FDA’s regulation at 21 CFR 312.3(b) states: “In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. ‘Sub Investigator’ includes any other individual member of that team”. 21 CFR 312.53(c)(1)(viii) requires the investigator to provide “a list of the names of the sub investigators (e.g., research fellows, residents) who will be assisting the investigator in the conduct of the investigation(s)”.
The purpose of Section #6 is to capture information about individuals who, as part of an investigative team, will assist the investigator and make a direct and significant contribution to the data. The decision to list an individual in Section #6 depends on his/her level of responsibility (i.e., whether he/she is performing significant clinical investigation-related duties). In general, if an individual is directly involved in the performance of procedures required by the protocol, and the collection of data, that person should be listed on the 1572. For example, if the protocol notes that each subject needs to visit a specified internist who will perform a full physical to qualify subjects for the clinical investigation, that internist should be listed in Section #6.