Study Director, Qualifications, and Responsibilities

The study director represents the central point of control with ultimate responsibility for the overall conduct of the study. This is the prime role of the study director, and all responsibilities as outlined in GLP principles stem from it.6 The study director accomplishes this by coordinating inputs of management, scientific/technical staff, and the QA program. 

Responsibilities The study director is usually the scientist responsible for study plan design and approval, as well as overseeing data collection, analysis, 

Interface with the Study The phrase, responsibility for the overall conduct of the study and for its report may be interpreted in a broad sense for those studies where the study director may be geographically remote from actual experimental work. With multiple levels of management, study personnel, and QA staff, it is critical that there are clear lines of authority and communication, and assigned responsibilities, so that the study director can effectively carry out GLP responsibilities. This should be documented in writing. 

For studies that have delegated responsibilities to a PI, the study director will rely on that individual to ensure that relevant phase)s) of the study are conducted in accordance with the study plan, relevant SOP, and principles of GLP. The PI should contact the study director when event(s) occur that may affect the objectives defined in the study plan. All communications should be documented. Communication between the study director and the QA is required at different stages of the study. For instance (1) to review study plans (2) to review new and revised SOPs (3) attendance of QA personnel at study initiation meetings and in resolving potential problems related to GLP (4) by responding to inspection and audit reports promptly (5) by indicating corrective action and (6) by necessary liaison with QA staff, and scientific and technical personnel. In certain unforeseen conditions, change of study director becomes essential. Under such conditions, replacement of the study director should take immediate effect. 

Replacement Because the study director has responsibility for the overall conduct of a study according to the GLP principles, he or she must ascertain that every phase of a study fully complies with these principles, that the study plan is followed faithfully, and that all observations are fully documented. Theoretically, this responsibility can only be fulfilled if the study director is present during the whole study. This is not always feasible in practice, and there will be periods when replacement may be necessary. Although the circumstances under which a study director would be replaced are not defined in GLP principles, they should be addressed by the facility SOPs. These SOPs also should address procedures and documentation necessary to replace a study director. 

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