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Full Study Title: A Randomized Comparative Trial of Pediatric Vision Screening Devices and Cost-Effectiveness Analysis of School-age Children Vision Screening Program in Ontario

Qualified/Principal Investigator (QI/PI): Agnes Wong

REB File #:1000045972

Standard Operating Procedure: Deviation from Protocol

  1. If a deviation from protocol occurs, staff must complete a Note to File which will be given to the Research Coordinator

  2. An example of a deviation from protocol that may occur in this study is that a child is tested on an order which differs from their randomized order of tests since randomization is occurring at the individual level

  3. Protocol deviation. A protocol deviation occurs when, without significant consequences, the activities on a study diverge from the Institutional Review Board-approved protocol, e.g., missing a visit window because the subject is traveling. Not as serious as a protocol violation.

  4. Protocol violation. A divergence from the protocol that materially

    • reduces the quality or completeness of the data,

    • makes the Informed Consent Form inaccurate, or

    • impacts a subject's safety, rights, or welfare.

    Examples of protocol violations may include the following:

    • Inadequate or delinquent informed consent

    • Inclusion/exclusion criteria not met

    • Unreported serious adverse events

    • Improper breaking of the blind

    • Use of prohibited medication

    • Incorrect or missing tests

    • Mishandled samples

    • Multiple visits missed or outside permissible windows

    • Materially inadequate record keeping

    • Intentional deviation from protocol, Good Clinical Practice, or regulations by study personnel

    • Subject repeated non-compliance with study requirements

  5. Research Coordinator will enter the deviation from protocol in the Study Protocol Deviations/Violations Tracking Log and include the Date of Event, Participant ID#, Description of Event and whether it was a deviation or violation.

  6. PI will sign off on the Study Protocol Deviation/Violation Tracking Log