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  1. FHIR Specification Feedback
  2. FHIR-38812

AdverseEvent - Section 9.9 & 9.9.1

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    • Icon: Change Request Change Request
    • Resolution: Persuasive
    • Icon: Highest Highest
    • FHIR Core (FHIR)
    • R5
    • Patient Care
    • AdverseEvent
    • 9.9, 9.9.1
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      Update all instances of "research subject" to "research participant" within the narrative (not resource names or structural elements), such as:  An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant

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      Update all instances of "research subject" to "research participant" within the narrative (not resource names or structural elements), such as:  An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant
    • Dan Rutz / Craig Parker : 9-1-0
    • Clarification
    • Non-substantive
    • R5

    Description

      I would recommend using the same term when identifying involvement in clinical research trials. Generally, the trend is to use "participant" over "subject" in human clinical trials. There may be other cases not included in the two examples below.

      Verbatim Example #1:
      "An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research subject."

      {+}Verbatim Example #2:
      {+}"This resource applies to events that occur during the course of medical care or medical research which may impact an individual as the recipient of care or the participant in a research study. "

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            mhamidi Mike Hamidi
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