| Source | hl7.fhir.uv.ae-research-ig#current:Adverse Event Clinical Research (v5.0.0) |
| resourceType | ValueSet |
| id | adverse-event-seriousness-criteria-vs |
| canonical | http://hl7.org/fhir/uv/ae-research-ig/ValueSet/adverse-event-seriousness-criteria-vs |
| version | 1.0.0-ballot |
| status | draft |
| publisher | HL7 International - Biomedical Research and Regulation, Vulcan AdverseEvent groups |
| name | AdverseEventSerCrit |
| title | Adverse Event Seriousness Criteria |
| date | 2023-07-28T19:27:19+00:00 |
| experimental | true |
| description | Action criteria usually associated with serious events that pose a threat to a patient's life or functioning. Adverse Events criteria to expand on the seriousness of the adverse event. Typically used in reporting for Clinical Research, post-market surveillance (e.g. Form FDA 3500A MedWatch). The adverse event seriousness criteria value set is based on the ICH E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting guidance (https://database.ich.org/sites/default/files/E2D_Guideline.pdf). 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 | |