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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,

  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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