The National Institutes of Health (NIH) Policy on Good Clinical Practice (GCP) Training became effective January 1, 2017. This policy applies to NIH-funded investigators and site staff 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.
Available GCP training:
- 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 https://gcplearningcenter.niaid.nih.gov/).
- The Good Clinical Practice (GCP) course for Social & Behavioral Research is now available through the Collaborative Institutional Training Initiative (CITI Program). This course is presented in a dynamic, nine-module format with narration, interactive features, and downloadable resources. Please see the attachment for the steps to add the course to your current lesson plan.
- 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 Carrie Chiaro.
GCP training expires after three years.
If you have any questions, please contact one of the following institutional offices:
David Avery
TRI
214-2101
DAAVery@uams.edu
Edith Paal
IRB
686-5544
PaalEdithS@uams.edu
Darri Scalzo
Office of Research Compliance
686-8062
dlscalzo@uams.edu