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.
Forms |
Version Date |
Initial Submissions |
|
*Initial submissions should be submitted through SunRISE |
N/A |
| Informed Consent Form Template | October 27, 2023 |
| Informed Consent Form Checklist | July 6, 2022 |
Other |
|
| 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 SIAF@sunnybrook.ca |
c
Guidelines |
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 |
