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Post-approval requirements

Following protocol approval, researchers are required to report the following to the Research Review Office:

• Research subject logs
  Upon protocol approval, investigators are required to keep research subject logs for all research study participants (unless they will remain anonymous), and are required to submit, to the Research Review Office, the subject log at the time of annual renewal, or on demand by the Research Ethics Committee. Subject logs must be recorded using the standard Research Subject Log Form (XLS).
• Amendments made to protocol during approval period
  Amendments to any of the approved research documents (e.g. protocol, consent form, advertisements, etc.) must be reported immediately using Form E - Immediate Reporting and Amendment (PDF).
• Serious adverse events and new study information
  Any unexpected/serious adverse event occurring during the course of the project that may affect the participation of research subjects, or any new information regarding treatment and intervention of patients, must be reported immediately using Form E - Immediate Reporting and Amendment (PDF).
• Annual renewal of protocol
  Investigators who wish to continue a protocol beyond the current approval period must inform the Research Review Office of this in writing at least one month before the approval period expires. When requesting an extension of the approval period, the investigator must submit a completed Form F- Interim Report (PDF).
• Terminating a protocol
  In order to terminate a research protocol, the investigator must submit a completed Form G - Termination Report (PDF).