Effective Date: January 1, 2017

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 trials¹ complete Good Clinical Practice (GCP) training by January 1, 2017. 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, which is required by the IRB. Some specifics about the policy:

• Current options to meet the GCP training requirement:
  • CITI Program – select Good Clinical Practice (GCP) modules
  • NIH's NIAID GCP Learning Center
• This Policy applies to investigators and clinical trial staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials.
• For new NIH-funded clinical trials, you must provide documentation of training completion as part of the Just-in-Time process. It is not yet clear how NIH will implement this requirement for ongoing awards.
• Check your current training records here (select GCP from training type menu).

If you have further questions regarding this requirement, please contact the Office of Clinical Trials at This email address is being protected from spambots. You need JavaScript enabled to view it. or 919.843.2698. Please note: the completion of the initial GCP training is effective for 3 years. At the end of a 3 year period, a refresher course will be required.

¹ 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.