Site Signature and Delegation Logs

[a123456]

You just need to use logic.
As you said the PI must authorise the staff delegated to do duties, before they conduct those duties. There is no need to have all signatures on the same date, just need to make sure they are in the right order. Staff must be trained and authorised by the PI and sign the delegation log themselves before they perform the duties. Ideally the PI should sign to authorise staff after they are suitably trained, but before they perform the duty. Have a look in the MHRA GCP Guide (2012)

[plamb]

Hi a123456,

Many thanks for your advice. We have 30 ongoing clinical trials (with active recruitment); all subinvestigators (each sub inv works in the unit for only 1 year and the post will be replaced by a new one) and all research nurses will have chance to see any trial subjects. I'm aware that all signatures will not have to be on the same day but at the same time we can't have one staff signature, then obtain PI's then find other staff and so on. In the beginning I did not think it was difficult until I worked here!

Anyway, I'm thinking I should implement a strict process of which no staff will perform their duties (of 30 trials!) until they have protocol trainings, sign in delegation log and are authorised by PI (hopefully PI is not away). For a new staff to read 30 protocols within 2 weeks is quite challenging I must admit.

[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.