In the early GLP preambles, some items were moved from one role to another to balance responsibility. From which role to which role were they moved?

• A. Study director to management
• B. Management to study director
• C. Quality assurance to management
• D. Study director to compliance officer

Answer: (A)

Balancing responsibility is a core idea in GLP: the person directing the study handles scientific conduct and data integrity, while management oversees resources, policies, and overall compliance. In the early GLP preambles, some duties that used to sit with the Study Director were moved to Management to share accountability and ensure there’s proper oversight beyond the scientific lead. This shift helps prevent a single role from bearing too much authority and strengthens governance over the study as a whole, with management providing the necessary support and oversight that underpins good laboratory practice.

This approach makes sense because it aligns with the goal of clear, distributed responsibility. Moving those items to Management keeps the Study Director focused on the scientific aspects while ensuring resource decisions, training, and policy compliance are monitored at an organizational level. Choices that would shift responsibility to QA, compliance, or back to the Study Director would either undermine independent oversight or overburden the study lead, respectively.