NIH has issued a policy on Good Clinical Practice training for NIH Awardees involved in NIH-funded clinical trials. This policy requires that PIs and clinical trial staff involved in all new and ongoing NIH-defined clinical trials complete Good Clinical Practice (GCP) training. GCP principles help assure the safety, integrity, and quality of clinical trials by addressing elements related to trial design, conduct, and reporting. GCP training is in addition to, and different from, Human Subject Protection training required by the IRB.

• UNC offers GCP training through CITI (Collaborative Institutional Training Initiative) with an option to take a social and behavioral research course or an investigational drugs, biologics and devices course.
• For more information on UNC's GCP training requirements, see research.unc.edu/human-research-ethics/getting-started/training