If it is conducting a clinical investigation under an investigational new drug application (IND), the clinical investigator and the sponsor must follow FDA regulations, including part 11.
This is important to bear in mind, even if a clinical investigation is run outside of US, but the clinical data will be part of a IND, then FDA regulations will apply. It is important to provide appropriate training to resources so that they are aware of applicable regulations depending on the nature and purpose of the study.