{
"description": "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"_filename": "CodeSystem-research-study-registration-activity.json",
"package_name": "hl7.fhir.uv.extensions",
"date": "2022-05-15T16:55:11.085+11:00",
"meta": {
"profile": [ "http://hl7.org/fhir/StructureDefinition/shareablecodesystem" ],
"lastUpdated": "2022-05-15T16:55:11.085+11:00"
},
"publisher": "HL7 International / Biomedical Research and Regulation",
"jurisdiction": [ {
"coding": [ {
"code": "001",
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm"
} ]
} ],
"content": "complete",
"name": "ResearchStudyRegistrationActivity",
"type": null,
"experimental": "false",
"resourceType": "CodeSystem",
"title": "ResearchStudy Registration Activity Code System",
"package_version": "5.3.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "trial-use"
}, {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 1
} ],
"status": "active",
"id": "c39a16bc-4b59-4fc9-88f4-90669d2eab18",
"valueSet": "http://hl7.org/fhir/ValueSet/research-study-registration-activity",
"kind": null,
"url": "http://hl7.org/fhir/research-study-registration-activity",
"identifier": [ {
"value": "urn:oid:2.16.840.1.113883.4.642.4.2124",
"system": "urn:ietf:rfc:3986"
} ],
"concept": [ {
"code": "record-verification",
"display": "Record Verification",
"definition": "Record has been verified."
}, {
"code": "primary-outcome-data-collection",
"display": "Primary outcome data collection",
"definition": "The data has been obtained for the primary outcomes from all participants."
}, {
"code": "registration-submission",
"display": "Registration submission",
"definition": "The initial record has been submitted for registration."
}, {
"code": "registration-submission-qc",
"display": "Registration submission Quality Check",
"definition": "The initial record submission has been confirmed to meet acceptance criteria for registration."
}, {
"code": "registration-posting",
"display": "Registration posting",
"definition": "The initial record has been registered and published."
}, {
"code": "results-submission",
"display": "Results submission",
"definition": "Study results have been submitted."
}, {
"code": "results-submission-qc",
"display": "Results submission Quality Check",
"definition": "The submitted study results have been confirmed to meet acceptance criteria for publication."
}, {
"code": "results-posting",
"display": "Results posting",
"definition": "Study results have been published in the registry."
}, {
"code": "disposition-submission",
"display": "Disposition submission",
"definition": "A request for deferral of study submission requirements has been submitted."
}, {
"code": "disposition-submission-qc",
"display": "Disposition submission Quality Check",
"definition": "The submitted request for deferral of study submission requirements has been confirmed for acceptance for publication."
}, {
"code": "disposition-posting",
"display": "Disposition posting",
"definition": "The request for deferral of study submission requirements has been published in the registry."
}, {
"code": "update-submission",
"display": "Update submission",
"definition": "An update to the record has been submitted."
}, {
"code": "update-posting",
"display": "Update posting",
"definition": "An update to the record has been published in the registry."
} ],
"caseSensitive": true,
"version": "5.3.0",
"contact": [ {
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
} ]
} ]
}