Neither FDA's regulations nor guida

Neither FDA's regulations nor guidance provide specific guidelines on how often GCP training should be completed by principal and sub-investigators and study staff involved in investigational drug research or how the training should be documented. The regulations require that sponsors choose investigators qualified by training and experience (see 21 CFR 312.53(a)). The regulations also require that investigators commit themselves to personally conduct or supervise the investigation (see 21 CFR 312.53(c)(1)(vi)(c)).