Good Clinical Practice (GCP) Training
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.
USC offers GCP training online through www.citiprogram.org
Who must take GCP Training
Good Clinical Practice (GCP) training is required for study Principle Investigators (PI)s and personnel conducting conducting clinical trials. The requirement applies to clinical trials at all levels of IRB review.
PIs and staff on new studies and any new staff on ongoing studies meeting the NIH definition of a clinical trial must complete GCP training.
- 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 intended 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.
GCP Course Content
There are two GCP course tracks provided at www.citiprogam.org
GCP for Clinical Trials with Investigational Drugs and Biologics
GCP for Clinical Trials with Investigational Medical Devices