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 Composition
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Jean Duteau / Peter Bomberg : 14-0-1
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Clarification
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Non-substantive
Description
It would be helpful for readers if the various sections in the ICSR Composition profile had some guidance on how to populate them. For example, the Patient section seems to have an .entry element that is constrained to Observation. What sort of Observations might be expected on the patient? Similarly, InCaseOfDeath is also constrained to an Observation. And ParentInformation can be a Patient, Condition or MedicationStatement (not of which matches my first thought of the parent of the patient). Please clarify how to use the various sections of the Composition.
Attachments
Issue Links
- is voted on by
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BALLOT-20923 Affirmative - Craig Newman : 2021-Sep-FHIR IG ICSR AE REPORT R1 STU
- Balloted