The regulations require sponsors to select a qualified (by training and experience) investigator who is considered an expert to investigate the drug. There are no minimum requirements or qualifications defined by the regulations. The sponsors can determine what qualifications, training, and experience will be needed in order to conduct the investigation. Familiarity with human subject protection (HSP) regulations (i.e. 21 CFR part 50 and 56) and good clinical practices (GCP) regulations (21 CFR 312) and standards (e.g. ICH E6) are among the necessary qualifications to conduct clinical studies.
