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.

Action Required: Attention NIH and Industry Investigators- New GCP Training Policy

The National Institutes of Health (NIH) have issued a new training policy: “Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148.” Yale University, in compliance with this policy, is requiring investigators and clinical trial site staff who are responsible for the conduct, management, and oversight of NIH-funded as well as industry-sponsored clinical trials to be trained in Good Clinical Practice (GCP). According to the new policy, a GCP refresher course will be required every three years. This policy is effective as of January 1, 2017. The Yale Human Research Protection Program (HRPP) will require investigators and research staff to comply with this policy.

If you have not been trained in GCP or have not completed a refresher course in the past three years, you must complete one of the courses listed below by January 1, 2017.

• CITI GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)*
• CITI Good Clinical Practice Course (US FDA focus)*
• CITI GCP FDA Refresher *
• CITI GCP ICH Refresher*
• NIAID GCP Learning Center Course
• National Drug Abuse Treatment Clinical Trials Network Good Clinical Practice Course
• Industry Sponsor GCP Training offered by TransCelerate Member Companies*. For more information, please visit https://www.transceleratebiopharmainc.com/gcp-training-attestation/
• Yale Center for Clinical Investigation (YCCI) sponsored Face-To-Face GCP Courses*

^{*These courses meet 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.}

Face-to-Face GCP Training

To assist with the completion of this training, YCCI offers Face to Face GCP training (initial and refresher) at least twice a year for faculty and staff. These sessions are conducted by Linda Coleman, JD, Director, Human Research Protection Program, Office of Research Administration and Alyssa Gateman, MPH, CCRP, Associate Director, Quality Assurance and Monitoring, Yale Center for Clinical Investigation. Each session 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. 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.