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Good Clinical Practice

Last Updated: July 19, 2022 3:02:46 PM PDT
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Learn about the NIH's Good Clinical Practice requirement.

NIH issued a policy, effective January 1, 2017, establishing the requirement that all investigators and staff involved in the conduct, oversight, or management of NIH funded clinical trials must be trained in Good Clinical Practice (GCP).  

Policy Details

The principles of Good Clinical Practice (GCP) help assure the safety, integrity, and quality of clinical trials.  GCP provides a standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data), and outline the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors.  GCP addresses elements related to the design, conduct and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data) of clinical trials.

The study’s Principal Investigator is responsible for identifying staff that are required to take GCP training.  All responsible parties should complete their GCP training before their involvement in the clinical trial.  NIH requires that GCP training be renewed at least every 3 years.  

For additional information, please see the NIH policy (Notice Number NOT-OD-16-148) and FAQs.

Training Information & Resources

  1. Good Clinical Practice (GCP) Frequently Asked Questions (FAQs)
  2. Good Clinical Practices Factsheet
  3. "ALCOA": Elements of Good Documentation Factsheet
For additional information, please contact the Research Compliance and Integrity Office at (858) 822-4939, rci@ucsd.edu.