An unanticipated or unintentional divergence or departure from the expected conduct of an approved study that is not consistent with the current approved research protocol, consent document or study addenda.
Deviations may or may not have a significant effect on the research participant’s rights, safety or welfare, or on the integrity of the data. Deviations are different from amendments in that they generally apply to a single occurrence or participant and are not intended at the time to modify the entire protocol.
All protocol deviations must be reported to the Research Ethics Board (REB) within 15 days of the St. Michael’s Hospital study team’s awareness of the event.
For more details, read the guidelines for reporting protocol deviations.