FDA's regulations are not explicit

FDA's regulations are not explicit as to what comprises adequate training for study staff (e.g., GCP training) or how often training should be completed. Instead, FDA's regulations broadly require that clinical investigators be qualified by education, training, and experience to perform their assigned duties. Sponsors must choose qualified investigators and sponsors have discretion in determining what qualifications will beneeded, based on the general recognition that this would include education, training, and experience pertinent to the particular clinical study and its design and execution, as well as familiarity with human subject protection (HSP) regulations, and recordkeeping, data integrity, and GCP standards and requirements