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  1. FHIR Specification Feedback
  2. FHIR-42037

primary vs. secondary clinical trial management system

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    • Icon: Change Request Change Request
    • Resolution: Persuasive
    • Icon: Highest Highest
    • Adverse Event Clinical Research (FHIR)
    • current
    • Biomedical Research & Regulation
    • AdverseEvents for Clinical Research Home Page
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    • Peter Bomberg / Rebecca Baker : 16 - 0 - 2
    • Clarification
    • Non-substantive

    Description

      By using this IG, a clinical investigator can document an AE in the EHR system, it can be received by a secondary clinical trial management system for triage and then forwarded to the sponsor and regulatory agencies
      Where is the primary clinical trial management system? The primary system is an Electronic Data Capture (EDC) system.

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            bheale Bret Heale
            mrocca Mitra Rocca
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              Updated:
              Resolved: