Hospital staff, including nurses, residents, or fellows and office staff 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. It is not necessary to include in this section a person with only an occasional role in the conduct of the research, e.g., an on-call physician who temporarily dealt with a possible adverse effect or a temporary substitute for any research staff (see ICH E3, Section 6)Concerning staff residents on rotation, it may be difficult to prospectively identify those individuals who might perform specified protocol procedures or collect clinical data. Specific names of the rotational staff do not have to be listed in Section #6. Instead, to successfully address this scenario, the names of rotational individuals and the procedures they are expected to perform should be included in the clinical study records. This information should also be sent to the sponsor for submission to FDA in, for example, an information amendment.
