This is an essential document used by a study team to outline each individuals’ roles and responsibilities on a study.
The delegation log 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.
The delegation log should be kept up to date at all times (real-time as demonstrates oversight), for example, when a member of staff leaves or is no longer working on the study in the same capacity this should be recorded. Delegation logs and all supporting evidence should be retained by the Chief Investigator in the Trial Master File for co-ordinating centre delegated activities and by the Principal Investigator in the Investigator Site File (ISF) for site delegated activities, all documents should be available for review (or provided) on request by the sponsor.