A protocol deviation is an incident involving noncompliance with the protocol, but one that typically does not have a significant effect on the subject’s rights, safety, welfare, and/or the integrity of the resultant data. Deviations may result from the action of the participant, investigator, or staff. Examples of protocol deviations include (not an exhaustive list):

  • Signed copy of consent form not given to subject during informed consent process
  • Subject does not begin treatment within 2 months following randomization
  • Subject does not have assigned treatment within 6 months after randomization
  • Subject does not pursue either treatment (surgery or physical therapy) within 12 months after randomization
  • Follow-up questionnaire not sent to subject for designated time point