Question

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.

Answer 1

Answer:

The correct answer is - C.

Explanation:

Unanticipated problems can be explained as any incident or outcome that follows the following:

Unexpected result or incident in terms of nature, severity, or frequency, stander process and subject being studied. If the incident or problem may or definitely going to affect rights, safety or wellness. If there is any type of risk physiological, economical social harm.

Investigators must report all unanticipated problems and events to the IRB if it meets the criteria given above.

Thus, the correct answer is - C.