Forms and Guidelines

Notice for Participants, Sponsors, and Researchers: Changes to Clinical Trial Record Retention Periods

On February 11th 2022, Health Canada reduced the amount of time that clinical trial records need to be kept from 25 years to 15 years. These changes apply to clinical trials that involve drugs and/or natural health products carried out under these regulations.

Given these changes, Sunnybrook Researchers now have the option to change the record retention period for affected ongoing clinical trials to 15 years.

For more information on this change, please see Guidance for Participants, Sponsors, and Researchers: Information about the changes to Clinical Trial Retention Periods

For questions about this change, please contact the Research Ethics Office.


Version Date

Initial Submissions

*Initial submissions should be submitted through SunRISE
Informed Consent Form Template October 27, 2023
Informed Consent Form Checklist July 6, 2022


Protocol Amendment - Summary of Changes Table March 2, 2022
Study Impact Approval Form can now be found on the QA&E webpages

Although REB approval may be issued, study activation will not occur until all required authorizations are obtained and submitted to



Version Date

Research Ethics Board Guidelines - Incidental Findings April 18, 2022
Guidance for Participants, Sponsors, and Researchers: Information about the changes to the Clinical Trial Record Retention Periods July 28, 2022
Guideline for informed consent for research conducted remotely August 19, 2022
Sunnybrook REB Data and Safety Monitoring Plan (DSMP) Guidelines May 9, 2019
Guidelines for Research Study Participant Recruitment Materials: Advertisements, Flyers, Posters, Brochures etc. June 21, 2023

Applications for Medical Device Investigational Testing Authorizations Guidance Document

*Please see Appendix 3 for determining when an ITA application is required

October 1, 2018