FDA Regulated Clinical Trials Protocol Template (available through MICHR)

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Protocol Template

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The University of Michigan has an approved Federalwide Assurance (FWA) with the U.S. Department of Health & Human Services (HHS). U-M’s IRBs are also registered with the HHS Office for Human Research Protections (OHRP).

U-M FWA Number: FWA00004969
U-M Institution/Organization Number: IORG0000144

Expiration dates for assurance changes regularly. If you need the expiration date, visit OHRP’s registration database, enter the FWA Number above, and click “Search.”

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