New GCP Training Requirements for Clinical Trials

Research Administration News New GCP Training Requirements for Clinical Trials

New GCP Training Requirements for Clinical Trials

The NIH recently announced a new policy regarding GCP training that takes effect January 1, 2017. The policy requires basic GCP training, then refresher GCP training every three years. The policy can be found at Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148.
 
All UAB investigators and staff involved in clinical trials, regardless of funding source, will be required to meet the new GCP training requirement. Current GCP training (taken within the past three years) will be required for new protocols submitted to the Office of the IRB as of January 1, 2017. Ongoing protocols must meet this requirement by February 28, 2017.
 
UAB has added a GCP refresher course to its CITI course offering list. The GCP course aligns with new NIH policy. Instructions to complete the basic and refresher GCP courses can be accessed via the UAB IRB website here.
 
What is GCP?
Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analyzing and reporting of clinical trials. Compliance with GCP provides assurance that the study data are credible and accurate and that the rights, safety, confidentiality and well-being of research participants are protected.
 
Who needs training?
GCP training is required for all UAB investigators and clinical trial staff involved in a clinical trial, regardless of funding source.
 
Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. For more information, see the NIH definition of clinical trial here.

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