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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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
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.
Attachments
Issue Links
- is voted on by
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BALLOT-51634 Affirmative - Mitra Rocca : 2023-Sep-FHIR IG AECR R1 STU
- Balloted
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BALLOT-52495 Affirmative - Edward Bearden : 2023-Sep-FHIR IG AECR R1 STU
- Balloted
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BALLOT-52505 Affirmative - Norman Gregory : 2023-Sep-FHIR IG AECR R1 STU
- Balloted
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BALLOT-52515 Affirmative - William Hess : 2023-Sep-FHIR IG AECR R1 STU
- Balloted
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BALLOT-52525 Affirmative - Ronald Claros : 2023-Sep-FHIR IG AECR R1 STU
- Balloted
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BALLOT-52535 Affirmative - Marti Velezis : 2023-Sep-FHIR IG AECR R1 STU
- Balloted
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BALLOT-52545 Affirmative - Konstantinos Makrodimitris : 2023-Sep-FHIR IG AECR R1 STU
- Balloted
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BALLOT-52555 Affirmative - Jose Galvez : 2023-Sep-FHIR IG AECR R1 STU
- Balloted