Details
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Change Request
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Resolution: Unresolved
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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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1.4.1 and 2.2
Description
Are any of the algorithms listed evaluated for accuracy? Sensitivity/specificity so users know what the margin of error is for automated detection of a reported case? Comparison of reported instances to detected instances by the IG?
Existing Wording:
NA
Proposed Wording:
NA
(Comment 3 - imported by: Chris Shawn)
Attachments
Issue Links
- is voted on by
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BALLOT-20911 Affirmative - Chris Shawn : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21934 Affirmative - Keith Salzman : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21937 Affirmative - Keith E. Campbell : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21940 Affirmative - Vannak Kann : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21943 Affirmative - Sean Muir : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21946 Affirmative - Mohammad Jafari : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21949 Affirmative - Javon Hyland : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21952 Affirmative - Matthew Greene : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21955 Affirmative - Kathleen Connor : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21958 Affirmative - Ioana Singureanu : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21961 Affirmative - Holly L. Miller : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21964 Affirmative - Galen Mulrooney : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21967 Affirmative - Dave Carlson : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted
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BALLOT-21970 Affirmative - Catherine Hoang : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted