Good Clinical Practice Training

Good Clinical Practice Training (GCP) is critical to conducting research of the highest ethical standards and scientific quality. Most industry sponsored research requires this training for faculty and staff prior to initiating trials.

Face-to-Face GCP Training

To assist with completion of this training, YCCI offers Face to Face GCP training (initial and refresher) twice a year for faculty and staff. These have been conducted by independent consultants, Brian Bennett of GCP Training Live, and Michael Hamrell, PhD of CfPIE, and MORIAH Consultants. Each have met the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by Transcelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. Since the inception of these Face-to-Face sessions over 700 faculty and employees have been trained.

On Line CITI Training

In addition, the following online GCP training modules from the Collaborative Institutional Training Initiative (CITI) are available:

  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA focus) is suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum. This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by Transcelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) is suitable for individuals involved in clinical trials of drugs and biologics when the research may be international or where the individuals would prefer a more ICH-focused curriculum. This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by Transcelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) Refresher is meant to reinforce the importance of concepts covered in the basic level ICH focus course. This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by Transcelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.