Who is responsible for the overall conduct of a GLP nonclinical study?

Who is responsible for the overall conduct of a GLP nonclinical study?

• A. Sponsor
• B. Quality Assurance Unit
• C. Study Director
• D. FDA Inspector

Answer: (C)

In GLP nonclinical studies, the person who oversees the entire conduct of the study and ensures it is carried out according to the protocol and GLP requirements is the Study Director. This role holds the accountability for study quality, data integrity, interpretation, and the final report. The sponsor may sponsor and fund the work and appoint the Study Director, but the responsibility for how the study is conducted rests with the Study Director, not the sponsor. The Quality Assurance Unit provides independent oversight to verify GLP compliance, perform audits, and ensure processes are followed, but does not conduct the study itself. An FDA inspector is a regulator who reviews the study and facilities; they are not responsible for directing the study’s conduct.

In GLP nonclinical studies, the person who oversees the entire conduct of the study and ensures it is carried out according to the protocol and GLP requirements is the Study Director. This role holds the accountability for study quality, data integrity, interpretation, and the final report. The sponsor may sponsor and fund the work and appoint the Study Director, but the responsibility for how the study is conducted rests with the Study Director, not the sponsor.

The Quality Assurance Unit provides independent oversight to verify GLP compliance, perform audits, and ensure processes are followed, but does not conduct the study itself. An FDA inspector is a regulator who reviews the study and facilities; they are not responsible for directing the study’s conduct.