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Study Protocol and Study Conduct

The study director will prepare a written protocol that meets GLP and Texas A&M requirements. The GLP study protocol will be audited by the Texas A&M QAU to ensure that the protocol meets the GLP requirements. Prior to study initiation the protocol must be reviewed and signed by the sponsor. Unless otherwise agreed in advance, Texas A&M will retain the original (signed) protocol, amendments, and deviations, and exact copies will be submitted to the QAU and the sponsor upon request. The study director will ensure that a copy of the study protocol and any subsequent amendments are submitted to each sub-contract site (as applicable).

Each GLP study must have an IACUC approved AUP. The information contained in the AUP must correlate with the contents of the study protocol. During the conduct of GLP studies, any determination of differences between SOPs and the study protocol will be resolved on the basis that the approved study protocol supersedes SOPs.

A Texas A&M protocol template may be utilized for writing the GLP study protocol. The Texas A&M template may be modified to suit individual GLP studies, but in no case will required elements be omitted. The sponsor may prefer to use a different template for the protocol in which case the Texas A&M QAU will audit the template to ensure that it adheres to Texas A&M requirements. (Refer to Texas A&M Protocol SOP)

GLP protocols must contain the following information at a minimum:

  1. A descriptive title and statement of purpose
  2. Identification of the test and control articles by name, chemical abstract number, or code number
  3. The name of the sponsor and the name and address of the testing facility
  4. The name and addresses of any sub-contract sites (including the sponsor site) where study activities will be performed
  5. The number, body weight range, sex, source of supply, species, strain, sub-strain, and age of the test system
  6. The procedure for identification of the test system
  7. A description of the experimental design, including methods for the control of bias
  8. A description and/or identification of the diet to be used as well as solvents, emulsifiers, and/or materials used to solubilize or suspend the test or control articles before mixing with the carrier. The description will include specifications for acceptable levels of contaminants that are reasonably expected to be present in the diet and/or are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications.
  9. The type and frequency of tests, analyses, and measurements to be made
  10. A description of the necropsy procedure, tissue collection, histological processing, and histopathological analyses to be performed
  11. Instructions for handling moribund or terminal animals prior to study completion
  12. The records to be maintained and the retention location
  13. The dated signatures of the study director and the sponsor
  14. A statement of the proposed statistical methods to be used and acceptable levels of statistical significance to be accepted
  15. Specify responsibility for performance of characterization of test and control articles including appropriate testing for identity, strength, purity, composition or other characteristics for each batch or lot and methods of synthesis, fabrication, or derivation of the test and control articles and stability testing as applicable
  16. If the study is conducted at multiple sites the location of the lead QAU will be included along with the names of principal investigators and/or contributing scientists. A flowchart, table, or narrative description of the roles and responsibilities and flow of communication for each site.
  17. When Texas A&M is the only testing facility, the protocol will include a description of responsibilities of the sponsor.
  18. Specify that reserve samples of each batch or lot of test and control articles will be retained for studies longer than 4 weeks in duration and the location where reserve samples will be retained
  19. The location where raw data and specimens will be retained including residual tissues not used for histological analyses
  20. A regulatory compliance section stating the GLP status of the study and any other federal or international regulations (including USDA regulations), consensus documents, and guidance documents that must be adhered to.
  21. Define reporting requirements (e.g., interim reports and contributing scientists reports)
  22. Method for documenting deviations and amendments to the study protocol

Amendments to GLP study protocols will be promptly prepared. Amendments must be approved by the study sponsor and exact copies provided to the QAU (See also IACUC section). Personnel providing support services for GLP studies will review study protocols prior to study initiation and amendments prior to performing activities associated with the amendment. The reviews will be documented. Deviations to protocols and SOPs will be documented with justification. Prior approval for deviations to the study protocol must be obtained from the study director whenever feasible. When prior approval is not possible, the study director will be promptly notified of deviations.