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
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Composition 568051</b></p><a name="568051"> </a><a name="hc568051"> </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-09.html">M11ReportSection09</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/568051">https://fevir.net/resources/Composition/568051</a></p><p><b>identifier</b>: FEvIR Object Identifier/568051</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 C218608}">section9-adverse-events</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 9 (Adverse Events) 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 9 (Adverse Events) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568051. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568051. Computable resource at: https://fevir.net/resources/Composition/568051#json.</p>
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<div xmlns="http://www.w3.org/1999/xhtml">[No text is intended here (heading only).]</div>
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<title value="Definitions of Adverse Events"/>
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<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Specify the AE definitions, including: • any relevant regional AE requirements • any events that meet and do not meet the AE definition • any trial-specific AE clarifications • if applicable, any clarifications on the AE and SAE definitions for efficacy trials (e.g., lack of efficacy or failure of pharmacological actions reporting)]</div>
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<title value="Definitions of Serious Adverse Events"/>
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<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Specify the SAE definitions, including: • Any relevant regional SAE requirements. • Any events that meet and do not meet the SAE definition. • Any trial-specific SAE clarifications.]</div>
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<title value="Definitions of Product Complaints"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[Specify the definitions of product complaints in the context of the trial. If appropriate, include 9.1.3.1 Definition of Medical Device Product Complaints.]</div>
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<title value="Timing and Procedures for Collection and Reporting"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[Specify timing and procedures for collection and reporting of AEs, SAEs, product complaints (including medical device product complaints if applicable) and pregnancy and postpartum information in the sections below. This information may be summarized in a tabular format with 7 columns: Event Type, Situational Scope, Reportable Period Start, Reportable Period End, Timing for Reporting to Sponsor or Designee, Method for Reporting, Back-up Method for Reporting.]</div>
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<title value="Timing"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[Specify timing for collection and reporting, including: • start and end dates for collection and reporting • frequency of collection and reporting • cross reference to the Schedule of Assessments as appropriate]</div>
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<div xmlns="http://www.w3.org/1999/xhtml">[Specify procedures for collection and recording of AEs, SAEs, product complaints (including medical device product complaints if applicable) and pregnancy and postpartum information in the sections below.]</div>
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<title value="Identification"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[Specify how information will be identified (e.g., spontaneous reporting, solicited questions).]</div>
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<title value="Severity"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[Specify the intensity rating categories/scale.]</div>
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<title value="Causality"/>
<code>
<text value="section9.2.2.3-causality"/>
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<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Specify the causality categories/scale and the procedures for assessing causality.]</div>
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<title value="Recording"/>
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<text value="section9.2.2.4-recording"/>
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<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Specify procedures for recording.]</div>
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<title value="Follow-up"/>
<code>
<text value="section9.2.2.5-followup"/>
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<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Specify the procedures for follow-up. Include the assessment tools that will be used to monitor the events and the duration of follow-up after appearance of the events.]</div>
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<title value="Reporting"/>
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<text value="section9.2.3-reporting-events"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[Specify the reporting method (e.g., an electronic data collection tool or a paper CRF), backup reporting method if applicable and reporting timeline to the Sponsor]</div>
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<section>
<title value="Regulatory Reporting Requirements"/>
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<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Specify: • the Investigator’s responsibilities for reporting to the Sponsor (and to Ethics Committees, where required), specifying timing of reporting to allow the Sponsor to meet their responsibilities • the Sponsor’s legal/regulatory responsibilities to report to regulatory authorities, ethics committees, and investigators • serious and unexpected adverse reaction reporting]</div>
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<section>
<title value="Adverse Events of Special Interest"/>
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<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Specify any AESI: • any event (serious or nonserious) of scientific and medical concern relative to the trial intervention, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate • other events that merit reporting to the Sponsor, trial leadership, IRB, and regulatory agencies. Include the following for each AESI: • the definition • the approach for ascertaining information • if applicable, any approach to confirm or adjudicate the occurrence]</div>
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<section>
<title
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<div xmlns="http://www.w3.org/1999/xhtml">[Specify any DREs, DROs, or both that will not be reported as AEs or SAEs (e.g., seizures in anticonvulsant trials) or state “Not applicable.”]</div>
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<section>
<title value="Pregnancy and Postpartum Information"/>
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<text value="section9.3-pregnancy-postpartum"/>
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<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[No text is intended here (heading only).]</div>
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<title value="Participants Who Become Pregnant During the Trial"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[Specify: • the assessments to be performed • type and duration of monitoring • whether participants who become pregnant during the trial may continue with trial intervention or must be discontinued from trial intervention (refer to Section 7 Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial as applicable) • any trial modifications that need to be made for participants who become pregnant • what information will be collected about a participant who becomes pregnant during the trial (e.g., recording and reporting to the Sponsor, postpartum follow-up, trial intervention discontinuation or continuation, or trial withdrawal). For postpartum follow-up, include the time period (e.g., initial child development) with the justification. If exposure to trial intervention during breastfeeding is applicable, specify: • the assessments to be performed • type and duration of monitoring • what information will be collected for both the participant and child]</div>
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<section>
<title
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<text value="section9.3.2-pregnant-partner"/>
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<text>
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<div xmlns="http://www.w3.org/1999/xhtml">[Specify: • whether the investigator will attempt to collect pregnancy information about a participant’s partner who becomes pregnant during the specified period in the trial • whether the participant whose partner becomes pregnant should be discontinued from trial intervention (refer to Section 7 Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial as applicable) • the assessments to be performed, type and duration of monitoring, and the information to be collected]</div>
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<section>
<title value="Special Safety Situations"/>
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<display
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<text value="section9.4-special-safety-situations"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[Specify special safety situations associated with the trial intervention(s) that do not qualify as an AE or SAE, but require regulatory reporting. Examples include: • misuse or abuse • off-label use (if applicable) • medication error (prescription or dispensing error) • occupational exposure • use outside of what is foreseen in the protocol • unintended exposure of embryo, foetus, or child via maternal exposure (pregnancy or breastfeeding) or via paternal exposure (semen) • lack of therapeutic efficacy; this is not applicable for studies that measure efficacy as a study endpoint • suspected transmission of an infectious agent; this is only applicable for injected or biologic medicinal products • product complaint, including falsified or counterfeit products • suspected drug-food or drug-drug interaction]</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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