Unanticipated Problem or Adverse Event Report
Date of the problem or event:
Describe the problem or event, including why or how it occurred.
Describe any actions taken in response to the problem or event.
Describe any actions that will be taken to prevent future occurrences of the problem or event. (Reminder: You must submit a protocol modification request if your action involves a significant deviation from the approved research protocol.)
Is it necessary to modify the informed consent form as a result of this problem or event?
Is it necessary to inform subjects who have already consented to participate in the study of the problem or event?