As part of the efforts to promote research excellence, and to ensure compliance with relevant research guidelines and regulations, there are new mandatory education requirements. Knowledge of and compliance with Tri-Council Policy Statement (TCPS), Good Clinical Practice (GCP), the Health Canada Food and Drugs act – Division 5 and the adopted N2 CHEO RI standard operating procedures (SOPs) provide assurance that research data are credible and accurate, and that the rights, safety, confidentiality, and well-being of trial participants are protected. GCP and Division 5 must be followed in studies that come under Health Canada jurisdiction (i.e., regulated clinical trials). These guidelines should also be followed in other clinical investigations that can have an impact on the safety and well-being of research participants.
When is the deadline?
Effective September 5, 2017, REB initial approval for regulated research studies (drug, device or natural health product) will only be granted to those investigators and their staff listed on the REB application who show evidence of completed training on the adopted N2 CHEO RI Standard operating procedures.
As of April 1, 2015 all investigators and research staff are required to have the approriate CITI training certification for adopted N2 SOP, TCPS, GCP and/or Health Canada Food and Drugs act – Division 5. REB initial approval of new submissions and annual renewal approvals of ongoing studies will only be granted to those investigators who have appropriate certification of training for themselves and all of their research staff.
Who is required to complete training?
- All CHEO investigators and research staff are required to secure TCPS certification;
- All CHEO investigators and research staff conducting clinical trials are required to secure GCP certification;
- All CHEO Investigators and research staff conducting regulated clinical trials are required to secure Health Canada Food & Drugs act – Division 5 certification. These include drug, medical device or natural health product Phase I – IV clinical trials.
Where do you complete the training?
The SOPs are posted on CHEONET under the Research Institute. After review of the SOPs, please complete the REDCap test. Upon completion of a passed test, you will receive a certificate of completion, and the Quality and Risk Management office will be notified.
CHEO Research Institute is a member of Network of Networks (N2). This membership provides CHEO Researchers access to the CITI-Canada Online Training which includes the following online courses:
- The Biomedical Research Ethics Tutorial (TCPS)
- Canada GCP (Good Clinical Practice)
- Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects
The CITI-Canada Online Training allows you to create your own user name and password to log in and out and save your progress so that you can take this training at times that are convenient for your work schedule. Please ensure that you choose Canada-English from the dropdown menu in the upper left corner of the webpage. When you have completed the training, you’ll be able to print off or save a copy of your record of completion for your training files and for submission to ROMEO for REB initial approvals and continuing approvals.
Where do I upload my certificates?
Please email Ms. Sabrina Hamer [email protected] with your TCPS, GCP and Division IV certificates if you are new staff of CHEO or CHEO RI. For the adopted N2 CHEO RI SOP training, the Quality and Risk Management office will be notified upon completion of a passed test.