To provide a single point of control during the conduct of each nonclinical study, FDA mandated:

• A. The position of study director
• B. A committee of three co-directors
• C. A QA auditor only
• D. A regulatory affairs liaison

Answer: (A)

The key idea is that one person must have overall responsibility for guiding the study to ensure integrity and compliance. In nonclinical GLP studies, the study director is designated to hold that single point of control, bearing responsibility for the conduct of the study, adherence to the protocol, proper data collection and documentation, and compliance with GLP requirements. This role also has the authority to resolve deviations and to sign off on the study report, providing a clear line of accountability.

A committee of co-directors would dilute accountability and slow decision-making, making it harder to enforce consistency. A QA auditor plays a critical monitoring and verification role but isn’t the one who directs day-to-day operations. A regulatory affairs liaison handles regulatory communications and submissions rather than controlling the conduct of the study itself.