Study amendments
- All planned changes to a study protocol must receive approval prior to implementation and must be submitted to the office on an amendment request form.
- Amendments may be minor in nature e.g., administrative changes such as the addition of a co-investigator or major e.g., additional study interventions which may alter the risk-benefit ratio.
- A change in the study funding source e.g., funding is secured from a commercial sponsor after study commencement, or alternatively, withdrawal from study sponsorship, is considered an amendment and will require approval from the REB. Revised consent forms noting the change in study sponsorship should be attached to the amendment request form. Contract administration must also be notified about budget amendments.
- Major amendments will routinely require satisfactory science review and this should be attached to the amendment request form. To facilitate the review, investigators are encouraged to recruit the same reviewers as reviewed the original protocol.
- Revised consent forms must be appended to a request for study amendment with the proposed revisions highlighted for review. A new consent and assent form version date footer should be noted. Forms should be revised using the current consent form template posted on this website in the consent & recruitment section.
- Proposed amendments are normally reviewed and approved by the Chair. Full Board review will be conducted at the discretion of the Chair or as required under Health Canada regulations for Health Canada approved clinical trials.
