Protocol Deviations

Protocol deviations are a departure from the procedures as described in the protocol without IRB approval. These departures may be accidental or due to negligence and may be major or minor/administrative in nature.

Protocol deviations may be a result of a problem with study oversight, training of personnel, or site study procedures. All deviations must be documented and submitted to the designated IRB. The principal investigator of the site, the study investigator, sponsor, and FDA (if the study is under an IND), must be informed according to the established procedures.

A protocol deviation may be:

  • A failure to do something required in the protocol.
  • Any action that is not required in the protocol.
  • A change in the procedure described in the protocol.

Measures should be taken to keep protocol deviations at a minimum. One of the strategies to achieve this is to develop protocols that include flexibility in the methodology where possible without adversely affecting subject safety or the integrity of the study.

Source: Attachment C: Recommendation on Protocol Deviations. (2021, June 16). HHS.Gov. Retrieved January 9, 2022, from