eCRF and ePRO design - sponsor delegation log

[TrialsAdvice]

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

[Margit Zehrer]

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.