Amendments

Any changes in the study protocol, IB, or information sheet/consent form must be detailed on an Amendment Form.

If in the investigator’s opinion, these changes could affect a subject’s willingness to participate, or adversely affect the risk/benefit ratio, an amended consent form must be submitted and further enrollment must be halted until the investigator has written approval to continue.’ In some cases, re-consenting of all study subjects may be necessary.

  • Advertisements for recruitment purposes not submitted at the time of initial application must be approved by the REB prior to use.
  • Any changes in reimbursements or incentives must be approved prior to implementation.
  • Any planned inclusion/exclusion waivers or protocol deviations that are predicted should be submitted on an Amendment form.
  • Any inadvertent deviation/violation must be reported to the REB on the Protocol Deviation Form