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.
Implications of non-delegated staff working on the trial
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.