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.