If a non-U.S. site 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. If required records (e.g., drug disposition, case report forms, case
Histories) are kept in electronic format, part 11 requirements will apply (see section III).
Device clinical investigations conducted at non-U.S sites generally are not conducted
under an investigational device exemption (IDE). However, in the event where non-U.S.
clinical investigation sites agree to comply with 21 CFR part 812, for example, per the
requirements outlined in the study protocol or in the investigator agreement, then the
clinical investigator and the sponsor should follow FDA regulations, including part 11.
For foreign clinical studies not conducted under an IND or an IDE that are submitted to
FDA in support of a research or marketing application, good clinical practice standard for
electronic records and electronic systems would apply.22
