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 568048</b></p><a name="568048"> </a><a name="hc568048"> </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-06.html">M11ReportSection06</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/568048">https://fevir.net/resources/Composition/568048</a></p><p><b>identifier</b>: FEvIR Object Identifier/568048</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 C218560}">section6-trial-intervention</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 6 (Trial Intervention) 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 6 (Trial Intervention) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568048. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568048. Computable resource at: https://fevir.net/resources/Composition/568048#json.</p>
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<title value="Trial Intervention and Concomitant Therapy"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[Trial interventions are all pre-specified investigational and noninvestigational medicinal products, medical devices or other interventions intended for the participants during the trial. The investigational trial intervention is the product used in the trial as part of trial objectives. Description of the investigational trial intervention is provided in Section 6.1 Description of Trial Intervention. Other trial interventions that are not part of trial objectives or do not have an investigational role in this trial are described in Section 6.9 Description of Noninvestigational Trial Interventions. Any regional requirements should be noted in the appropriate subsections. Provide an overview of investigational and noninvestigational trial interventions. Designate the trial intervention as IMP or NIMP/AxMP based on trial design and regional requirements. Consider an optional table with 12 columns (Arm Name, Arm Type, Intervention Name, Intervention Type, Pharmaceutical Dose Form, Dosage Strength(s), Dosage Level(s), Route of Administration, Regimen/Treatment Period/Vaccination Regimen, Use, IMP/NIMP, Sourcing).]</div>
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<title value="Description of Investigational Trial Intervention"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[Describe the investigational trial intervention to be administered in each arm of the trial and for each period of the trial including route and mode of administration, dose, dosage regimen, duration of intervention, use, packaging and labelling. Refer to approved regional labelling, as appropriate. For investigational drug/device combination products, include details on the configuration and use of the device and device manufacturer. A device user manual may be referenced in this section. Entries should Reference ExposureDefinition Profile of Group Resource.]</div>
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<section>
<title
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<div xmlns="http://www.w3.org/1999/xhtml">[Provide a rationale for the selection of the dose(s) or dose range, pharmaceutical dose form, route of administration, and dosing regimen of the investigational trial intervention, as applicable. This rationale should include relevant results from nonclinical studies and clinical trials that support selection of the dose and regimen. Discuss impact of differences in trial population characteristics (e.g., age, sex, race) which could lead to differences in pharmacokinetics and pharmacodynamics in this trial as compared to previous trials. If applicable, justify any differences in dose regimen or therapeutic use relative to approved labelling. Describe prior trials and other information that support the dose and/or dose regimen of the investigational trial intervention. Include a rationale for prospective dose adjustments incorporated in the trial, if any. Entries should Reference ExposureDefinition Profile of Group Resource.]</div>
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<title value="Investigational Trial Intervention Administration"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[Describe the detailed procedures for administration of each participant’s dose of each investigational trial intervention. This may include the timing of dosing (e.g., time of day, interval), the duration (e.g., the length of time participants will be administered the investigational trial intervention), and the timing of dosing relative to meals. Include any specific instructions on who, when or how to prepare and take the dose(s) and how to handle any delayed or missed doses. Dose escalation or cohort expansion as part of the overall design should be covered in Section 4.1 Description of Trial Design. Entries should Reference ActivityDefinition Resource.]</div>
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<section>
<title value="Investigational Trial Intervention Dose Modification"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[For each participant, describe any dose modifications allowed, including conditions for such dose modifications, particularly regarding failure to respond or safety concerns. State any minimum period required before a participant’s dose might be raised to the next higher dose or dose range. Include whether it is permissible to start and stop treatment and how dose reductions (if permitted) are to be managed. Information on stopping investigational trial intervention for participants due to safety/other reasons should be described in Section 7 Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial. Entries should Reference ActivityDefinition Resource.]</div>
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<title
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<div xmlns="http://www.w3.org/1999/xhtml">[Describe what is meant by investigational trial intervention overdose. Provide any available information on managing the overdose and ensure it is consistent with the Investigator’s Brochure or product labelling. Cross reference these documents as applicable. Entries should Reference ActivityDefinition Resource or PlanDefinition Resource.]</div>
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<title
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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="Preparation of Investigational Trial Intervention"/>
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<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Describe any preparation of the investigational trial intervention, and when necessary, who should prepare it. When applicable, describe the maximum hold time once thawed/mixed before administration. Include thawing, diluting, mixing, and reconstitution/preparation instructions. For drug/device combination products, include any relevant assembly or use instructions and reference the package insert that is provided separately. If the instructions are lengthy or complicated, it is acceptable to reference the package insert (if applicable) or include instructions in separate documents provided to the site (e.g., a pharmacy manual and reference the separate documents.]</div>
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<section>
<title
value="Storage and Handling of Investigational Trial Intervention"/>
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<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Describe storage and handling requirements (e.g., protection from light, temperature, humidity) for the investigational trial intervention(s). For trials in which multi-dose vials are utilised, provide additional information regarding stability and expiration time after initial use (e.g., if the seal is broken). Explain how the investigational trial intervention will be provided to the Investigator. If applicable, include details about kits, packaging, or other material of the investigational trial intervention for blinding purposes. If the instructions are lengthy or complicated, it is acceptable to reference the package insert (if applicable) or include instructions in separate documents provided to the site (e.g., a pharmacy manual) and reference the separate documents.]</div>
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<title value="Accountability of Investigational Trial Intervention"/>
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<text value="section6.6.3-accountability"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[Describe the accountability method, including: • how the investigational trial intervention will be distributed • who will distribute the investigational trial intervention • participation of a drug storage repository or pharmacy, if applicable • plans for disposal or return of unused product • if applicable, plans for reconciliation of investigational trial intervention]</div>
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<title
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<code value="C218570"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[No text is intended here (heading only).]</div>
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<section>
<title
value="Participant Assignment to Investigational Trial Intervention"/>
<code>
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<code value="C218571"/>
<display
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<text value="section6.7.1-assignment"/>
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<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[State that at enrollment, participant identification codes should be assigned. Describe the method of assigning participants to investigational trial intervention without being so specific that blinding or randomisation might be compromised. If assignment to investigational trial intervention is by randomisation, describe when randomisation occurs relative to screening. If adaptive randomisation or other methods of covariate balancing/minimisation are employed, include a cross reference to the methods of analysis in Section 10 Statistical Considerations. As applicable, details regarding the implementation of procedures to minimise bias should be described.]</div>
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<section>
<title value="Randomisation"/>
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<text value="section6.7.2-randomisation"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[Describe the randomisation procedures (e.g., central randomisation procedures), the method used to generate the randomisation schedule (e.g., computer generated), the source of the randomisation schedule (e.g., sponsor, investigator, or other), and whether IxRS will be used. To maintain the integrity of the blinding, do not include the block size.]</div>
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<section>
<title value="Measures to Maintain Blinding"/>
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<text value="section6.7.3-blinding"/>
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<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Describe measures that will be used to maintain blinding: • The investigational trial interventions are as indistinguishable as possible • Plans for the maintenance of randomisation codes and appropriate blinding for the trial • Procedures for planned (e.g., interim analysis) and unintentional (e.g., breach of procedure) breaking of randomisation codes. For unplanned but intentional actions (e.g., safety events), refer to Section 6.7.4 Emergency Unblinding at the Site. If the trial allows for some investigators or other designated staff to remain unblinded (e.g., to allow them to adjust investigational trial intervention), the means of maintaining the blinding for other investigators or staff should be explained. Measures to prevent unblinding by laboratory measurements or while performing study assessments, if used, should be described.]</div>
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<section>
<title value="Emergency Unblinding at the Site"/>
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<code value="C218574"/>
<display
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<text value="section6.7.4-unblinding"/>
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<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Describe the criteria for breaking the trial blind or participant code. Describe the circumstances that would require breaking the blind, either for an individual participant or all participants, and specify who will be responsible for this decision. Include the procedure for emergency unblinding as well as documentation of unblinding. Indicate to whom the intentional and unplanned unblinding should be reported.]</div>
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<section>
<title value="Investigational Trial Intervention Adherence"/>
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<text value="section6.8-intervention-adherence"/>
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<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Describe the measures to monitor and document participants’ adherence with investigational trial intervention (e.g., trial intervention accountability records, diary cards, or investigational trial intervention concentration measurements). List what documents are mandatory to complete (e.g., participant drug log) and what source data/records will be used to document investigational trial intervention adherence.]</div>
</text>
</section>
<section>
<title value="Description of Non-Investigational Trial Intervention"/>
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<display
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<text value="section6.9-noninvestigational-interventions"/>
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<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[As stated in Section 6 Trial Intervention and Concomitant Therapy, noninvestigational interventions are pre-specified products used in the trial but are not part of trial objectives and hence, are not investigational trial interventions.]</div>
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<section>
<title value="Background Trial Intervention"/>
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<text value="section6.9.1-background-intervention"/>
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<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Describe any background intervention(s), including administration and any conditions for use.]</div>
</text>
</section>
<section>
<title value="Rescue Therapy"/>
<code>
<coding>
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<code value="C218578"/>
<display value="ICH M11 Protocol Section 6.9.2 Rescue Therapy"/>
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<text value="section6.9.2-rescue-therapy"/>
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<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[List all permitted rescue medications, treatments, and/or procedures, including any relevant instructions on administration and any conditions of use. If administration of rescue therapy leads to the temporary discontinuation of trial intervention or a participant’s withdrawal from the trial, refer to Section 7 Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial.]</div>
</text>
</section>
<section>
<title value="Other Noninvestigational Trial Intervention"/>
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<code value="C218579"/>
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<text value="section6.9.3-other-therapy"/>
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<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[If applicable, describe the use of any other noninvestigational trial intervention, e.g., challenge agents or diagnostics.]</div>
</text>
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<section>
<title value="Concomitant Therapy"/>
<code>
<coding>
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<code value="C218580"/>
<display value="ICH M11 Protocol Section 6.10 Concomitant Therapy"/>
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<text value="section6.10-concomitant-therapy"/>
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<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[Specify the concomitant medications, supplements, complementary and alternative therapies, treatments, and/or procedures which are prohibited or permitted during the trial and include details about when the information will be collected (e.g., during screening, at each visit). When appropriate to separate the content, subheadings may be used.]</div>
</text>
<section>
<title value="Prohibited Concomitant Therapy"/>
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<coding>
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<code value="C218581"/>
<display
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<text value="section6.10.1-prohibited-concomitant-therapy"/>
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<div xmlns="http://www.w3.org/1999/xhtml">[If applicable, describe any prohibited concomitant therapy.]</div>
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<section>
<title value="Permitted Concomitant Therapy"/>
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<text value="section6.10.2-permitted-concomitant-therapy"/>
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<text>
<status value="empty"/>
<div xmlns="http://www.w3.org/1999/xhtml">[If applicable, describe any permitted concomitant therapy.]</div>
</text>
</section>
</section>
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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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