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Thread: eCRF and ePRO design - sponsor delegation log

  1. #1

    eCRF and ePRO design - sponsor delegation log

    I would appreciate your thoughts as to when it is most appropriate for the below to be signed onto the sponsor delegation log.

    1. the eCRF/ ePRO creator and
    2. eCRF/ ePRO capture systems staff

    I had thought at early stages during design/ annotation but have heard others say once trial is open.

    Also, the ePROs are annotated for a 3rd party ePRO provider - does the provider need to be on the sp. delegation log or can that be covered by the sponsor staff dealing with the ePRO annotations and UAT?

    Thank you,
    TrialsAdvice

  2. #2
    Dear TrialsAdvice, this is a more general answer. In my understanding delegation is always prospective. As a consequence the documentation (e.g. on a delegation log) should be done before the delegated task is executed.
    Regarding 3rd party provider staff being entered on the sponsor delegation log: it depends. What does your process or your contract say. Depending on the factual situation you may collect a suitable delegation log of your provider and add it to the TMF. Hope this helps.

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