NIH Studies Now Require Good Clinical Practice Training

NIH recently established a policy that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonization.  (See definition of “clinical trial” below.)

Effective Jan. 1, 2017, NIH requires institutions to develop an implementation plan to ensure compliance. The policy applies to all active grants and contracts, no matter what point they are in the life cycle of the trial.

The principles of 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 University of Georgia is establishing the process for ensuring all investigators and key study staff involved in an NIH-sponsored clinical trial or an FDA-regulated clinical trial complete GCP training.  GCP training may be accessed through the UGA CITI Portal (https://paul.ovpr.uga.edu/CITI/ ).  Instructions to enroll in the course and links to the NIH policy and FAQs can be found at http://research.uga.edu/hso/citi-training/ .

It is the Principal Investigator’s responsibility to ensure this responsibility is met by all key study personnel. GCP Training must be refreshed every three years.

The IRB will confirm compliance with this requirement at:

  • Initial Submission for new studies submitted on or after 03/01/2017.
  • Protocol revisions/modifications that involve a personnel change (i.e., personnel additions) submitted on or after 03/01/2017.
  • Continuing Review- at which time all research team members’ current CITI completion is assessed submitted on or after 03/01/2017.

NOTE: A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html.