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.
This is an unexpected problem that has occurred during the screening process.
Explanation:
Due to the error during screening, the required course of action would be to notify the FDA as well as other regulatory and ethics committees involved.
