XMLWordPrintableJSON

Details

    • Icon: Change Request Change Request
    • Resolution: Persuasive
    • Icon: Highest Highest
    • Adverse Event Clinical Research R4 Backport (FHIR)
    • 1.0.0-ballot [deprecated]
    • Biomedical Research & Regulation
    • AdverseEvents for Clinical Research Home Page
    • Home - 1.3 Scope - 1st Paragraph
    • Hide

      Will change to  "As the AEs are collected in RWD sources, the data can be transmitted via FHIR to sponsors, regulatory agencies, and clinical research organizations for further processing and reporting."

      Show
      Will change to  "As the AEs are collected in RWD sources, the data can be transmitted via FHIR to sponsors, regulatory agencies, and clinical research organizations for further processing and reporting."
    • Peter Bomberg / Rebecca Baker : 16 - 0 - 2
    • Clarification
    • Non-substantive

    Description

      Recommend revising wording from "As the AEs are collected in RWD sources, the data can be transmitted via FHIR to clinical trial management systems, regulatory agencies, sponsors, and clinical research organizations for further processing and reporting." to "As the AEs are collected in RWD sources, the data can be transmitted via FHIR to sponsors, regulatory agencies, and clinical research organizations for further processing and reporting."

      In the original wording, we are mentioning the CTMS which is a technology solution, whereas, the other references are organizations and agencies. If specific generic technology solutions should be called out, then add them as a separate sentence or paragraph. 

      Attachments

        Activity

          People

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

            Dates

              Created:
              Updated:
              Resolved: