GCP Training Required for NIH-Sponsored Clinical Trials

December 16, 2016

The National Institutes of Heath (NIH) policy on Good Clinical Practice (GCP) training takes effect January 1, 2017

This policy establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).

Does this apply to my study?

If you are conducting a "clinical trial", then the answer is YES.  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.

Who needs to take the training?

According to the policy, all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials:

Investigator:  The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. 

Clinical trial staff:  Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

How do I access this training?

NIH is making Good Clinical Practice training modules specific to social and behavioral research available for download.  You can find the modules here: https://obssr.od.nih.gov/training/web-based-learning/good-clinical-practice-for-social-and-behavioral-research-elearning-course/

Please also know that CUHS staff will let you know if GCP training is needed during the review process of your IRB submission. 


Please contact the CUHS office at (617) 496-2847 or by email at cuhs@fas.harvard.edu