483
Santa Clara Valley Medical Center IRBFDA 483 - Santa Clara Valley Medical Center IRB - June 03, 2021
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Record Details
An FDA inspection of Santa Clara Valley Medical Center IRB in San Jose, CA, revealed two significant issues. The IRB failed to ensure that research, other than expedited reviews, consistently received approval from a majority of members present. Additionally, the facility did not properly maintain a comprehensive list of its IRB members, lacking crucial details for several individuals.
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ID · 1175d894-c67c-4060-90ea-9d7535555d69