FDA:研究者(investigator) 指实际实施临床研究的个人(即其直接指导下将研究药物施用于或配发给受试者)。如果研究项目是由团队执行,研究者则是研究团队的总负责者。“下级研究者(subinvestigator)”包括研究团队的所有其他成员。(Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. “Subinvestigator” includes any other individual member of that team.)
FDA: 申办者-研究者 一词通常是指学术机构中负责、发起和在单个地点进行临床研究(有时称为研究者发起的研究)的个人,因此符合申办者和研究者的定义 以及用于 IND 法规目的的研究者。(The term sponsor-investigator typically refers to an individual at an academic institution who takes responsibility for, initiates, and conducts a clinical investigation at a single site (sometimes referred to as an investigator-initiated study) and therefore meets the definition of both a sponsor and an investigator for purposes of the IND regulations.)