Details
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Change Request
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Resolution: Persuasive
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Highest
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Adverse Event Clinical Research R4 Backport (FHIR)
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1.0.0-ballot [deprecated]
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Biomedical Research & Regulation
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AdverseEvents for Clinical Research Home Page
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Home - 1.3 Scope - 1st Paragraph
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Peter Bomberg / Rebecca Baker : 16 - 0 - 2
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Clarification
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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
Issue Links
- relates to
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FHIR-42088 Several updates associated with FHIR IG R4 Backport & R5
- Published