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{ "resourceType" : "CodeSystem", "id" : "research-subject-state", "meta" : { "lastUpdated" : "2020-04-09T21:10:28.568+00:00" }, "text" : { "status" : "generated", "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n \n <h2>ResearchSubjectState</h2>\n \n <div>\n \n <p>Indicates the progression of a study subject through a study.</p>\n\n \n </div>\n \n <p>This code system http://terminology.hl7.org/CodeSystem/research-subject-state defines the following codes:</p>\n \n <table class=\"codes\">\n \n <tr>\n \n <td style=\"white-space:nowrap\">\n \n <b>Code</b>\n \n </td>\n \n <td>\n \n <b>Display</b>\n \n </td>\n \n <td>\n \n <b>Definition</b>\n \n </td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">candidate\n \n <a name=\"research-subject-state-candidate\"> </a>\n \n </td>\n \n <td>Candidate</td>\n \n <td>An identified person that can be considered for inclusion in a study.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">eligible\n \n <a name=\"research-subject-state-eligible\"> </a>\n \n </td>\n \n <td>Eligible</td>\n \n <td>A person that has met the eligibility criteria for inclusion in a study.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">follow-up\n \n <a name=\"research-subject-state-follow-up\"> </a>\n \n </td>\n \n <td>Follow-up</td>\n \n <td>A person is no longer receiving study intervention and/or being evaluated with tests and procedures according to the protocol, but they are being monitored on a protocol-prescribed schedule.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">ineligible\n \n <a name=\"research-subject-state-ineligible\"> </a>\n \n </td>\n \n <td>Ineligible</td>\n \n <td>A person who did not meet one or more criteria required for participation in a study is considered to have failed screening or\nis ineligible for the study.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">not-registered\n \n <a name=\"research-subject-state-not-registered\"> </a>\n \n </td>\n \n <td>Not Registered</td>\n \n <td>A person for whom registration was not completed.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">off-study\n \n <a name=\"research-subject-state-off-study\"> </a>\n \n </td>\n \n <td>Off-study</td>\n \n <td>A person that has ended their participation on a study either because their treatment/observation is complete or through not\nresponding, withdrawal, non-compliance and/or adverse event.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">on-study\n \n <a name=\"research-subject-state-on-study\"> </a>\n \n </td>\n \n <td>On-study</td>\n \n <td>A person that is enrolled or registered on a study.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">on-study-intervention\n \n <a name=\"research-subject-state-on-study-intervention\"> </a>\n \n </td>\n \n <td>On-study-intervention</td>\n \n <td>The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">on-study-observation\n \n <a name=\"research-subject-state-on-study-observation\"> </a>\n \n </td>\n \n <td>On-study-observation</td>\n \n <td>The subject is being evaluated via tests and assessments according to the study calendar, but is not receiving any intervention. Note that this state is study-dependent and might not exist in all studies. A synonym for this is "short-term follow-up".</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">pending-on-study\n \n <a name=\"research-subject-state-pending-on-study\"> </a>\n \n </td>\n \n <td>Pending on-study</td>\n \n <td>A person is pre-registered for a study.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">potential-candidate\n \n <a name=\"research-subject-state-potential-candidate\"> </a>\n \n </td>\n \n <td>Potential Candidate</td>\n \n <td>A person that is potentially eligible for participation in the study.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">screening\n \n <a name=\"research-subject-state-screening\"> </a>\n \n </td>\n \n <td>Screening</td>\n \n <td>A person who is being evaluated for eligibility for a study.</td>\n \n </tr>\n \n <tr>\n \n <td style=\"white-space:nowrap\">withdrawn\n \n <a name=\"research-subject-state-withdrawn\"> </a>\n \n </td>\n \n <td>Withdrawn</td>\n \n <td>The person has withdrawn their participation in the study before registration.</td>\n \n </tr>\n \n </table>\n \n </div>" }, "extension" : [ { "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg", "valueCode" : "brr" }, { "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status", "valueCode" : "draft" }, { "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm", "valueInteger" : 1 } ], "url" : "http://terminology.hl7.org/CodeSystem/research-subject-state", "identifier" : [ { "system" : "urn:ietf:rfc:3986", "value" : "urn:oid:2.16.840.1.113883.4.642.1.0" } ], "version" : "4.2.0", "name" : "ResearchSubjectState", "title" : "ResearchSubjectState", "status" : "draft", "experimental" : false, "date" : "2020-04-09T21:10:28+00:00", "publisher" : "HL7 (FHIR Project)", "contact" : [ { "telecom" : [ { "system" : "url", "value" : "http://hl7.org/fhir" }, { "system" : "email", "value" : "fhir@lists.hl7.org" } ] } ], "description" : "Indicates the progression of a study subject through a study.", "caseSensitive" : true, "valueSet" : "http://terminology.hl7.org/ValueSet/research-subject-state", "content" : "complete", "concept" : [ { "code" : "candidate", "display" : "Candidate", "definition" : "An identified person that can be considered for inclusion in a study." }, { "code" : "eligible", "display" : "Eligible", "definition" : "A person that has met the eligibility criteria for inclusion in a study." }, { "code" : "follow-up", "display" : "Follow-up", "definition" : "A person is no longer receiving study intervention and/or being evaluated with tests and procedures according to the protocol, but they are being monitored on a protocol-prescribed schedule." }, { "code" : "ineligible", "display" : "Ineligible", "definition" : "A person who did not meet one or more criteria required for participation in a study is considered to have failed screening or\nis ineligible for the study." }, { "code" : "not-registered", "display" : "Not Registered", "definition" : "A person for whom registration was not completed." }, { "code" : "off-study", "display" : "Off-study", "definition" : "A person that has ended their participation on a study either because their treatment/observation is complete or through not\nresponding, withdrawal, non-compliance and/or adverse event." }, { "code" : "on-study", "display" : "On-study", "definition" : "A person that is enrolled or registered on a study." }, { "code" : "on-study-intervention", "display" : "On-study-intervention", "definition" : "The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating." }, { "code" : "on-study-observation", "display" : "On-study-observation", "definition" : "The subject is being evaluated via tests and assessments according to the study calendar, but is not receiving any intervention. Note that this state is study-dependent and might not exist in all studies. A synonym for this is \"short-term follow-up\"." }, { "code" : "pending-on-study", "display" : "Pending on-study", "definition" : "A person is pre-registered for a study." }, { "code" : "potential-candidate", "display" : "Potential Candidate", "definition" : "A person that is potentially eligible for participation in the study." }, { "code" : "screening", "display" : "Screening", "definition" : "A person who is being evaluated for eligibility for a study." }, { "code" : "withdrawn", "display" : "Withdrawn", "definition" : "The person has withdrawn their participation in the study before registration." } ] }