As stated in #4, the regulations require that sponsors select investigators who are
qualified by training and experience as appropriate experts to investigate the drug. The
regulations do not specify the minimum requirements nor do the regulations specify what
qualifications an investigator must have in order to be considered qualified by training
and experience to conduct a clinical investigation. Sponsors have discretion in
determining what qualifications, training, and experience will be needed, based on the
general recognition that this would include familiarity with human subject protection
(HSP) regulations (i.e., 21 CFR Parts 50 and 56) and practices as well as good clinical
practice (GCP) regulations (see 21 CFR Part 312) and standards (e.g., ICH E6) for the
conduct of clinical studies.
