NIH Required Training For Investigators Conducting Clinical Trials

The NIH has issued a policy requiring all NIH-funded investigators and their research staff who are involved in the conduct of clinical trials, as defined by the NIH, to complete Good Clinical Practice (“GCP”) training. This policy is effective January 1, 2017, and applies to both new applications, and on-going programs. The NIH definition of a clinical trial is “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.” This definition encompasses trials that do not involve drugs or devices, and investigators should review the NIH definition for more detail: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html

Although GCP training is typically associated with FDA regulated drug or device studies, the training requirement also applies to NIH funded studies that are only studying behavioral interventions. In addition, all members of the research team who may be engaged in the research must complete the training.

In order to comply with the NIH GCP training requirement, JHU investigators and their research staff who may be subject to this NIH requirement should complete the CITI GCP training module, which is available through mylearning, or may demonstrate compliance through providing a certificate of other acceptable GCP training to ORA and/or the JHM IRB.