Good Clinical Practice Guide
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Thread: Site Signature and Delegation Logs

  1. #11
    Forum Member
    Join Date
    Nov 2011
    I'm an investigator site and we work for many pharma sponsors/CROs. Some delegation logs from some sponsors/CROs have a separate section at the top of the log for only PI to sign and there is no column for authorization. Some logs need us to list tasks for PI but some logs have pre-printed saying "As a PI, I have responsibilities and oversee all tasks....." I consider it is appropriate to list PI in the delegation log but happy to hear other people's opinion too.

  2. #12
    Forum Member
    Join Date
    Jan 2016
    I had an audit where a minor finding was that the PI had not been listed among the study site team members for whom the PI delegated study related tasks. (All other necessary signatures have been available, delegation process had been performed accordingly) I have read the related ICH-GCP intrsuction. According to my understanding there is no definite requirement is included. As I can see I am not only one who is uncertain in this matter. Can anyone help?

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