Site Signature and Delegation Logs

[a123456]

30 Protocols in 2 weeks does sound challenging, in fact does it allow for any "understanding" of the protocols? To comply with GCP it would be necessary to understand and implement the protocols correctly. Staff should be able to do this and answer questions on monitors, auditors and inspectors about the protocols that they are involved with. Obviously staff should be knowledgeable to be able to talk to subjects & others about protocols.

[MonitorH]

Does the Principal Investigator themself need to be listed on the Site Signature and Delegation Log and have relevant duties listed against their name? They are the person doing the delegating, therefore is this required, or is it assumed that the PI may perform all and any duties for which they are qualified?

[plamb]

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.

[snemere]

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?

[Chris Deane]

For one member of staff the PI has predated when they would finish on the study e.g. signed today for finishing in 2 weeks time. Would you have issue with this? I thought it was reasonable for PI to put a finish date in place.

[a123456]

Strange. Pre-dating sounds like an non-GCP Compliant process. Surely the delegated party may well resign from the trial or be determined by the PI that they are no longer GCP compliant and have their duties removed from them, before the theoretical end date.
From a GCP Compliance point of view pre- or post dating anything is open to falsification or fraud. Its almost like a pre-signed financial "blank Cheque", where it can be used at anytime without further authorisation. Signature dates should be contemporaneous so that we know when authorisation has been given, and when authorisation has been withdrawn. It is crazy to assume that once delegation authorisation has been granted that it may not be withdrawn at anytime in the future!

Good idea to read ALL of the things that have been written in this Thread below.

The PI must understand that they are personally responsible for all tasks that they do not delegate in advance. They are also responsible for oversight of all those they have delegated tasks to. The FDA ten point plan for PI oversight says that they should document this oversight!


You should look at the other sections of this MHRA forum -- for instance; PI delegating PI duties; Delegation of duties.