The guidance on Investigator Responsibilities states that “The investigator should maintain a list of the appropriately qualified persons to whom significant trial-related duties have been delegated.” Note the word ‘significant.’
While this FAQ guidance is specifically talking about the Form FDA 1572, note that the FDA is clear that persons who “provide ancillary or intermittent care but who do not make a direct and significant contribution to the clinical data, do not need to be listed individually.” In reality, short of adding the entire hospital staff to a DOA log, it is nearly impossible to account for who may be administering agents as part of their clinical duties (especially for inpatient studies). A good rule of thumb is whether that staff member is making a direct and significant contribution to the clinical data. Those persons should be considered key staff and included on the DOA log.
