Post Approval Activities

How do I submit amendments, request for acknowledgements, annual renewals, etc?

All post approval activities such as amendments, request for acknowledgements, annual renewals, reports of Serious Adverse Events (SAEs) and completion of study notifications must be submitted for UBC C&W REB review electronically through RISe.

Amendments

Amendments for previously approved Clinical or Behavioural research projects must be submitted and approved by the UBC C&W REB prior to implementation. Please note that Investigator Brochures and Health Canada No Objection Letters (NOL) can only be submitted as an “Amendment” in the RISe system.

Request for Acknowledgements

Request for Acknowledgements are to be submitted to the UBC C&W REB for the following items:

  • Protocol Deviations (exemptions, violations or waivers)
  • Closed to accrual/enrolment, miscellaneous letters or information requirements REB acknowledgement, safety letters, study on hold / off hold

    >> Go to Templates to download the guidance notes

Completion of Study

The UBC C&W REB must be notified when a study is complete. The UBC C&W REB will acknowledge completion of a study, following which the study will be listed as “terminated” in RISe. Please note that once a study is terminated it cannot be amended or re-activated. 

Last Updated: 02/10/2012