Ongoing Review of an Approved Study

Information concerning ongoing approved studies:

  • Annual Report
  • Final Report / Closure
  • Reportable Events

 

Annual Report

For REC paper files, a completed Annual Report must be submitted annually after approval of the protocol for review by the Committee.  A reminder letter will be sent to you one month before this report is due.

For IRISS files, a “Create a Renewal” activity button will appear in the file 30 days prior to the file expiry date. Complete the Renewal Summary Form and submit for review.  Reminder emails will be sent to you from IRISS.

 

Final Report / Closure

For REC paper files, a completed Final Report must be submitted for review upon completion or termination of the study.

For IRISS files, click the “Request Closure” button in the file. Complete the Closure Form and submit for review.

 

Reportable Events

The Clinical Trials Committee (CTC) has adopted the procedure for submitting reportable events developed by the Network of Networks (N2) and the Canadian Association of Research Ethics Boards (CAREB).  These include:

  • Local Adverse Events
  • Non-Local Adverse Events
  • Protocol Deviations
  • Audits
  • Privacy Breaches
  • Participant Complaints
  • DSMB / Interim Analysis Reports
  • Other

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