| Source | hl7.fhir.uv.ae-research-backport-ig#current:Adverse Event Clinical Research R4 Backport (v4.0.1) |
| resourceType | ValueSet |
| id | adverse-event-outcome-clinical-research-vs |
| canonical | http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-outcome-clinical-research-vs |
| version | 1.0.0-ballot |
| status | draft |
| publisher | HL7 International - Biomedical Research and Regulation, Vulcan AdverseEvent groups |
| name | OutcomeAEClinRes |
| title | Adverse Event Clinical Research Outcomes |
| date | 2023-07-28T19:26:02+00:00 |
| experimental | true |
| description | This value set includes codes that describe the type of outcome from the adverse event as typically used in reporting for Clinical Research, post-market surveillance (e.g. Medwatch forms). NCI codes used here This list originates from the ICH E2B R3 (https://database.ich.org/sites/default/files/E2D_Guideline.pdf), specifically CDISC CL.C66768.OUT. For information on ICH see https://admin.ich.org/sites/default/files/inline-files/OID_Information_Paper_1.pdf from the INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE (ICH) document ICH E2B(R3), the Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide Data Elements and Message Specification, and ICH M8, the Electronic Common Technical Document. |
| jurisdictions | uv |
| Usages | |