Details
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Change Request
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Resolution: Persuasive
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Highest
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US ICSR Transfusion and Vaccination Adverse Event Detection and Reporting (FHIR)
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0.1.0
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Biomedical Research & Regulation
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Overview
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1.1
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Jean Duteau / Peter Bomberg : 14-0-1
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Clarification
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Non-substantive
Description
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), ich.org FDA Adverse Event Reporting System (FAERS). Vaccine Adverse Event Reporting System (VAERS)
Existing Wording:
ICH, FAERS, VAERS,
Proposed Wording:
see comment
(Comment 2 - imported by: Chris Shawn)
Attachments
Issue Links
- is voted on by
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BALLOT-20910 Affirmative - Chris Shawn : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21935 Affirmative - Keith Salzman : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21938 Affirmative - Keith E. Campbell : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21941 Affirmative - Vannak Kann : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21944 Affirmative - Sean Muir : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21947 Affirmative - Mohammad Jafari : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21950 Affirmative - Javon Hyland : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21953 Affirmative - Matthew Greene : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21956 Affirmative - Kathleen Connor : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21959 Affirmative - Ioana Singureanu : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21962 Affirmative - Holly L. Miller : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21965 Affirmative - Galen Mulrooney : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21968 Affirmative - Dave Carlson : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21971 Affirmative - Catherine Hoang : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted