Can the study director be the chief executive of a nonclinical laboratory?
No. The GLPs require that there be a separation of function between the study director and the QAU director. In the example, the QAU director would be reporting to the study director. Section 58.33 Study director. The GLPs permit the designation of an “acting” or “deputy” study director to be responsible for a study when the study director is on leave. Should study records identify the designated “deputy” or “acting” study director? Yes. • Is the study director responsible for adherence to the GLPs? Yes. Section 58.35 Quality Assurance Unit. As a QAU person, I have no expertise in the field of pathology. How do I audit pathology findings? The QAU is not expected to perform a scientific evaluation of a study or to “second-guess” the scientific procedures that are used. QAU inspections are made to ensure that the GLPs, SOPs and protocols are being followed and that the data summarized in the final report accurately reflect the results of the study. A variety of procedures can be used to
