Recommended Text:
"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)."
bheale
commented
1 year ago
URL: http://build.fhir.org/ig/HL7/fhir-ae-research-ig/branches/master/ValueSet-adverse-event-seriousness-criteria-vs.html#root Comment: The current reference is to ICH E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files, which should be updated to indicate ICH E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting. The link is correct.
Existing Text: This list comes from ICH E2B R3 (https://database.ich.org/sites/default/files/E2D_Guideline.pdf).
Recommended Text: "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)."