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The Role and Responsibilities of the Study Director in GLP Studies - PharmaFacts
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The Role and Responsibilities of the Study Director in GLP Studies

Guidances - OECD Guidances

The Study Director represents the single point of study control with ultimate responsibility for the overall scientific conduct of the study. This is the prime role of the Study Director, and all duties and responsibilities as outlined in the GLP Principles stem from it. Experience has shown that unless responsibility for the proper conduct of a study is assigned to one person, there is a potential for personnel to receive conflicting instructions, which can result in poor implementation of the study plan. There can be only one Study Director for a study at any given time. Although some of the duties of the Study Director can be delegated, as in the case of a subcontracted study, the ultimate responsibility of the Study Director as the single central point of control cannot.

In this regard, the Study Director serves to assure that the scientific, administrative and regulatory aspects of  the study are controlled. The Study Director accomplishes this by coordinating the inputs of management, scientific/technical staff and the Quality Assurance programme.

In multi-site studies which involve work at more than one test site and the Study Director cannot exercise  immediate supervision, study procedures may be  controlled by an appropriately trained, qualified and  experienced member of the staff, called the Principal  Investigator. He is responsible for the conduct of certain defined phases of the study in accordance with the applicable Principles of Good Laboratory Practice, acting on behalf of the Study Director. Scientifically, the Study Director is usually the scientist responsible for study plan design and approval, as well as overseeing data  collection, analysis and reporting. The Study Director is responsible for drawing the final overall conclusions from the study. As the lead scientist, the Study Director must
coordinate with other study scientists, and/or Principal Investigator(s) keeping informed of their findings during the study and receiving and evaluating their respective individual reports for inclusion in the final study report. Administratively, the Study Director must request and coordinate resources provided by management, such as personnel, equipment and facilities, to ensure they are adequate and available as scheduled for the proper conduct of the study.

Compliance with regulations is also the responsibility of the Study Director. In this role the Study Director is responsible for ensuring that the study is carried out in accordance with the Principles of GLP, which require the Study Director’s signature on the final study report to confirm compliance with the GLP Principles.

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