An investigational biologic administered to the first two subjects in a Phase II clinical trial was not appropriately screened for two viral contaminants, HIV and Hepatitis B, due to human error in the screening process. Follow-up testing indicated that the subjects and their partners were not infected. The subjects and others were notified of the increased risk. A. There was no need to inform the IRB because this was a screening procedure.
B. This is an adverse event, which is also an unanticipated problem.
C. This is an unanticipated problem requiring notification to the IRB and FDA.
D. This is neither an unanticipated problem, nor an adverse event.