Details
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Change Request
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Resolution: Not 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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1.2
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Jean Duteau / Norman Gregory : 16-0-0
Description
What is the cause for underreporting-is it the burden of generating a report by busy clinicians, lack of awareness of reporting criteria? Has a root cause analysis been done to address the sources so that automated detection is not just adding more tasks for a clinician that is not reporting for whatever reason?
Existing Wording:
…may be underreported and the data reported may not always contain adequate information for decision-making.
Proposed Wording:
NA
(Comment 1 - imported by: Chris Shawn)
Attachments
Issue Links
- is voted on by
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BALLOT-20909 Affirmative - Chris Shawn : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21936 Affirmative - Keith Salzman : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21939 Affirmative - Keith E. Campbell : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21942 Affirmative - Vannak Kann : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21945 Affirmative - Sean Muir : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21948 Affirmative - Mohammad Jafari : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21951 Affirmative - Javon Hyland : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21954 Affirmative - Matthew Greene : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21957 Affirmative - Kathleen Connor : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21960 Affirmative - Ioana Singureanu : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21963 Affirmative - Holly L. Miller : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21966 Affirmative - Galen Mulrooney : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21969 Affirmative - Dave Carlson : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21972 Affirmative - Catherine Hoang : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted