Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - 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-ballot2 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: Trial-use | Maturity Level: 1 |
<CodeSystem xmlns="http://hl7.org/fhir">
<id value="research-study-document-types-code-system"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem research-study-document-types-code-system</b></p><a name="research-study-document-types-code-system"> </a><a name="hcresearch-study-document-types-code-system"> </a><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/ebm/CodeSystem/research-study-document-types-code-system</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style="white-space:nowrap">adverse-event-monitoring-plan<a name="research-study-document-types-code-system-adverse-event-monitoring-plan"> </a></td><td>Adverse event monitoring plan</td><td>The detailed protocol for how unintended and undesired experiences and consequences related to a study will be identified, reported, and managed.</td></tr><tr><td style="white-space:nowrap">ancillary-care-plan<a name="research-study-document-types-code-system-ancillary-care-plan"> </a></td><td>Ancillary care plan</td><td>The detailed protocol for treatment and supportive care activities provided during and after the study.</td></tr><tr><td style="white-space:nowrap">auditing-plan<a name="research-study-document-types-code-system-auditing-plan"> </a></td><td>Auditing plan</td><td>The detailed protocol for how research study integrity will be evaluated, monitored, and managed.</td></tr><tr><td style="white-space:nowrap">confidential-personal-data-management-plan<a name="research-study-document-types-code-system-confidential-personal-data-management-plan"> </a></td><td>Confidential personal data management plan</td><td>The detailed protocol for how personally identifiable data from a research study will be shared and preserved, and how such data will be protected from inappropriate sharing.</td></tr><tr><td style="white-space:nowrap">consent-form<a name="research-study-document-types-code-system-consent-form"> </a></td><td>Consent form</td><td>The document used to obtain and record consent or assent.</td></tr><tr><td style="white-space:nowrap">consent-plan<a name="research-study-document-types-code-system-consent-plan"> </a></td><td>Consent plan</td><td>The detailed protocol for how consent or assent will be obtained.</td></tr><tr><td style="white-space:nowrap">data-access-plan<a name="research-study-document-types-code-system-data-access-plan"> </a></td><td>Data access plan</td><td>The detailed protocol for how all of some of the research study dataset will be made available.</td></tr><tr><td style="white-space:nowrap">data-management-plan<a name="research-study-document-types-code-system-data-management-plan"> </a></td><td>Data management plan</td><td>The detailed protocol for how data from a study will be collected, preserved, and shared.</td></tr><tr><td style="white-space:nowrap">dataset<a name="research-study-document-types-code-system-dataset"> </a></td><td>Dataset</td><td>The collection of data generated by the research study.</td></tr><tr><td style="white-space:nowrap">dataset-access<a name="research-study-document-types-code-system-dataset-access"> </a></td><td>Dataset access</td><td>The information related to how to access the dataset.</td></tr><tr><td style="white-space:nowrap">declaration-of-interests<a name="research-study-document-types-code-system-declaration-of-interests"> </a></td><td>Declaration of interests</td><td>The statement of conflicts of interest for investigators or anyone involved in decisions regardign study methods and reporting.</td></tr><tr><td style="white-space:nowrap">dissemination-plan<a name="research-study-document-types-code-system-dissemination-plan"> </a></td><td>Dissemination plan</td><td>The detailed protocol for how research study results will be reported and advertised.</td></tr><tr><td style="white-space:nowrap">education<a name="research-study-document-types-code-system-education"> </a></td><td>Education</td><td>Instructional and orientational information.</td></tr><tr><td style="white-space:nowrap">interim-analysis-plan<a name="research-study-document-types-code-system-interim-analysis-plan"> </a></td><td>Interim analysis plan</td><td>The detailed protocol for how data from a study will be analyzed and reported before the completion of study data collection.</td></tr><tr><td style="white-space:nowrap">irb-approval<a name="research-study-document-types-code-system-irb-approval"> </a></td><td>Institutional Review Board (IRB) approval</td><td>The document that proposed or establishes Institutional Review Board (IRB) approval.</td></tr><tr><td style="white-space:nowrap">software<a name="research-study-document-types-code-system-software"> </a></td><td>Software</td><td>The executable tools used to support the conduct and reporting of the research study.</td></tr><tr><td style="white-space:nowrap">software-access<a name="research-study-document-types-code-system-software-access"> </a></td><td>Software access</td><td>The information related to how to access the research software.</td></tr><tr><td style="white-space:nowrap">specimen-plan<a name="research-study-document-types-code-system-specimen-plan"> </a></td><td>Specimen plan</td><td>The detailed protocol for how specimens collected during the study will be managed.</td></tr><tr><td style="white-space:nowrap">statistical-analysis-plan<a name="research-study-document-types-code-system-statistical-analysis-plan"> </a></td><td>Statistical analysis plan</td><td>The detailed protocol for stastical methods and reporting procedures for analyzing the data collected from a study.</td></tr></table></div>
</text>
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<name value="ResearchStudyDocumentTypesCodeSystem"/>
<title value="Research Study Document Types Code System"/>
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<experimental value="false"/>
<date value="2025-09-10T16:45:37+00:00"/>
<publisher value="HL7 International / Clinical Decision Support"/>
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<concept>
<code value="adverse-event-monitoring-plan"/>
<display value="Adverse event monitoring plan"/>
<definition
value="The detailed protocol for how unintended and undesired experiences and consequences related to a study will be identified, reported, and managed."/>
</concept>
<concept>
<code value="ancillary-care-plan"/>
<display value="Ancillary care plan"/>
<definition
value="The detailed protocol for treatment and supportive care activities provided during and after the study."/>
</concept>
<concept>
<code value="auditing-plan"/>
<display value="Auditing plan"/>
<definition
value="The detailed protocol for how research study integrity will be evaluated, monitored, and managed."/>
</concept>
<concept>
<code value="confidential-personal-data-management-plan"/>
<display value="Confidential personal data management plan"/>
<definition
value="The detailed protocol for how personally identifiable data from a research study will be shared and preserved, and how such data will be protected from inappropriate sharing."/>
</concept>
<concept>
<code value="consent-form"/>
<display value="Consent form"/>
<definition
value="The document used to obtain and record consent or assent."/>
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<concept>
<code value="consent-plan"/>
<display value="Consent plan"/>
<definition
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<display value="Data access plan"/>
<definition
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</concept>
<concept>
<code value="data-management-plan"/>
<display value="Data management plan"/>
<definition
value="The detailed protocol for how data from a study will be collected, preserved, and shared."/>
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<concept>
<code value="dataset"/>
<display value="Dataset"/>
<definition
value="The collection of data generated by the research study."/>
</concept>
<concept>
<code value="dataset-access"/>
<display value="Dataset access"/>
<definition
value="The information related to how to access the dataset."/>
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<concept>
<code value="declaration-of-interests"/>
<display value="Declaration of interests"/>
<definition
value="The statement of conflicts of interest for investigators or anyone involved in decisions regardign study methods and reporting."/>
</concept>
<concept>
<code value="dissemination-plan"/>
<display value="Dissemination plan"/>
<definition
value="The detailed protocol for how research study results will be reported and advertised."/>
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<concept>
<code value="education"/>
<display value="Education"/>
<definition value="Instructional and orientational information."/>
</concept>
<concept>
<code value="interim-analysis-plan"/>
<display value="Interim analysis plan"/>
<definition
value="The detailed protocol for how data from a study will be analyzed and reported before the completion of study data collection."/>
</concept>
<concept>
<code value="irb-approval"/>
<display value="Institutional Review Board (IRB) approval"/>
<definition
value="The document that proposed or establishes Institutional Review Board (IRB) approval."/>
</concept>
<concept>
<code value="software"/>
<display value="Software"/>
<definition
value="The executable tools used to support the conduct and reporting of the research study."/>
</concept>
<concept>
<code value="software-access"/>
<display value="Software access"/>
<definition
value="The information related to how to access the research software."/>
</concept>
<concept>
<code value="specimen-plan"/>
<display value="Specimen plan"/>
<definition
value="The detailed protocol for how specimens collected during the study will be managed."/>
</concept>
<concept>
<code value="statistical-analysis-plan"/>
<display value="Statistical analysis plan"/>
<definition
value="The detailed protocol for stastical methods and reporting procedures for analyzing the data collected from a study."/>
</concept>
</CodeSystem>
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot2 based on FHIR 6.0.0-ballot3. Generated 2025-09-10
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