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 (FHIR)
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current
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Biomedical Research & Regulation
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Withdrawn
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AdverseEvents for Clinical Research Home Page
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Peter Bomberg / Rebecca Baker : 16 - 0 - 2
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Clarification
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Non-substantive
Description
The Scope section is not as clear as it should be. Perhaps the Scope is meant to be the collection/representation of AEs in EHRs for both premarket and postmarket safety reporting to support patient safety protection and regulatory review and evaluation. Anyway, a clearer description of the Scope would be desirable.
Attachments
Issue Links
- is voted on by
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BALLOT-51637 Negative - Mitra Rocca : 2023-Sep-FHIR IG AECR R1 STU
- Withdrawn
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BALLOT-52492 Negative - Edward Bearden : 2023-Sep-FHIR IG AECR R1 STU
- Withdrawn
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BALLOT-52502 Negative - Norman Gregory : 2023-Sep-FHIR IG AECR R1 STU
- Withdrawn
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BALLOT-52532 Negative - Marti Velezis : 2023-Sep-FHIR IG AECR R1 STU
- Withdrawn
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BALLOT-52542 Negative - Konstantinos Makrodimitris : 2023-Sep-FHIR IG AECR R1 STU
- Withdrawn
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BALLOT-52512 Negative - William Hess : 2023-Sep-FHIR IG AECR R1 STU
- Balloted
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BALLOT-52522 Negative - Ronald Claros : 2023-Sep-FHIR IG AECR R1 STU
- Balloted
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BALLOT-52552 Negative - Jose Galvez : 2023-Sep-FHIR IG AECR R1 STU
- Balloted