In GLP, who is primarily responsible for ensuring that a study is conducted according to the protocol and SOPs?

• A. Study Director
• B. QA Auditor
• C. Laboratory Technician
• D. Principal Investigator

Answer: (A)

In GLP, the person who is responsible for making sure a study is conducted according to the protocol and SOPs is the Study Director. This role is the anchor for the study’s integrity, overseeing the entire conduct of the study, approving the protocol and SOPs to be followed, training personnel, and ensuring that deviations are properly documented and justified. The Study Director signs off on the study report and holds the ultimate accountability for whether the study was performed in compliance with GLP requirements, the protocol, and approved SOPs.

The QA Auditor’s job is to provide independent quality assurance by auditing activities and confirming compliance, but they do not carry the primary responsibility for day-to-day adherence. The Laboratory Technician carries out tasks as instructed, but accountability for compliance rests with the Study Director. The Principal Investigator may oversee the scientific aspects in some settings, but GLP assigns the overarching responsibility to the Study Director to ensure uniform adherence to protocol and SOPs across the study.