Protocol Deviations

Protocol Deviations comprise of any unapproved discrepancies from a protocol research plan or Good Clinical Practice Guidelines (GCP).

Protocol Directors or their designee must document all protocol deviations in the participant’s study records in a narrative summary or on a case report form.
Any deviation that affects the safety of participants, impacts study endpoints, or is IRB reportable must be documented in OnCore by the research staff.
Any deviation that is IRB reportable must be sent to the CCTO Regulatory Manager using the Adverse Event Communication Form and submitted to the IRB by the research staff using eProtocol.
Failure to properly document deviations may result in DSMC and IRB corrective action such as a temporary hold on enrollment, or study closure.