Most common Human Subjects Research Compliance audit findings

(source: DOCR)

  • Failure to follow the approved protocol consent
  • Subject signed the incorrect consent form version
  • Not re-consenting when appropriate
  • Research activities conducted prior to signing consent
  • Missing or incomplete data on Case Report Forms
  • Inappropriate documentation correction errors
  • Failure to document and/or report adverse events
  • Delegation log does not match the key personnel in eIRB
  • The RDSP in the eIRB does not match the current processes