GCP Training

 

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 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 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 or GCP – Social and Behavioral Research Best Practices for Clinical Research. CITI Social-Behavorial GCP Training
• Complete NIH-developed GCP training at https://gcplearningcenter.niaid.nih.gov/Pages/default.aspx or at https://gcp.nidatraining.org/about. Send completion certificate to Kimberly Givens  in the Office of Research Compliance ( KGivens@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 Kimberly Givens (KGivens@uams.edu)

*GCP training expires after 3 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:

• Amy Jo Jenkins
  TRI
  686-5939
  AJJenkins@uams.edu

• Darri Scalzo
  Office of Research Compliance
  686-8062
  DLScalzo@uams.edu

• Jennifer Holland
  IRB
  526-7559
  JRHolland@uams.edu

• Larry Cornett, PhD
  Office of the Vice Chancellor of Research
  686-5347
  CornettLawrenceE@uams.edu