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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ICSR Seriousness Codes
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Jean Duteau / Peter Bomberg : 14-0-1
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Clarification
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Non-substantive
Description
Users might benefit for some additional guidance on how to use the Seriousness codes. Comparing these to the VAERS form section 21, it seems like all of the concepts are there, but just having a code for "Emergency Room" is ambiguous. I assume this means that the adverse event resulted in the subject having to visit the ER. If so, some clarification would be helpful.
As well, please distinguish between the use of 33 (RequiresInpatientHospitalization) and C50414 (Hospitalization Required). Are these synonyms and fully interchangeable? If so, why have both? Or is there a subtle distinction? If so, what is that distinction.
Attachments
Issue Links
- is voted on by
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BALLOT-20918 Affirmative - Craig Newman : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted