Site Signature and Delegation Logs

I do a lot of audits of investigator site files as part of site audits and consistently find the following issues:

1. Staff listed but not signed off as approved for the delgated tasks until after they have been working on the trial for a period of time (often several weeks)

2. Staff not listed at all, even though they have clearly performed study related tasks.

At close out meetings, these sites often ask me if I know of any systems they can out in place to ensure this doesn't happen in the future.

Has anyone come across any systems that stood out as an effective system for having control of these? If so, I would appreciate hearing of them. Thanks.

This is a common Inspection finding.
What system does the site have for training & familarising new staff with the study? If they link signing of the delegation log to that training then they will have delegation before performance of the task.
Of course that does rely upon the site training or familarising staff with the project [U]before[/U] they do any study related activities.
Best if the institution has an SOP which requires training & delegation (& approval of delegation by PI and acceptance of the delegated tasks by the delegate) before staff are alocated to studies. This could also be part of the process of establishing that the staff are adequately experienced, educated and trained for such tasks and collection of their CVs, and job descriptions. If there is a checklist associated with this SOP then only those staff who have done all the things on the checklist are allowed to perform study related activities.
A bigger problem is the training of the PI to monitir and enforce his/her delegation of duties. 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!

If the principal investigator (PI) deems certain members of staff unsuitable/ incompetent to have study-related duties to be delegated to but he/she is under pressure by management to do so, what should the PI do?

As the PI holds the final responsibility, can the PI overturn management decision?

What are the implications, from a regulatory perspective, should a staff member perform duties that they were not delegated by the PI? Either the PI had not deemed the staff competent to perform those duties or the PI decided to end the delegated duties that were once delegated for competence reasons.
What are the implications for:
1) the PI
2) the staff member who performed undelegated duties
3) the clinical trial site/management/ CEO of company?

Many thanks for your guidance.

I am looking forward for one such system as well, did you make any headway?[QUOTE=qalassinoz;1161]I do a lot of audits of investigator site files as part of site audits and consistently find the following issues:

1. Staff listed but not signed off as approved for the delgated tasks until after they have been working on the trial for a period of time (often several weeks)

2. Staff not listed at all, even though they have clearly performed study related tasks.

At close out meetings, these sites often ask me if I know of any systems they can out in place to ensure this doesn't happen in the future.

Has anyone come across any systems that stood out as an effective system for having control of these? If so, I would appreciate hearing of them. Thanks.[/QUOTE]

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

The MHRA GCP Guide (2012) states:- In relation to a clinical trial, the term ‘investigator’ in Regulation 2 of SI 2004/1031 is defined as: ‘ the authorised health professional responsible for the conduct of that trial at a trial site, and if the trial is conducted by a team of authorised health professionals at a trial site, the investigator is the leader responsible for that team’. It does not say the PI is the leader responsible for that team unless he/she is put under pressure by their management! GCP inspectors all over the world have issued inspection findings and Warning Letters when a PI is not exercising their responsibilities as the leader of the clinical research team. So I think the answer is self evident.

The MHRA GCP Guide makes it clear that they anticipate that only the PI will delegate duties to their staff (11.3.4) :- "In order to demonstrate that the PI has authorised appropriately trained and qualified individuals to undertake certain trial related tasks, a delegation of authority log is used at the site. This document may be combined with the site staff signature log, but should clearly state the name of the person, their role and the activities they are delegated by the PI as well as being signed and dated by the PI prior to the activity being undertaken by the individual. It is not acceptable for the PI to simply sign-off the delegation log at the end of the trial. The delegation is not just a paper exercise; it is documented evidence of appropriate delegation of investigator’s responsibilities".

RQA (formally BARQA) answered a similar question on their GCP website ([url]www.theRQA.com[/url]), about the PI delegating their duty of signing the protocol or alternative contract, to show their agreement. You may find that useful.

If you read the other sections of this MHRA Form you will see that the views are consistent:- The PI should not delegate duties to those who are not appropriate and should withdraw duties from those he/she deems to not be carrying them out according to GCP, legislative requirements and the protocol.

Hi,

May I ask for your advice/comment please? I'm a (NHS) site staff. My unit conducts clinical trials only and most trials are sponsored by pharma companies. We have 4 PIs, 10 sub inv (not permanent post), 25 research nurses, 10 data entry staff, and 8 trial coordinators.

Each sponsor has their own delegation log. Each staff entry has to be authorized by the PI (i.e. PI signed and dated before they are involved in each study.). The issue is PI signs and dates a week later (not the same day that each site staff signs). It is very difficult to have it the same day as we have to get all staff to sign and it might take a week.

I completely agree with a123456 that delegation log is not just a paper excercise. There are four dates which they should go together; protocol training date, staff's signature date in delegation log, authorized date by PI in delegation log, and the first date each staff sees patients. I must admit to you that with the large number of site staff, it is so difficult to have all these dates perfect. I'm still working on it:(

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)

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.

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.

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?

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.

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?

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.

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.