Uploaded image for project: 'FHIR Specification Feedback'
  1. FHIR Specification Feedback
  2. FHIR-42086

FDA Additional Seriousness Criteria CodeSystem

    XMLWordPrintableJSON

Details

    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Low Low
    • Adverse Event Clinical Research R4 Backport (FHIR)
    • 1.0.0-ballot [deprecated]
    • Biomedical Research & Regulation
    • FDA Additional Seriousness Criteria CodeSystem [deprecated]
    • Hide

      A new NCI C-code has been requested by FDA and will replace the code in the IG.

      There will not need to be a new FDA code set, we will request that the FDA code is added with the other seriousness criteria.

      Show
      A new NCI C-code has been requested by FDA and will replace the code in the IG. There will not need to be a new FDA code set, we will request that the FDA code is added with the other seriousness criteria.
    • Michelle Casagni / Rebecca Baker : 13 - 0 - 0
    • Enhancement
    • Non-substantive

    Description

      Where did the FDA Additional Seriousness Criteria CodeSystem for "requiresPreventImpairment" get used in this IG? There's a mention this is generally used as a post-market surveillance measure via FDA MedWatch 3500A. 

      Attachments

        Activity

          People

            bheale Bret Heale
            mhamidi Mike Hamidi
            Watchers:
            3 Start watching this issue

            Dates

              Created:
              Updated:
              Resolved: