483
Children's National Medical Center IRBFDA 483 - Children's National Medical Center IRB - May 20, 2025
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The FDA inspected Children's National Medical Center IRB in Washington, DC, from May 12-20, 2025. The inspection revealed that the IRB did not ensure informed consent documents contained all necessary elements, specifically the required clinicaltrials.gov statement for a pediatric study. This indicates a deficiency in the IRB's oversight of clinical trial protocols.
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ID · 8a612a73-287b-4027-ae47-dff51ceb39a2