483
National Cancer Institute (NCI)National Cancer Institute (NCI) – FDA 483, Nov 15, 2016
Record Details
An FDA inspection of the National Cancer Institute (NCI) in Rockville, MD, identified a significant failure in their role as a clinical trial sponsor. The inspection revealed that NCI did not properly monitor a study or ensure adherence to the protocol, specifically regarding the timely reporting of serious adverse events. This indicates a lapse in oversight for clinical trial conduct.
View Company Profile
ID · 6147d136-d50e-46bd-a9e1-7e7869a30f56
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.