As monitors, we come across this question from time to time…Is a Delegation log required?
The principal investigator is ultimately responsible for the conduct of the study, but it is common for the PI to delegate certain study-related tasks to other members of the research team (co-investigators, coordinators, lab personnel, etc.). How should a PI properly document these delegated tasks?
Delegation logs are not addressed in FDA’s Federal Regulations (21 CFR 312 and 812); therefore a delegation log is not a federal requirement. Although it would be unlikely for an FDA auditor to request to see the site’s delegation log, the auditor should ask for a list of delegated tasks as referenced in the BIMO checklist.
However, per ICH GCP E6 4.1.5, the investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties. Per FDA’s Guidance for Industry- Investigator Responsibilities, the list should also describe the delegated tasks, identify the training that individuals have received that qualifies them to perform the delegated tasks, and identify the dates of involvement in the study. A separate list should be maintained for each study conducted by the investigator.
ICH GCP E6 also provides a list of Essential Documents for the Conduct of a Clinical Study. A delegation log is not listed. However, a signature sheet to document signatures and initials of all persons authorized to make entries and/or correction on CRFs is listed (8.3.24).
Although a delegation log may not be a federal requirement, it may be a Sponsor requirement. If the Sponsor requires a completed delegation log, then a site will need to complete and maintain the log.
A delegation log may also be part of a site’s standard operating procedures. In this case, it would need to be completed and maintained as well.
So, although a delegation log is not required per federal regulations, Good Clinical Practice suggests documenting the PI’s delegation of tasks to other members of the research team. And a site must always follow the Sponsor’s and their SOPs.
Do you get this question when working with sites? How do you enforce the completion of a delegation log? Please share your stories with us.
Photo Credit: Elvert Barnes