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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.

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lisastein122

Answer:

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.

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