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Type:
Change Request
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Resolution: Persuasive with Modification
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Priority:
Medium
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FHIR Core (FHIR)
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R5
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Biomedical Research & Regulation
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ResearchStudy
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- Planned and actual subject numbers are dealt with through recruitment
- will add a parallel siteRecruitment extension that includes a markdown element to specify the inclusion/exclusion criteria
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Smita Hastak / Catherine Hosage-Norman : 19-0-0
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Enhancement
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Compatible, substantive
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Yes
Propose adding ResearchStudy.SiteQuantity and ReserachStudy.SubjectQuantity. Cardinality 0..* and include value, type, date.
As a sponsor, this would allow us to submit planned and enrolled site and subject quantities to clinical trial registries such as clinicaltrials.gov
