Good Laboratory Practice (GLP) regulations require the appointment of a Study Director by Test Facility Management for each study.
By virtue of the legal status of the Study Director in testifying to the performance, compliance, accuracy and integrity of the conduct of the study, its data and the final report, the role of the GLP Study Director is critical to study integrity and regulatory compliance and potentially the most complex.
This guidance is intended to be read in conjunction with the Organisation for Economic Co-operation and Development (OECD) Series on Principles of GLP and Compliance Monitoring Number 8 (Revised) Consensus Document, “The role and responsibilities of the Study Director in GLP studies
The booklet addresses both the Regulatory role of the Study Director, whilst also addressing matters potentially affecting Study Director’s that are not defined by GLP regulation or guidance, but may be imposed by the role and position of the Study Director within a commercial organisation.
2. OECD GLP definition of a Study Director
3. The single point of control
4. Appointment of the Study Director
5. Qualifications and training of the Study Director
7. Replacement of the Study Director
8. Responsibilities of the Study Director as defined by OECD GLPs
9. Study planning
10. Multi-site studies
11. Study oversight
12. Quality control
13. Reporting of the study
15. Managing relationships with others