Wednesday, April 03, 2019 Update regarding Good Clinical Practice Revision 2 Please be aware that there have been training updates for the Good Clinical Practice Revision 2 implementation. As background, GCP Revision 2 was approved by the ICH regulatory committee November 6, 2016 and Health Canada will implement Revision 2 April 1st, 2019. CCTG communicated a 3 year expiry for GCP certification in spring 2018. The Office of Compliance and Oversight has revised the current GCP training to include Revision 2. The revised GCP training course will be available for new members who have not yet trained in GCP. A GCP refresher module, including the revision 2 updates, was created for members who have previously completed a GCP training course. The target date to release the modules is March 27, 2019. The GCP training will be valid for 3 years from the date of completion. This training is mandatory for all members conducting clinical trials per CCTG SOPs and in compliance with NIH policy. As of July 1, 2019, following a 3 months grace period, members without completion of the refresher module or a GCP training course including the Revision 2 content will be unable to be added to a Participant’s List and for those already on a Participant’s List, randomization and registration access may be suspended. Reciprocal GCP training courses will continue to be reviewed by CCTG. Please send any questions to training@ctg.queensu.ca
