Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use
Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use
This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions 
| Draft as of 2022-10 |
<CapabilityStatement xmlns="http://hl7.org/fhir">
<id value="sIRB-CapabilityStatementClient"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<h2>sIRB Client Capability Statement</h2>
<p>(Requirements Definition Capability Statement)</p>
<p>Canonical URL: http://hl7.org/fhir/us/sirb/CapabilityStatement/sIRB-CapabilityStatementClient Version: 0.1.0 Published: 2022-10 (draft)</p>
<p>Published by: <b>HL7 International - BR&R Work Group</b></p>
<p>This resource describes the required and desired behavior of software clients for use and exchange of the single Institutional Review Board (sIRB) forms.</p>
<h2>General</h2>
<div class="table-wrapper">
<table class="grid">
<tbody>
<tr>
<th>FHIR Version:</th>
<td>4.0.1</td>
</tr>
<tr>
<th>Supported formats:</th>
<td>xml, json</td>
</tr>
</tbody>
</table>
</div>
<h2>REST client behavior</h2>
<p>Requirements for the REST FHIR Questionnaire Management Software (could be the research study system of the lead principal investigator's institution, another type of software or the sIRB on FHIR software).</p>
<p>
<b>Security:</b>
</p>
<p>Review the security recommendations on the FHIR Security page at http://hl7.org/fhir/R4/security.html</p>
<h3>Resource summary</h3>
<div class="table-wrapper">
<table class="grid">
<thead>
<tr>
<th>Resource</th>
<th>Search</th>
<th>Read</th>
<th>Read Version</th>
<th>Instance History</th>
<th>Resource History</th>
<th>Create</th>
<th>Update</th>
<th>Delete</th>
<th>Operations</th>
</tr>
</thead>
<tbody>
<tr>
<th>Questionnaire</th>
<td>SHOULD</td>
<td>SHALL</td>
<td/>
<td>MAY</td>
<td/>
<td/>
<td/>
<td/>
<td/>
</tr>
<tr>
<th>QuestionnaireResponse</th>
<td>SHOULD</td>
<td>SHALL</td>
<td>SHALL</td>
<td>MAY</td>
<td/>
<td>SHALL</td>
<td>SHALL</td>
<td/>
<td/>
</tr>
<tr>
<th>ResearchStudy</th>
<td>MAY</td>
<td>MAY</td>
<td>MAY</td>
<td>MAY</td>
<td/>
<td>MAY</td>
<td>MAY</td>
<td/>
<td/>
</tr>
<tr>
<th>Provenance</th>
<td>MAY</td>
<td>MAY</td>
<td>MAY</td>
<td>MAY</td>
<td/>
<td>MAY</td>
<td>MAY</td>
<td/>
<td/>
</tr>
</tbody>
</table>
</div>
<br/>
<br/>
<h3>
<a href="http://hl7.org/fhir/R4/questionnaire.html">Questionnaire</a>
</h3>
<h4>Interactions</h4>
<div class="table-wrapper">
<table class="list">
<thead>
<tr>
<th>Name</th>
<th>Conformance</th>
<th>Description</th>
</tr>
</thead>
<tbody/>
</table>
</div>
<h4>Search</h4>
<div class="table-wrapper">
<table class="list">
<thead>
<tr>
<th>Parameter</th>
<th>Conformance</th>
<th>Type</th>
<th>Definition & Chaining</th>
</tr>
</thead>
<tbody>
<tr>
<th>url</th>
<td>SHALL</td>
<td>uri</td>
<td/>
</tr>
<tr>
<th>version</th>
<td>SHOULD</td>
<td>token</td>
<td/>
</tr>
<tr>
<th>status</th>
<td>SHOULD</td>
<td>token</td>
<td/>
</tr>
<tr>
<th>_lastUpdated</th>
<td>SHOULD</td>
<td>date</td>
<td/>
</tr>
<tr>
<th>_id</th>
<td>MAY</td>
<td>token</td>
<td/>
</tr>
</tbody>
</table>
</div>
<br/>
<br/>
<h3>
<a href="http://hl7.org/fhir/R4/questionnaireresponse.html">QuestionnaireResponse</a>
</h3>
<h4>Behavior</h4>
<p>Versioning support: versioned-update</p>
<h4>Interactions</h4>
<div class="table-wrapper">
<table class="list">
<thead>
<tr>
<th>Name</th>
<th>Conformance</th>
<th>Description</th>
</tr>
</thead>
<tbody/>
</table>
</div>
<h4>Search</h4>
<p>Supported Includes: QuestionnaireResponse.questionnaire</p>
<div class="table-wrapper">
<table class="list">
<thead>
<tr>
<th>Parameter</th>
<th>Conformance</th>
<th>Type</th>
<th>Definition & Chaining</th>
</tr>
</thead>
<tbody>
<tr>
<th>questionnaire</th>
<td>SHALL</td>
<td>reference</td>
<td/>
</tr>
<tr>
<th>author</th>
<td>SHALL</td>
<td>reference</td>
<td/>
</tr>
<tr>
<th>_lastUpdated</th>
<td>SHALL</td>
<td>date</td>
<td/>
</tr>
<tr>
<th>_id</th>
<td>MAY</td>
<td>token</td>
<td/>
</tr>
<tr>
<th>identifier</th>
<td>SHOULD</td>
<td>token</td>
<td/>
</tr>
<tr>
<th>status</th>
<td>SHALL</td>
<td>token</td>
<td/>
</tr>
</tbody>
</table>
</div>
<br/>
<br/>
<h3>
<a href="http://hl7.org/fhir/R4/researchstudy.html">ResearchStudy</a>
</h3>
<h4>Behavior</h4>
<p>Versioning support: versioned-update</p>
<h4>Interactions</h4>
<div class="table-wrapper">
<table class="list">
<thead>
<tr>
<th>Name</th>
<th>Conformance</th>
<th>Description</th>
</tr>
</thead>
<tbody/>
</table>
</div>
<h4>Search</h4>
<div class="table-wrapper">
<table class="list">
<thead>
<tr>
<th>Parameter</th>
<th>Conformance</th>
<th>Type</th>
<th>Definition & Chaining</th>
</tr>
</thead>
<tbody>
<tr>
<th>identifier</th>
<td>MAY</td>
<td>token</td>
<td/>
</tr>
<tr>
<th>_id</th>
<td>MAY</td>
<td>token</td>
<td/>
</tr>
<tr>
<th>title</th>
<td>MAY</td>
<td>string</td>
<td/>
</tr>
<tr>
<th>keyword</th>
<td>MAY</td>
<td>token</td>
<td/>
</tr>
</tbody>
</table>
</div>
<br/>
<br/>
<h3>
<a href="http://hl7.org/fhir/R4/provenance.html">Provenance</a>
</h3>
<h4>Behavior</h4>
<p>Versioning support: versioned-update</p>
<h4>Interactions</h4>
<div class="table-wrapper">
<table class="list">
<thead>
<tr>
<th>Name</th>
<th>Conformance</th>
<th>Description</th>
</tr>
</thead>
<tbody/>
</table>
</div>
<h4>Search</h4>
<div class="table-wrapper">
<table class="list">
<thead>
<tr>
<th>Parameter</th>
<th>Conformance</th>
<th>Type</th>
<th>Definition & Chaining</th>
</tr>
</thead>
<tbody>
<tr>
<th>_id</th>
<td>MAY</td>
<td>token</td>
<td/>
</tr>
<tr>
<th>target</th>
<td>SHOULD</td>
<td>reference</td>
<td/>
</tr>
<tr>
<th>when</th>
<td>SHOULD</td>
<td>date</td>
<td/>
</tr>
</tbody>
</table>
</div>
</div>
</text>
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<version value="1.0.0"/>
<name value="CapabilityStatementClient_sIRB"/>
<title value="sIRB Client Capability Statement"/>
<status value="draft"/>
<date value="2022-10"/>
<publisher value="HL7 International - BR&R Work Group"/>
<contact>
<name value="HL7 International - Biomedical Research and Regulation"/>
<telecom>
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<jurisdiction>
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<display value="United States of America"/>
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<text value="United States of America"/>
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<kind value="requirements"/>
<fhirVersion value="4.0.1"/>
<format value="xml"/>
<format value="json"/>
<patchFormat value="application/json-patch+json"/>
<rest>
<mode value="client"/>
<documentation
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<security>
<description
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</security>
<resource>
<type value="Questionnaire"/>
<interaction>
<extension
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<valueCode value="SHOULD"/>
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<code value="search-type"/>
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<searchParam>
<extension
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<valueCode value="SHOULD"/>
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<definition
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<type value="token"/>
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<valueCode value="SHOULD"/>
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<valueCode value="SHOULD"/>
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<name value="_lastUpdated"/>
<definition
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<type value="date"/>
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<searchParam>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
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<name value="_id"/>
<definition value="http://hl7.org/fhir/SearchParameter/Resource-id"/>
<type value="token"/>
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<type value="QuestionnaireResponse"/>
<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="SHOULD"/>
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<interaction>
<extension
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<valueCode value="SHALL"/>
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<code value="vread"/>
</interaction>
<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
</extension>
<code value="history-instance"/>
</interaction>
<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="SHALL"/>
</extension>
<code value="create"/>
</interaction>
<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="SHALL"/>
</extension>
<code value="update"/>
</interaction>
<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
</extension>
<code value="patch"/>
</interaction>
<versioning value="versioned-update"/>
<readHistory value="true"/>
<searchInclude value="QuestionnaireResponse.questionnaire"/>
<searchParam>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="SHALL"/>
</extension>
<name value="questionnaire"/>
<definition
value="http://hl7.org/fhir/SearchParameter/QuestionnaireResponse-questionnaire"/>
<type value="reference"/>
</searchParam>
<searchParam>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="SHALL"/>
</extension>
<name value="author"/>
<definition
value="http://hl7.org/fhir/SearchParameter/QuestionnaireResponse-author"/>
<type value="reference"/>
</searchParam>
<searchParam>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="SHALL"/>
</extension>
<name value="_lastUpdated"/>
<definition
value="http://hl7.org/fhir/SearchParameter/Resource-lastUpdated"/>
<type value="date"/>
</searchParam>
<searchParam>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
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<name value="_id"/>
<definition value="http://hl7.org/fhir/SearchParameter/Resource-id"/>
<type value="token"/>
</searchParam>
<searchParam>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="SHOULD"/>
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<name value="identifier"/>
<definition
value="http://hl7.org/fhir/SearchParameter/QuestionnaireResponse-identifier"/>
<type value="token"/>
</searchParam>
<searchParam>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="SHALL"/>
</extension>
<name value="status"/>
<definition
value="http://hl7.org/fhir/SearchParameter/QuestionnaireResponse-status"/>
<type value="token"/>
</searchParam>
</resource>
<resource>
<type value="ResearchStudy"/>
<documentation
value="If an implementer wishes to optionally use the ResearchStudy resource to transmit or persist data, the R4 base definition of the ResearchStudy resource MAY be used."/>
<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
</extension>
<code value="search-type"/>
</interaction>
<interaction>
<extension
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<valueCode value="MAY"/>
</extension>
<code value="read"/>
</interaction>
<interaction>
<extension
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<valueCode value="MAY"/>
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<code value="vread"/>
</interaction>
<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
</extension>
<code value="history-instance"/>
</interaction>
<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
</extension>
<code value="create"/>
</interaction>
<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
</extension>
<code value="update"/>
</interaction>
<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
</extension>
<code value="patch"/>
</interaction>
<versioning value="versioned-update"/>
<searchParam>
<extension
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<valueCode value="MAY"/>
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<name value="identifier"/>
<definition
value="http://hl7.org/fhir/SearchParameter/ResearchStudy-identifier"/>
<type value="token"/>
</searchParam>
<searchParam>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
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<name value="_id"/>
<definition value="http://hl7.org/fhir/SearchParameter/Resource-id"/>
<type value="token"/>
</searchParam>
<searchParam>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
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<name value="title"/>
<definition
value="http://hl7.org/fhir/SearchParameter/ResearchStudy-title"/>
<type value="string"/>
</searchParam>
<searchParam>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
</extension>
<name value="keyword"/>
<definition
value="http://hl7.org/fhir/SearchParameter/ResearchStudy-keyword"/>
<type value="token"/>
</searchParam>
</resource>
<resource>
<type value="Provenance"/>
<documentation
value="If an implementer wishes to capture information about data creation, update, modification or deletion activities, the Provenance resource MAY be utilized. The Provenance resource can assist with data authenticity and assessing the entities involved with data being stored or transmitted via the system."/>
<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
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<code value="search-type"/>
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<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
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<code value="read"/>
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<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
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<code value="vread"/>
</interaction>
<interaction>
<extension
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<valueCode value="MAY"/>
</extension>
<code value="history-instance"/>
</interaction>
<interaction>
<extension
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<valueCode value="MAY"/>
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<code value="create"/>
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<interaction>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
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<code value="update"/>
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<versioning value="versioned-update"/>
<searchParam>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="MAY"/>
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<name value="_id"/>
<definition value="http://hl7.org/fhir/SearchParameter/Resource-id"/>
<type value="token"/>
</searchParam>
<searchParam>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="SHOULD"/>
</extension>
<name value="target"/>
<definition
value="http://hl7.org/fhir/SearchParameter/Provenance-target"/>
<type value="reference"/>
</searchParam>
<searchParam>
<extension
url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
<valueCode value="SHOULD"/>
</extension>
<name value="when"/>
<definition
value="http://hl7.org/fhir/SearchParameter/Provenance-when"/>
<type value="date"/>
</searchParam>
</resource>
</rest>
</CapabilityStatement>
IG © 2020+ HL7 International - BR&R Work Group. Package hl7.fhir.us.sirb#1.0.0 based on FHIR 4.0.1. Generated 2023-04-20
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