Beginning January 1, 2017 the Vanderbilt Human Research Protection Program, in collaboration with Research Support Services, will begin a concerted effort to assist all investigators and key study personnel who are involved in NIH sponsored clinical trials to come into compliance with new NIH rules regarding completion of Good Clinical Practice (GCP) training.
GCP training must be completed every 3 years for anyone who is involved in the conduct, oversight, or management of clinical trials.
NOTE: GCP training will count as human subjects training for the purposes of IRB applications however, it does not change the requirement of annual human subjects training.
There are several ways to complete GCP training:
GCP Courses for Bio-Medical Investigators and KSP
CITI offers a GCP Course as well as refresher courses at https://about.citiprogram.org/en/homepage/
NIAID offers a self-paced 14 module course at https://learningcenter.niaid.nih.gov/
NIDA offers a self-paced 12 module course at https://gcp.nidatraining.org/
GCP Training for Social and Behavioral Investigators and KSP
VUMC Best Practices in Social and Behavioral Research for GCP
The Society of Behavioral Medicine Best Practices in Social and Behavioral Research course at https://www.sbm.org/training/good-clinical-practice-for-social-and-behavioral-research-elearning-course
Once you finish the training, please document it by completing this REDCap Survey.
Many of you may have already completed GCP training. If you completed it in the last three years, please document it by completing this REDCap Survey.
GCP training is expected to be renewed every three years and reminders will be forwarded in a timely fashion.
Moving forward, after March 31, 2017, all key study personnel on new IRB applications and continuing review requests must have completed GCP training. Additions of new personnel to an approved protocol will also require GCP training. Projects on which there are investigators or other key study personnel who have not completed GCP training in the last three years will not be accepted.
If you have any questions about this new requirement please contact Research Support Services (322-7343 or firstname.lastname@example.org).