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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
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Definition for Code System ResearchStudyStatus
<?xml version="1.0" encoding="UTF-8"?> <CodeSystem xmlns="http://hl7.org/fhir"> <id value="research-study-status"/> <meta> <lastUpdated value="2019-12-31T21:03:40.621+11:00"/> </meta> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"> <h2> ResearchStudyStatus</h2> <div> <p> Codes that convey the current status of the research study.</p> </div> <p> This code system http://hl7.org/fhir/research-study-status 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">active <a name="research-study-status-active"> </a> </td> <td> Active</td> <td> Study is opened for accrual.</td> </tr> <tr> <td style="white-space:nowrap">administratively-completed <a name="research-study-status-administratively-completed"> </a> </td> <td> Administratively Completed</td> <td> Study is completed prematurely and will not resume; patients are no longer examined nor treated.</td> </tr> <tr> <td style="white-space:nowrap">approved <a name="research-study-status-approved"> </a> </td> <td> Approved</td> <td> Protocol is approved by the review board.</td> </tr> <tr> <td style="white-space:nowrap">closed-to-accrual <a name="research-study-status-closed-to-accrual"> </a> </td> <td> Closed to Accrual</td> <td> Study is closed for accrual; patients can be examined and treated.</td> </tr> <tr> <td style="white-space:nowrap">closed-to-accrual-and-intervention <a name="research-study-status-closed-to-accrual-and-intervention"> </a> </td> <td> Closed to Accrual and Intervention</td> <td> Study is closed to accrual and intervention, i.e. the study is closed to enrollment, all study subjects have completed treatment or intervention but are still being followed according to the primary objective of the study.</td> </tr> <tr> <td style="white-space:nowrap">completed <a name="research-study-status-completed"> </a> </td> <td> Completed</td> <td> Study is closed to accrual and intervention, i.e. the study is closed to enrollment, all study subjects have completed treatment or intervention but are still being followed according to the primary objective of the study.</td> </tr> <tr> <td style="white-space:nowrap">disapproved <a name="research-study-status-disapproved"> </a> </td> <td> Disapproved</td> <td> Protocol was disapproved by the review board.</td> </tr> <tr> <td style="white-space:nowrap">in-review <a name="research-study-status-in-review"> </a> </td> <td> In Review</td> <td> Protocol is submitted to the review board for approval.</td> </tr> <tr> <td style="white-space:nowrap">temporarily-closed-to-accrual <a name="research-study-status-temporarily-closed-to-accrual"> </a> </td> <td> Temporarily Closed to Accrual</td> <td> Study is temporarily closed for accrual; can be potentially resumed in the future; patients can be examined and treated.</td> </tr> <tr> <td style="white-space:nowrap">temporarily-closed-to-accrual-and-intervention <a name="research-study-status-temporarily-closed-to-accrual-and-intervention"> </a> </td> <td> Temporarily Closed to Accrual and Intervention</td> <td> Study is temporarily closed for accrual and intervention and potentially can be resumed in the future.</td> </tr> <tr> <td style="white-space:nowrap">withdrawn <a name="research-study-status-withdrawn"> </a> </td> <td> Withdrawn</td> <td> Protocol was withdrawn by the lead organization.</td> </tr> </table> </div> </text> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"> <valueCode value="brr"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="trial-use"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"> <valueInteger value="0"/> </extension> <url value="http://hl7.org/fhir/research-study-status"/> <identifier> <system value="urn:ietf:rfc:3986"/> <value value="urn:oid:2.16.840.1.113883.4.642.1.820"/> </identifier> <version value="4.2.0"/> <name value="ResearchStudyStatus"/> <title value="ResearchStudyStatus"/> <status value="draft"/> <experimental value="false"/> <date value="2019-12-31T21:03:40+11:00"/> <publisher value="HL7 (FHIR Project)"/> <contact> <telecom> <system value="url"/> <value value="http://hl7.org/fhir"/> </telecom> <telecom> <system value="email"/> <value value="fhir@lists.hl7.org"/> </telecom> </contact> <description value="Codes that convey the current status of the research study."/> <caseSensitive value="true"/> <valueSet value="http://hl7.org/fhir/ValueSet/research-study-status"/> <content value="complete"/> <concept> <code value="active"/> <display value="Active"/> <definition value="Study is opened for accrual."/> </concept> <concept> <code value="administratively-completed"/> <display value="Administratively Completed"/> <definition value="Study is completed prematurely and will not resume; patients are no longer examined nor treated."/> </concept> <concept> <code value="approved"/> <display value="Approved"/> <definition value="Protocol is approved by the review board."/> </concept> <concept> <code value="closed-to-accrual"/> <display value="Closed to Accrual"/> <definition value="Study is closed for accrual; patients can be examined and treated."/> </concept> <concept> <code value="closed-to-accrual-and-intervention"/> <display value="Closed to Accrual and Intervention"/> <definition value="Study is closed to accrual and intervention, i.e. the study is closed to enrollment, all study subjects have completed treatment or intervention but are still being followed according to the primary objective of the study."/> </concept> <concept> <code value="completed"/> <display value="Completed"/> <definition value="Study is closed to accrual and intervention, i.e. the study is closed to enrollment, all study subjects have completed treatment or intervention but are still being followed according to the primary objective of the study."/> </concept> <concept> <code value="disapproved"/> <display value="Disapproved"/> <definition value="Protocol was disapproved by the review board."/> </concept> <concept> <code value="in-review"/> <display value="In Review"/> <definition value="Protocol is submitted to the review board for approval."/> </concept> <concept> <code value="temporarily-closed-to-accrual"/> <display value="Temporarily Closed to Accrual"/> <definition value="Study is temporarily closed for accrual; can be potentially resumed in the future; patients can be examined and treated."/> </concept> <concept> <code value="temporarily-closed-to-accrual-and-intervention"/> <display value="Temporarily Closed to Accrual and Intervention"/> <definition value="Study is temporarily closed for accrual and intervention and potentially can be resumed in the future."/> </concept> <concept> <code value="withdrawn"/> <display value="Withdrawn"/> <definition value="Protocol was withdrawn by the lead organization."/> </concept> </CodeSystem>
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.