December 21st, 2016

New NIH policy has been released, requiring clinical investigators and clinical research staff to be trained in Good Clinical Practice (GCP) in order to receive NIH funding. This requirement is effective on January 1, 2017.

Effective January 1, 2017, the University of Utah IRB requires clinical investigators and staff listed on an IRB application funded by the NIH to have both human subjects training and GCP training before an IRB application will be approved. For currently approved and active studies, the IRB will require both trainings be completed at the next continuing review. Investigators and staff are encouraged to complete GCP training early to avoid delays in IRB approval.  GCP training must be recertified every 5 years to meet IRB requirements.

GCP training does not replace the standard human subject research training required by the IRB. For clinical investigators and staff receiving NIH funding, human subjects training, such as the CITI biomedical research module, and GCP training are both required.

To assist University of Utah clinical investigators and staff members in meeting this requirement, the following resources are available:

• An online GCP training module is available through the CITI Program for University of Utah investigators and staff. To access this module, follow the instructions available at the IRB Training page.
• The Research Administration Training Series (RATS) offers an in-person and online course titled, Basics of Good Clinical Practice, which is available to University of Utah investigators and staff. To register for the in-person course, visit the Basics of Good Clinical Practice class. To register for the online course, visit the Research Education Online Classes page.
• Many GCP training options are offered beyond the CITI GCP module and the RATS program. Such training options will be accepted by the IRB, so long as the training program covers all of ICH E6 and issues a training completion certificate.
• ERICA now has the capacity to track GCP training. For those who complete the training, ERICA will display a ‘G’ next to the names of investigators and staff listed on the Contacts and Title page of an IRB application. GCP training completion certificates must be sent to irb@hsc.utah.edu to be tracked in ERICA.