What is a unique OECD GLP requirement for a study director?

• A. To ensure that computerised systems used in the study have been validated
• B. To approve the study's final report
• C. To manage the facility's budget
• D. To perform all experimental procedures

Answer: (A)

In GLP, the study director’s role centers on ensuring the study is conducted in a compliant, reliable way, with data integrity at the forefront. A key, often highlighted requirement is that any computerised systems used to manage, capture, analyse, or report study data must be validated for their intended use. Validation provides documented evidence that the system does what it is supposed to do, consistently and accurately, across the study’s lifecycle. This includes establishing that the software and hardware can reliably produce traceable, auditable results, with proper access controls, data backup, and integrity checks. Because the study director bears ultimate responsibility for the study’s conduct and outcomes, confirming that these systems are validated is a direct and essential part of fulfilling that role.

Other options aren’t as central to the study director’s unique responsibilities: approving the final report is important but involves broader quality assurance and sponsor processes; managing the facility’s budget isn’t a GLP-specific duty; performing all experimental procedures isn’t required, since GLP emphasizes proper oversight and compliance rather than sole hands-on execution.