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 |
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Composition 568049</b></p><a name="568049"> </a><a name="hc568049"> </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: 1; Last updated: 2026-05-30 15:21:18+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-m11-report-section-07.html">M11ReportSection07</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/568049">https://fevir.net/resources/Composition/568049</a></p><p><b>identifier</b>: FEvIR Object Identifier/568049</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>category</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218583}">section7-participant-discontinuation</span></p><p><b>date</b>: 2026-05-30 15:21:18+0000</p><p><b>author</b>: Brian S. Alper, MD, MSPH</p><p><b>title</b>: M11 Report Section 7 (Participant Discontinuation) 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 Section 7 (Participant Discontinuation) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568049. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568049. Computable resource at: https://fevir.net/resources/Composition/568049#json.</p>
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<div xmlns="http://www.w3.org/1999/xhtml">[Describe: • the criteria for discontinuation of a participant from any trial intervention, carefully evaluating which are appropriate for the trial population and therapy being studied • how participants who discontinue trial intervention will be followed after discontinuation. Depending on the chosen intercurrent event handling strategy, it will be important to continue to follow and ascertain outcomes in participants who discontinue treatment through the end of the trial to prevent missing data in important analyses. Refer to Section 1.3 Schedule of Activities for assessments to be performed at the time of and following discontinuation of trial intervention • the process for collecting and recording the detailed reasons for discontinuing trial intervention if not described elsewhere]</div>
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<div xmlns="http://www.w3.org/1999/xhtml">[Describe: • the criteria for temporary discontinuation or interruption of trial intervention for an individual participant • what to do and which restrictions still apply if the participant has to temporarily discontinue or interrupt trial intervention • whether the participant will continue in the trial • which assessments will be performed for the stated duration of the trial. Details of any rechallenge or restart after a safety-related event should be included in Section 7.1.3 Rechallenge.]</div>
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<div xmlns="http://www.w3.org/1999/xhtml">[Describe the criteria for participant discontinuation or withdrawal from the trial. Describe the reason for withdrawal and the type of data to be collected for the final assessments with reference to the schedule of activities for the participant’s end of study visit unless provided in another section. In many cases, the only reason for a participant being considered withdrawn from the trial should be a participant’s withdrawal of consent to continue to participate in the trial. All other participants, including those who discontinue treatment, should remain in the trial and continue to be followed to prevent missing data in important analyses. Refer to Section 10 Statistical Considerations for the data that must be collected for the trial estimands.]</div>
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<div xmlns="http://www.w3.org/1999/xhtml">[Describe how the trial will define how participants are lost to follow-up. In general, participants should be considered lost to follow-up only if they cannot be reached despite multiple attempts to contact. Also describe approaches that will be used to minimise loss to follow-up, such as multiple, diverse methods to remain in contact with participants (e.g., telephone calls, texts, and emails to the participant) and how contacts will be recorded.]</div>
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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
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