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Specification:

Adverse Event Clinical Research (FHIR)
Raised in Version:

1.0.0-ballot [deprecated]
Work Group:

Biomedical Research & Regulation
Outstanding Negatives:
STU
Related Artifact(s):

Adverse Event Clinical Research
Related Page(s):

AdverseEvents for Clinical Research Home Page
Grouping:
- Narrative
Resolution Description:

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The point is a very important one. There is a separate guide for clinical care that could be further developed (https://build.fhir.org/ig/HL7/fhir-ae-care-ig/). However, the clinical research IG is focused on clinical research.

no action in the Clinical Research IG to be taken

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The point is a very important one. There is a separate guide for clinical care that could be further developed ( https://build.fhir.org/ig/HL7/fhir-ae-care-ig/ ). However, the clinical research IG is focused on clinical research. no action in the Clinical Research IG to be taken
Resolution Vote:
Michelle Casagni / Rabecca Baker : 15 - 0 - 3

The use cases, examples, and diagrams are explained well and cover the common scenarios. Some clinical information systems consider automated triggers (as clinical decision support) to recommend the potential for adverse events to clinicians to generate review and both reporting and mitigation. Discussion about use of such automated triggers and possibly including the concept in an example scenario will be helpful.
The post-market surveillance scenarios presented can also be applied to routine clinical care. Identified adverse events with suspected medication causative agents may lead to MedWatch reporting; however, the scenario may provide sufficient information to capture patient-specific adverse events as well. While such use is not necessarily in your immediate scope, some discussion about application of the scenarios to routine practice will be helpful for the non-research community. This is especially true as we consider the Learning Health System in which clinical outcomes should feed further research and clinical guideline updates.
Reviewing Adverse Event modeling in FHIR R4 (maturity level 0) and FHIR R5 (maturity level 2) it is clear why you used FHIR R5 as the model for your Adverse Event Clinical Research. Can you add discussion about how your new profile might be used by clinical care and re-used by non-research-related IGs to avoid the need for multiple such hybrid AdverseEvent profiles with extensions to emulate the FHIR R5 modeling?

is voted on by

BALLOT-51604 Negative - Floyd Eisenberg : 2023-Sep-FHIR IG AECR R1 STU