IRB Adverse Events Report

Reportable adverse events are (1) severe, (2) related to your study, and (3) unexpected.

Principal Investigator (PI)
Email
Protocol Number
Title of research study/QI project
As PI of this study:

As PI of this study: I am reporting unanticipated events that may be related to the above identified protocol. These events, if related to this study/project, may place subjects at greater risk of harm than was previously known.
1. Describe the possible adverse event.
2. Where did this event occur?
3. Was this event previously reported to the IRB?

3. Was this event previously reported to the IRB? Yes No
4. What actions, if any, have you taken in attempt to protect human subjects from subsequent similar events?
5. In light of this potential adverse event, should the consent form be revised?

5. In light of this potential adverse event, should the consent form be revised? Yes No
If yes, attach revised version, with new version identifier.

Attach Files
6. In light of this potential adverse event, should any part of the study/project plan or methodology be revised?

6. In light of this potential adverse event, should any part of the study/project plan or methodology be revised? Yes No
If yes, attach revised version, with new version identifier.

Attach Files
7. Should currently enrolled subjects be re-consented?

7. Should currently enrolled subjects be re-consented? Yes No
Upload your plan for notification of subjects and re-consenting, with new version identifier.

Attach Files
8. Signature:

Draw or Type

An IRB member will contact you to discuss this report. I understand this is a legal representation of my signature. Clear

Full Name

An IRB member will contact you to discuss this report. I understand this is a legal representation of my signature.