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.
There are several ways to complete GCP training:
GCP Courses for Biomedical Investigators and KSP
CITI offers a GCP Course as well as refresher courses at https://about.citiprogram.org/en/homepage/
NIDA/NIAID/Partners – MRCT Social and Behavioral GCP Training
If you would prefer to take NIDA, NIAID, Partners - MRCT, or Social and Behavioral GCP training, please follow the links below to do so.
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/\
- Partners - MRCT
GCP Training for Social and Behavioral Investigators and KSP
VUMC: Best Practices in Social and Behavioral Research for GCP via Learning Exchange
VU: Best Practices in Social and Behavior Research for GCP via Society of Behavioral Medicine website
NIH-Sponsored GCP Trainings
If, as a part of your NIH-sponsored work, they specify a course that will meet the GCP requirements of NIH, VUMC will also accept this training.
If you are unsure if the GCP training you plan to take will be accepted by VUMC, please contact email@example.com before you take the course so we can ensure you do not waste time taking a course that will not fulfill the training requirement.
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 the course you took offers a score report (specific scores on post-tests taken as a part of the course, please upload this to the REDCap survey. If the course you took only offers a completion certificate, you may upload this to the REDCap survey.
If you have any questions about this requirement please contact Research Support Services (322-7343 or firstname.lastname@example.org).
The REDCap database is set to send a reminder approximately 90 days prior to the expiration of your certificate. When you originally took your GCP course, if you had a Vanderbilt.edu address and this has since changed to a vumc.org address, you may not receive these reminder emails. You can let Research Support Services know about this change (email email@example.com), and they can update your email address.
Please note you will not be able to take the appropriate Refresher Course until 90 days prior to your training expiration date. Please wait until you are in this 90-day window to ensure you take the correct course.
When you are due for GCP training, that training can also fulfill your IRB annual training requirement for that calendar year only. You still need to complete the REDCap survey, and send your Completion Certificate to firstname.lastname@example.org to ensure both requirements are fulfilled. Please remember that course completion through CITI or the VUMC Learning Exchange are automatically emailed to VHRPP.