483
Rush University Medical Center IRBFDA 483 - Rush University Medical Center IRB - April 02, 2010
Record Details
An FDA inspection of Rush University Medical Center IRB in Chicago revealed three significant issues. The IRB failed to ensure a study involving children complied with specific regulations for pediatric clinical investigations, which was a repeat observation. Additionally, the IRB lacked written procedures for determining significant versus non-significant risk devices and did not properly advise members of research proposals approved via expedited review.
- Office
- Chicago District Office
- Person
Open in Dashboard
ID · 7cdbe04b-dfbf-4be9-8020-2720c60695c5