Details
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Change Request
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Resolution: Persuasive with Modification
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Medium
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FHIR Core (FHIR)
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R4
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Biomedical Research & Regulation
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ResearchSubject
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Brian Alper / Catherine Hosage-Norman : 11 - 0 - 0
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Clarification
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Non-substantive
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R5
Description
Current text in 8.23 and 8.23.1 is not a correct definition. Replace with
8.23 Resource ResearchSubject - Content
A ResearchSubject is a participant or object which is the recipient of investigative activites in a research study
8.23.1 Scope and Usage
A research subject is typically a human being or an animal, but can also be a device, drug product or biological product, substance, or a tissue or other sort of sample. Research subject can also be a group or part of any of the above.
(what about environmental studies? location?)
The ResearchSubject resource describes essential information about the subject in the context of a research study. (maybe use code value pairs)
Human research subjects are traceable to a particular person but their identifying characteristics are usually hidden to protect study integrity and to protect the subject’s privacy.
Note that in a human drug trial the human is the research subject even though the drug is what is being investigated.
This is the start of revision of the Scope and Usage section - there will be further extensions to look at a series of use cases, the initial thought is:
The scope of ResearchSubject is intended to support the following use cases:
- Clinical trials (human and vetirinary)
- Pre-clinical trials
- Drug Product
- Stability studies on drug products
- Device ....
- Other bench research related to specimen
- Tissue
...