Good Clinical Practice (GCP) training pertains to the international ethical and scientific standard expected in design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
- Biomedical GCP training — hosted by citiprogram.org
- Social-behavioral GCP training — hosted for NIH by Society of Behavioral Medicine
Who must take GCP Training/ How often
Principle Investigators (PI)s and study staff* on studies meeting the NIH definition of a clinical trial must complete GCP training every three years.
Investigators who conduct social-behavioral clinical trials, may be required to take GCP training. USC IRBs will accept training certificates for the social-behavioral GCP course hosted for NIH by the Society of Behavioral Medicine
- USC GCP Training Mandate
- NIH Frequently asked Questions regarding GCP training requirement
- NIH GCP training policy
- NIH Definition of Clinical Trial Decision Tree
NIH Definition of “Clinical Trial”
A clinical trial is 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”.
*GCP training is required for study staff who collect data through intervention or interaction with a subject or have access to private identifiable information however, any member of a study team may be asked to take GCP training at the request of the IRB.