M11 Report Section 9 (Adverse Events) for M11ResearchStudy Template"/>
</entry>
<entry>🔗
<reference value="Composition/568052"/>
<type value="Composition"/>
<display
value="M11 Report Section 10 (Statistical Considerations) for M11ResearchStudy Template"/>
</entry>
<entry>🔗
<reference value="Composition/568053"/>
<type value="Composition"/>
<display
value="M11 Report Section 11 (Trial Oversight) for M11ResearchStudy Template"/>
</entry>
<entry>🔗
<reference value="Composition/568054"/>
<type value="Composition"/>
<display
value="M11 Report Section 12 (Supporting Details) for M11ResearchStudy Template"/>
</entry>
<entry>🔗
<reference value="Composition/568055"/>
<type value="Composition"/>
<display
value="M11 Report Section 13 (Glossary) for M11ResearchStudy Template"/>
</entry>
<entry>🔗
<reference value="Composition/568056"/>
<type value="Composition"/>
<display
value="M11 Report Section 14 (References) for M11ResearchStudy Template"/>
</entry>
</section>
</Composition>
IG © 2024+ HL7 International / Clinical Decision Support.
Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot3.
Generated
2026-06-02
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change