What is a “major” protocol deviation?

Under Quorum’s guidelines, examples of major protocol deviations include:

  • Failure to obtain informed consent
  • Informed consent obtained after the initiation of study procedures
  • Omitting study procedure(s) required by approved protocol
  • Performing a study procedure that is not outlined in the IRB-approved protocol
  • Failure to report a Serious Adverse Event
  • Drug dispensing/dosing error
  • Failure to securely control the study product
  • Enrolling participants outside of inclusion criteria
  • Failure to follow a Safety Monitoring plan
  • Study visit outside of window, only if in the opinion of the investigator, if affects the safety or welfare of the research participants or others, the rights or participants or other or the integrity of the study design.
  • Use of an unapproved consent form