Details
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Change Request
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Resolution: Persuasive
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Very High
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FHIR Core (FHIR)
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R5
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Biomedical Research & Regulation
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DomainResource
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Brian Alper / Joanne Dehnbostel : 17 - 0 - 0
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Clarification
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Non-substantive
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R5
Description
1. Remove the type of blinding and type of randomization examples from definition
2. Add FDA regulated device, FDA regulated drug, MPG Paragraph 23b (German legal requirement), IRB-exempt, as examples
3. Delete the values from ResearchStudy Classifiers Code system ( https://build.fhir.org/valueset-research-study-classifiers.html) and ADD the four values from #2 above
Will send definitions for the 4 values in email