Post Approval Activities (PAA) are all submissions made to the REB after initial ethical review and Institutional Approval is issued.
There may be fees for ethical review of amendments and annual renewals for 'for-profit' studies, such as sponsored clinical trials.
Please refer to REB Administration Fee for Industry-Sponsored Studies for clarification.
Please contact us if you are unsure if your study is required to pay fees.
Changes in approved research studies may not be initiated without prior REB review and approval. The only exception to this rule is when a change is necessary to eliminate apparent immediate hazards to human participants. Such a change must subsequently be reported to the REB.
Researchers must submit an Amendment Application Form through the Research Services Portal for both major and minor amendments.
Please note if no changes have been made to the study, but you have documents which must be submitted to the REB for review and acknowledgement, an Unanticipated Event Report should be used. Please see the information below about acknowledgement.
Major Audit and Inspection Observations or Enforcement Actions
All major audit and inspection observations must be reported to the REB by the PI. This includes enforcement actions taken against the local PI or research site.
Reports to the REB should be submitted within 10 working days. However, where there are observations that immediately impact the safety of participants or significantly impact data integrity, notification should be made to the REB office as soon as the PI becomes aware of the situation.
The Unanticipated Problem Report form should be used in both cases.
How to report events occurring external to the local research site
Please submit the following information to the REB as a Non-Local Safety Event using the Unanticipated Problem Report form in the Research Services Portal:
- Summary or Listings of External SAE Reports (CIOMS, MedWatch, IND Safety reports, etc.)
- Reports, publications, or interim results or findings (DSMB notifications, 'Dear Healthcare Professional' Letter, etc.)
- New or updated study product safety information (Revised label/ Package Inserts, Device manuals, etc.). Note: Investigator’s Brochures must be submitted using an amendment application.
- Recalls / Withdrawals (Regulatory Agency or Sponsor Marketing withdrawal, etc.)
- Annual Renewals
Ongoing studies must be reviewed at least annually to ensure they continue to be conducted as described in the initial approval. The annual renewal process can be completed within the Research Services Portal and are submitted by the Principal Investigator or their delegate.
The Principal Investigator or other identified study main contact will receive a reminder approximately six (6) weeks before the study date.
If the study is not renewed prior to the expiry of the current Research Ethics Approval, it will be considered as lapsed and you will be unable to conduct research activities until such time as the renewal is in place. In addition, the lapse will be reported to the department head(s) where the research is taking place. If access to funding is contingent on active research ethics approval, Finance will also be notified. We may also be required to notify the funding agency, study sponsor, and/or regulatory authorities of the lapse of approval.
- Notification of Study Closure
The Principal Investigator is required to notify the REB when the study is ready to be closed (i.e. when there are no active study activities with participants, and the study can be archived for the requisite period of time indicated in the application). Please submit the Study Closure form in the Research Services Portal.