483
Women & Infants Hospital IRBFDA 483 - Women & Infants Hospital IRB - January 11, 2017
Record Details
An FDA inspection of Women and Infants Institutional Review Board in Providence, RI, revealed two significant issues. The IRB failed to maintain sufficiently detailed meeting minutes and did not conduct continuing review of research at appropriate intervals based on risk. These observations indicate deficiencies in the IRB's oversight and record-keeping practices.
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ID · 2549a252-a037-443e-b5a0-9fd0e7943c48