# FDA 483 - Children's National Medical Center IRB - May 20, 2025

Source: https://www.globalkeysolutions.net/records/483/childrens-national-medical-center-irb/8a612a73-287b-4027-ae47-dff51ceb39a2

> FDA 483 for Children's National Medical Center IRB on May 20, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Children's National Medical Center IRB
- Inspection Date: 2025-05-20
- Product Type: other
- Office Name: Baltimore District Office
- Summary: 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.

## Related Documents

- [483 - 2019-06-06](https://www.globalkeysolutions.net/records/483/childrens-national-medical-center-irb/cd660198-2ab9-4959-a546-d2515ce955b9)
- [483 - 2019-06-06](https://www.globalkeysolutions.net/records/483/childrens-national-medical-center-irb/c3864a46-56f0-4bd6-b51c-502cb15b2a6c)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/brittany-l-carpenter/600db4d0-0b6b-435f-b511-2ca10f292d5d)

Company: https://www.globalkeysolutions.net/companies/childrens-national-medical-center-irb/b85c818b-4db6-4f98-a73b-5ba95b927999

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa