What is a “minor” protocol deviation?

A minor protocol deviation is a protocol violation that, in the investigator’s judgment, does not adversely affect the risk/benefit ratio of the study, the rights, safety, or welfare of the participants or others, or the integrity of the study. Examples of minor protocol deviations include:

  • Study procedure conducted out of timeframe
  • Study visit out of timeframe
  • Participant failure to initial every page of the consent form
  • Copy of consent form not given to participant during informed consent process
  • Site over-enrollment
  • Participant failure to return diary
  • Missing original signed consent, but have a copy of the participant signed consent

Minor protocol violations do not need to be reported to Quorum Review IRB.