A Message from the University of Pittsburgh Institutional Review Board

OSIRIS Tip of the Week

Submitting Unanticipated Problem Reports in OSIRIS

When submitting Unanticipated Problems, including Adverse Events and Other Unanticipated Problems, you are not required to complete the forms found on the IRB website for studies in OSIRIS.  Instead, reports must be submitted through the OSIRIS system.  Please follow the guidelines below to submit this information to the IRB.

  • For new Unanticipated Problems or Adverse Events not previously reported to the IRB:
    • Open the protocol and click on the “New Unanticipated Problem” button on the left side of the screen, then complete the report by answering the questions.
    • When you receive multiple reports from the sponsor at the same time regarding an event which meets reporting guidelines and has not yet been submitted to the IRB, submit all available information as your initial report, including the initial and follow-up information received from the sponsor.
  • For follow-up information related to a current UAP (that has already submitted and is under review by the IRB):
    • Please contact the Adverse Events Coordinator, Jamie Zelazny, at zelaznyjh@upmc.edu for guidance on how to incorporate this information based on where the UAP is in the review process.
  • For follow-up information related to a past UAP (in the ‘Review Complete’ state):
    • Find the original UAP by opening up the related study and clicking on the ‘Unanticipated Problems’ tab and open it.
    • On the left hand side of the screen you will see a link that says “Create Follow-up Report”.  Click on that link, and a window will pop up.
    • Read the instructions and then click OK in the lower right hand corner.  A follow-up Unanticipated Problem report is created with instructions on how to access and fill it out.
    • As a mechanism to keep follow-up reports grouped with the original report, the follow-up report will have the same ID number as the original, but with a hyphen and a sequentially generated number appended to the end (ex: initial report was UAP08010123, the first follow-up report would be UAP08010123-01).