| Source | hl7.fhir.uv.ae-research-ig#current:Adverse Event Clinical Research (v5.0.0) |
| resourceType | ValueSet |
| id | adverse-event-causality-related-vs |
| canonical | http://hl7.org/fhir/uv/ae-research-ig/ValueSet/adverse-event-causality-related-vs |
| version | 1.0.0-ballot |
| status | draft |
| publisher | HL7 International - Biomedical Research and Regulation, Vulcan AdverseEvent groups |
| name | CausalityRelatedness |
| title | Causality Relatedness values |
| date | 2023-07-28T19:27:19+00:00 |
| experimental | true |
| description | Value set for stating if a suspected entity is Not Related, Unlikely Related, Possibly Related, or Related to the cause of the adverse event. Using NCI codes. The values originate with ICH. 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 | |