The principles of Good Clinical Practice (GCP) training, consistent with the International Conference on Harmonisation (ICH) Efficacy Document E6, help to ensure the safety, integrity, and quality of clinical trials.
Per NIH’s Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials, everyone involved in the design, conduct, oversight, or management of an NIH-funded clinical trial (e.g., the study principal investigator/chair, coordinators, statisticians, data managers, clinicians, and nurses) must receive GCP training. GCP training should be refreshed at least every 3 years. Proof of training is to be retained and provided upon request.
GCP training may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization.
Acceptable GCP courses include: