Taking the same guidance documents listed above, persons who have “significant trial-related duties” (Investigator Responsibilities) or who “make a direct and significant contribution to the clinical data” (FAQ) should be on the DOA log. In my own, honest, opinion, I would expect to see the primary research coordinator(s) who are involved with collecting data, the investigators taking and noting results of surveys/procedures/tests, persons involved with any data analysis to be included (note that this is not an exhaustive list). It is impossible to come up with a yay/nay list solely due to the diversity of research conducted and how the nuances of each project can affect who is significantly contributing to its conduct. This is also why it is important to consider the DOA log on a protocol-by-protocol basis. A qualified individual on one type of study may not be qualified on another study (due to things like complexity of procedures, licensure requirements, survey or equipment administration expertise, etc.)
Standard operating procedures (SOPs) and departmental policies regarding who is on a DOA log should take into consideration all of these guidance documents to ensure that they are in compliance with ICH and FDA guidance (I personally recommend actually citing these documents and sections in the SOP to show that they have been taken into consideration). We had a few questions regarding the format of a Delegation of Authority log. However, due to the lack of official form or further requirements outlined by the U.S. federal government, the format and content of the DOA log, as well as supporting SOPs, is flexible. When communicating with sponsors, provide copies of the organization’s SOP, DOA log template (if you create your own), and process for ensuring compliance to build confidence with the sponsor that you are in compliance with FDA and ICH.
