Good Clinical Practice (GCP)

Good Clinical Practice is a set of Guidelines that must be followed when conducting clinical trials to ensure that the rights and well-being of the trial participants are protected and that the data generated in the trial is valid. The Blue Buffalo Veterinary Clinical Trials Office (BBVCTO) conducts all studies in the spirit of with “Good Clinical Practices” (GCP) unless they are for registrational purpose.

12 Golden Rules

 Investigators must:

  1. Have appropriate qualifications and time for the study
  2. Know and follow the study protocol
  3. Provide sufficient qualified and capable study personnel
  4. Carefully select suitable patients
  5. Obtain informed consent and protect animals’ welfare
  6. Ensure study facilities and equipment are adequate
  7. Record all data carefully
  8. Meticulously Document product accountability
  9. Collect and record adverse events and changes in animal health
  10. Ensure the appropriate handling of study laboratory specimens
  11. Maximize data quality
  12. Maintain good trial files and perform study conclusion tasks

To download the FDA guidelines document click here.

The new NIH policy issued on September 16, 2016 (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) stating that NIH-funded investigators and staff should be trained in GCP. This policy takes effect January 1, 2017. 

The policy applies to all NIH-funded investigators and staff “who are involved in the conduct, oversight, or management of clinical trials” and states that the personnel “should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).”

The basic and refresher GCP and ICH CITI courses can be accessed via the Office of Responsible Research Practices (ORRP) website.