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New Good Clinical Practice (GCP) Training Requirement

June 30, 2016

The NIH's National Center for Advancing Translational Sciences (NCATS) is leading an initiative to promote Good Clinical Practice (GCP) training to ensure that investigators who conduct clinical trials are appropriately trained. The Indiana Clinical and Translational Sciences Institute (CTSI) supports this training initiative as an essential step toward further ensuring the protection of trial participants and the quality of clinical trial results.

Accordingly, the IRB will require Good Clinical Practices (GCP) training for Principal Investigators and Co-Principal Investigators beginning July 1, 2016, for interventional clinical studies. New interventional clinical studies and renewals of interventional clinical studies submitted after July 1 will invoke this training requirement.

For the purposes of consistency and tracking, GCP training must be completed through the CITI program. CITI GCP training is valid for three years, and CITI GCP training completed within the last three years will be accepted. A GCP refresher course is now available in CITI for expired GCP courses. Sponsors may accept completion of CITI GCP training in lieu of sponsor-provided GCP training.

To complete GCP training in the CITI program, visit the IU CITI Program log-in page.