Does FDA expect sponsors, clinical investigators, study personnel, and study participants to be trained on the use of a specific mobile technology if the technology is used in a clinical investigation?

Yes. Sponsors, clinical investigators, study personnel, and study participants must be
adequately trained on the use of any mobile technology they will use in a clinical
investigation (see 21 CFR 11.10(i)). Training should occur before the use of the mobile
technology and whenever changes are made (e.g., software or system upgrades) to the
mobile technology during the course of the clinical investigation. In addition, clinical
investigators and study personnel should periodically reassess and retrain study
participants, as necessary, on systems that are more complex or that pose a higher risk to
the conduct of the study.