Parent Page: Offices id: 31281 Active Page: Unanticipated Problemid:32935

How to Submit an Unanticipated Problem Report Form

If you need to submit an Unanticipated Problem Form, please follow the instructions below.

  1. Log into iRIS (
  2. Click on "View and Manage My Studies" on the left (under Featured Study Operations) and open your study.
  3. Click on the link to the left of the screen for “Unanticipated Problem (UP) Report Form”.
  4. Select “Add a New Form”.
  5. Respond to the questions and click the “Save and Continue” button in the top right to move through the various sections. Be sure to provide a detailed description of the unanticipated problem.
  6. At the end of the form, you should select the “Signoff and Submit” button.
  7. Select “Approve”, input your 4x4 and password, and select “Save Signoff”.

Please see SOP 407: Protocol Deviations and Unanticipated Problems for more information.