Continuing Review

Forms

Research Ethics Boards are obliged to ensure participant safety on an ongoing basis once a study has been approved ICH E.6 (Section 3.1.4)[ 21 CFR §56.109(f) and 45 CFR §46.109(e) ]. A report must be filed with Canadian SHIELD at least annually, but may be required more frequently based on the degree of risk for the trial participant. Included in the Continuing Review Update are: Summary of Enrolled Participants, Summary of Adverse Events, any changes to Study Staff, Summary of Protocol Deviations and any other significant issues that may impact to original REB approval.
A continuing review form will be sent to the Investigator approximately six (6) weeks prior to the Review Date. The continuing review form must be filled out completely and returned at least two (2) weeks before the due date.
If you have any concerns about a Continuing Review Reports, please contact CSERB or (905) 681 8661.