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  1. FHIR Specification Feedback
  2. FHIR-39192

ResearchStudy.comparisonGroup has human specific documentation

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    • Icon: Change Request Change Request
    • Resolution: Persuasive
    • Icon: Medium Medium
    • FHIR Core (FHIR)
    • R5
    • Biomedical Research & Regulation
    • STU
    • DomainResource
      ResearchStudy
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      Existing long definition is:

      Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up

      Change to:

      Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up

      E.g. for a stability study: {Store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}

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      Existing long definition is: Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up Change to: Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up E.g. for a stability study: {Store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}
    • Smita Hastak / Norman Gregory: 8-0-0
    • Clarification
    • Non-substantive
    • R5

    Description

      ComparisonGroup backbone element is designed and documented to be specific to human clinical trials. If ResearchStudy is to be used as base resource for all studies, will need to re-evaluate this backbone element.

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            khalid_shahin Khalid Shahin
            shastak Smita Hastak
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              Updated:
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