Tips

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