Informed Consent Tips

  • An Informed Consent process should be clearly documented
  • The Informed Consent process should be referenced for each subject
  • No study procedures can be performed prior to being properly consented
  • Re-consent should occur if an amendment has occurred or PI change
  • Subject shall print, sign, date and time for themselves the informed consent form (same with the study coordinator or PI)
  • An entire copy of the signed and dated informed consent should be sent home with the subject