Study Director

The study director is the single point of contact for study control and is granted authority by Texas A&M testing facility management to oversee their respective GLP studies in accordance with the regulations and Texas A&M requirements (refer to Texas A&M SOP for Study Directors for details). The Study Director must be a scientist or other professional of appropriate education, training, and experience, or a combination thereof as determined by testing facility management based on documented evidence of qualifications. Study Directors must have documented training on the GLP regulations.

A Study Director may be either an employee of Texas A&M or may be provided by the sponsor. Study Directors employed by Texas A&M are appointed by testing facility management and approved by the sponsor. If the study director is not an employee of Texas A&M he/she must be approved by Texas A&M testing facility management and the sponsor. Study director appointment will be documented in writing by testing facility management. In the event a study director must be replaced, testing facility management will appoint a qualified replacement and the sponsor will approve the appointment. In the interim, testing facility management will appoint an “acting” study director until a permanent replacement is appointed.

When only a part of GLP study services (e.g., pathology, histology, histomorphometry) are provided by Texas A&M, study director appointment is the responsibility of the sponsor and primary testing facility.

Study directors will:

1. Oversee all study activities in accordance with GLP regulations and abide by animal care and use regulations and Texas A&M procedures and policies.
2. Ensure that mechanisms exist to manage study activities at other test sites (as applicable).
3. Authorize deviations to the protocol and prepare protocol amendments as necessary.
4. Serve as the single point of control for the study. Communicate critical information to key study personnel at Texas A&M, other test sites, the sponsor, and to contributing scientists as applicable.
5. Respond to QA noncompliance findings and ensure corrective actions are implemented in a timely manner to minimize impact on GLP study data.
6. Work cooperatively with the attending veterinarian to ensure compliance with the Animal Welfare Act and Texas A&M Institutional Animal Care and Use policies and procedures.