Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use

Single Institutional Review Board (sIRB) Implementation Guide, published by HL7 International - BR&R Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-sirb/ and changes regularly. See the Directory of published versions

## : sIRB Server Capability Statement - XML Representation

Draft as of 2022-10

Raw xml | Download

    <CapabilityStatement xmlns="http://hl7.org/fhir">
      <id value="sIRB-CapabilityStatementServer"/>
      <text>
        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml">
          <h2>sIRB Server Capability Statement</h2>
          <p>(Requirements Definition Capability Statement)</p>
          <p>Canonical URL: http://hl7.org/fhir/us/sirb/CapabilityStatement/sIRB-CapabilityStatementServer Version: 0.1.0 Published: 2022-10 (draft)</p>
          <p>Published by: <b>HL7 International - BR&amp;R Work Group</b></p>
          <p>This resource describes the required and desired behavior of FHIR servers 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 server behavior</h2>
          <p>Requirements for the sIRB FHIR Server that stores the Questionnaires and the QuestionnaireResponses. The FHIR Server is generally, but not always, hosted by the lead principal investigator's institution.</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>MAY</td>
                  <td>MAY</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>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 &amp; 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 &amp; 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 &amp; 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 &amp; 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>
      <url
           value="http://hl7.org/fhir/us/sirb/CapabilityStatement/sIRB-CapabilityStatementServer"/>
      <version value="1.0.0"/>
      <name value="CapabilityStatementServer_sIRB"/>
      <title value="sIRB Server Capability Statement"/>
      <status value="draft"/>
      <date value="2022-10"/>
      <publisher value="HL7 International - BR&amp;R Work Group"/>
      <contact>
        <name value="HL7 International - Biomedical Research and Regulation"/>
        <telecom>
          <system value="url"/>
          <value value="http://www.hl7.org/Special/committees/rcrim"/>
        </telecom>
      </contact>
      <description
                   value="This resource describes the required and desired behavior of FHIR servers for use and exchange of the single Institutional Review Board (sIRB) forms."/>
      <jurisdiction>
        <coding>
          <system value="urn:iso:std:iso:3166"/>
          <code value="US"/>
          <display value="United States of America"/>
        </coding>
        <text value="United States of America"/>
      </jurisdiction>
      <kind value="requirements"/>
      <fhirVersion value="4.0.1"/>
      <format value="xml"/>
      <format value="json"/>
      <patchFormat value="application/json-patch+json"/>
      <rest>
        <mode value="server"/>
        <documentation
                       value="Requirements for the sIRB FHIR Server that stores the Questionnaires and the QuestionnaireResponses. The FHIR Server is generally, but not always, hosted by the lead principal investigator's institution."/>
        <security>
          <description
                       value="Review the security recommendations on the FHIR Security page at http://hl7.org/fhir/R4/security.html"/>
        </security>
        <resource>
          <type value="Questionnaire"/>
          <interaction>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="SHOULD"/>
            </extension>
            <code value="search-type"/>
          </interaction>
          <interaction>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="SHALL"/>
            </extension>
            <code value="read"/>
          </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>
          <versioning value="versioned-update"/>
          <searchParam>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="SHALL"/>
            </extension>
            <name value="url"/>
            <definition
                        value="http://hl7.org/fhir/SearchParameter/Questionnaire-url"/>
            <type value="uri"/>
          </searchParam>
          <searchParam>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="SHOULD"/>
            </extension>
            <name value="version"/>
            <definition
                        value="http://hl7.org/fhir/SearchParameter/Questionnaire-version"/>
            <type value="token"/>
          </searchParam>
          <searchParam>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="SHOULD"/>
            </extension>
            <name value="status"/>
            <definition
                        value="http://hl7.org/fhir/SearchParameter/Questionnaire-status"/>
            <type value="token"/>
          </searchParam>
          <searchParam>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="SHOULD"/>
            </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"/>
            </extension>
            <name value="_id"/>
            <definition value="http://hl7.org/fhir/SearchParameter/Resource-id"/>
            <type value="token"/>
          </searchParam>
        </resource>
        <resource>
          <type value="QuestionnaireResponse"/>
          <interaction>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="SHOULD"/>
            </extension>
            <code value="search-type"/>
          </interaction>
          <interaction>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="SHALL"/>
            </extension>
            <code value="read"/>
          </interaction>
          <interaction>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="SHALL"/>
            </extension>
            <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"/>
            </extension>
            <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="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
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="MAY"/>
            </extension>
            <code value="read"/>
          </interaction>
          <interaction>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="MAY"/>
            </extension>
            <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
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="MAY"/>
            </extension>
            <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"/>
            </extension>
            <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"/>
            </extension>
            <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"/>
            </extension>
            <code value="search-type"/>
          </interaction>
          <interaction>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="MAY"/>
            </extension>
            <code value="read"/>
          </interaction>
          <interaction>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="MAY"/>
            </extension>
            <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>
          <versioning value="versioned-update"/>
          <searchParam>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/capabilitystatement-expectation">
              <valueCode value="MAY"/>
            </extension>
            <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>