FDA does not have legal authority or jurisdiction outside

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Reference no: EM132197051

True or False with explanation:

1. Computerized Systems used in Clinical Investigations must follow the same FDA regulatory requirements that cover software in medical devices.

2. ICH and ISO have established Global Quality Standards, which can be applied to Outsourcing activities.

3. The provisions for “transfer of responsibilities” are the same for both drug and device clinical studies regulated by FDA.

4. All 21 CFR Part 312 and 812 regulations apply equally to both paper and electronic records.

5. The most common BIMO deficiencies cited at Clinical Investigator sites include: Inadequate Monitoring, Failure to secure investigator compliance, and Failure to obtain signed Investigator Agreement.

6. FDA does not have legal authority or jurisdiction outside of the United States and occupied territories.

Reference no: EM132197051

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