The NIH Policy on Good Clinical Practice (GCP) Training became effective Jan. 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 currently 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 Good Clinical Practice 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 or GCP – Social and Behavioral Research Best Practices for Clinical Research. CITI Social-Behavorial GCP Training
- Complete NIH-developed Good Clinical Practice training at https://gcplearningcenter.niaid.nih.gov/Pages/default.aspx or at https://gcp.nidatraining.org/about.
- Industry sponsors may also provide Good Clinical Practice training to study staff.
Good Clinical Practice 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! Good Clinical Practice 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: