What are some examples of potential Unanticipated Problems?

Quorum considers major protocol deviations and SAEs to be potential Unanticipated Problems. Additional examples of potential Unanticipated Problems that should be promptly reported include:

  • Unresolved research participant complaints
  • Adverse audit or enforcement actions
  • Breaches of privacy/confidentiality
  • Unauthorized use or disclosure of protected health information (PHI)
  • Loss of study records
  • Disappearance of study drug
  • Research staff misconduct affecting the research
  • Incarceration of a research participant
  • Injury sustained by research staff relating to the study
  • Suspension of principal investigator’s medical license
  • Higher than expected volume of adverse events
  • Higher than expected volume of protocol deviations
  • Higher than expected volume of participant drop-out rates
  • Complaint from a research participant involving an unanticipated risk that cannot be resolved by the research staff
  • New findings that may influence a research participant’s willingness to continue participation in the study