The NIH Policy on Good Clinical Practice (GCP) Training became effective January 1, 2017. This policy applies to NIH-funded investigators and site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials. An NIH Clinical Trial is defined as Research studies in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.
If you are conducting an NIH-funded clinical trial, you will need to complete your training as soon as possible. There are several ways to do this:
Complete GCP training using the CITI program at https://www.citiprogram.org/. Log in using the user ID and password that you used for your human subjects protection training, scroll down past the list of courses you have completed and select Add a Course. Select Good Clinical Practice (GCP) Basic Course.
Complete NIH-developed GCP training. Send completion certificate to Catrice Banks-Johnson in the Office of Research Compliance (CRBanksjohnson@uams.edu).
For social and behavioral researchers, you can log onto Blackboard and complete the NCATS-developed GCP training. View documents for the GoSignMeUp registration process and basic navigation functions for the Blackboard Course. A Certification of Completion will be generated upon the conclusion of the final module. Send completion certificate to Catrice Banks-Johnson in the Office of Research Compliance (CRBanksjohnson@uams.edu).
Send record/certificate of current GCP training (i.e., from industry-sponsored trial participation, from ACRP or SoCRA certification, or from completion of UAMS Graduate School courses PHSC6043 or PGSP6101) to Catrice Banks-Johnson (CRBanksjohnson@uams.edu).
For options 2-4 above, Catrice will record this training in Training Tracker for you upon receipt of your completion certificate.
NOTE: GCP training expires after three years.
If you have ambitions of conducting an NIH-funded clinical trial, you are highly encouraged to complete the training now!
Even if you have determined this does not apply to you, you are highly encouraged to complete the training now! GCP training is likely to be mandated within the next 6-12 months, as many institutions, journals, and other funding sources are trending toward this requirement.
The UAMS Office of Research Compliance will conduct random audits to ensure compliance with this policy.
If you have any questions, please contact one of the following institutional offices: