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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
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Definition for Code SystemResearchStudyStatus
<?xml version="1.0" encoding="UTF-8"?> <CodeSystem xmlns="http://hl7.org/fhir"> <id value="research-study-status"/> <meta> <lastUpdated value="2023-03-26T09:21:02+05:00"/> <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> </meta> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"> <p> This code system <code> http://hl7.org/fhir/research-study-status</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">overall-study <a name="research-study-status-overall-study"> </a> </td> <td> Overall study</td> <td> Used for documenting the start and end of the overall study, distinct from progress states.</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">active-but-not-recruiting <a name="research-study-status-active-but-not-recruiting"> </a> </td> <td> Active, not recruiting</td> <td> The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.</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> The study closed according to the study plan. There will be no further treatments, interventions or data collection.</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">enrolling-by-invitation <a name="research-study-status-enrolling-by-invitation"> </a> </td> <td> Enrolling by invitation</td> <td> The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.</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">not-yet-recruiting <a name="research-study-status-not-yet-recruiting"> </a> </td> <td> Not yet recruiting</td> <td> The study has not started recruiting participants.</td> </tr> <tr> <td style="white-space:nowrap">recruiting <a name="research-study-status-recruiting"> </a> </td> <td> Recruiting</td> <td> The study is currently recruiting participants.</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">terminated <a name="research-study-status-terminated"> </a> </td> <td> Terminated</td> <td> The study has stopped early and will not start again. Participants are no longer being examined or treated.</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:2.16.840.1.113883.4.642.4.820"/> </identifier> <identifier> <use value="old"/> <system value="urn:ietf:rfc:3986"/> <value value="urn:oid:2.16.840.1.113883.4.642.1.803"/> </identifier> <version value="5.0.0"/> <name value="ResearchStudyStatus"/> <title value="Research Study Status"/> <status value="active"/> <experimental value="false"/> <date value="2021-01-05T10:01:24+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."/> <jurisdiction> <coding> <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/> <code value="001"/> <display value="World"/> </coding> </jurisdiction> <caseSensitive value="true"/> <valueSet value="http://hl7.org/fhir/ValueSet/research-study-status"/> <content value="complete"/> <concept> <code value="overall-study"/> <display value="Overall study"/> <definition value="Used for documenting the start and end of the overall study, distinct from progress states."/> </concept> <concept> <code value="active"/> <display value="Active"/> <definition value="Study is opened for accrual."/> </concept> <concept> <code value="active-but-not-recruiting"/> <display value="Active, not recruiting"/> <definition value="The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled."/> </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="The study closed according to the study plan. There will be no further treatments, interventions or data collection."/> </concept> <concept> <code value="disapproved"/> <display value="Disapproved"/> <definition value="Protocol was disapproved by the review board."/> </concept> <concept> <code value="enrolling-by-invitation"/> <display value="Enrolling by invitation"/> <definition value="The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate."/> </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="not-yet-recruiting"/> <display value="Not yet recruiting"/> <definition value="The study has not started recruiting participants."/> </concept> <concept> <code value="recruiting"/> <display value="Recruiting"/> <definition value="The study is currently recruiting participants."/> </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="terminated"/> <display value="Terminated"/> <definition value="The study has stopped early and will not start again. Participants are no longer being examined or treated."/> </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.
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