OSIRIS: Streamlining Institutional Reviews with Online Submission

1. University of PittsburghInstitutional Review Board Presents:“OSIRIS”Online Submission forInstitutional Reviewswww.osiris.pitt.edu Patty Orndoff RN, MEdIRB Education Coordinator

2. OSIRIS Introduction • Single, dynamic, comprehensive electronic compliance system • Utilizes smart forms which provide extensive branching questions to acquire information • Automated review process based on responses in smart form • Single submission process for required pre-IRB approvals and IRB review

3. OSIRIS (con’t) • Automated logging and tracking system • Automated email notifications to permit direct communication between review entities and research staff • Emails to study team • sent toPI and Primary Research Coordinator • Internet based – available 24/7 with global access

4. New Studies – Full Board, Expedited and Exempt (March 2007) Renewals Modifications Unanticipated Problems (includes adverse events) Exceptions (pending) Suspensions Terminations Committee Meetings Help/Support Paper Conversion process (TBA 2008) Project Scope

5. Getting Started……… • Logging on requirements • Build the application • Submit for review • Final Approval

6. Mentor Department/CTRC Review Scientific Review Committees UPMC Research Fiscal Review RDRC/HUSC (radiation) Institutional Biosafety Committee (IBC) Conflict of Interest Pre-IRB Reviews

7. Notification Occurs Automatically When Investigator Submits the Study to OSIRIS • Investigational Drug Service • CTRC (if resources are utilized)

8. Log In Requirements • All personnel involved with Human Subject Research are required to complete Internet-Based Studies in Education and Research (ISER) training • Required modules include: • Module 1 - Research Integrity and • Module 2 - Human Subject Research • 2a (Biomedical) or • 2b (Social/Behavioral) • ISER training is an online training system which can be found at: https://cme.hs.pitt.edu

9. Principal Investigator Role • Responsible for the conduct of the study • Only the PI can submit a project for review • Carefully review the entire document before submitting • Must respond to all concerns expressed by reviewers Do Not share your password!

10. Study Coordinator Role • Prepare study information • Enter data into Osiris • Scan documents if needed • Contact sponsor if needed • Track study progress in system over time • Note: Only the PI can submit the IRB application to OSIRIS

11. OSIRIS Home Page

12. Login Page Entire Email Address and Password used to complete Education/COI modules

13. Home Page and “My Roles”

14. OSIRIS Application • Triage section • Once completed, all names listed in the application will have access to the study • Cover sheet section • Demographic and site information • Protocol section • Protocol development

15. Getting Started

16. Create New Study Help Text

17. Drop-Down List Provides Quick Access to Specific Sections(Do not use for Exempt Studies)

18. Who can initiate the submission? • Any member of the research team can start developing the application but…. • The person who initiates the study is automatically listed as the PI • If you are not the PI • Go directly to the section CS3.0 and correctly identify the PI

19. Select or Change PI

20. Uploading Documents Able to upload multiple documents, one at a time

21. Consent Form Templates Click “Add” to upload new consent form(s) or “Edit” to revise any previously uploaded consent form(s)

22. Revise Consent Form Click on “Edit” to upload revised form (i.e., modify consent or respond to comments)

23. Consent Form Watermark Footer

24. View Progress

25. Hide/Show Errors

26. Submit Project for Review

27. “Current State” and “History” Both Show Application is in IRB Review

28. Changes Required by IRB Staff Click on Underlined Text beside “jump”; you will be redirected to specific page to insert your response to comments When you “Click here to respond” a textbox opens so you can indicate what changes are completed or disputed

29. “IMPORTANT” Complete the changes requested within the application (SAVE) and then use the Click here to document that you made the change 2nd 1st

30. “Current State” Shows Study is Approved and the Approval Letter & Consent Forms are Available

31. Reviewer Version

32. Approval Letter

33. Project ID • Study name = PRO07010001 • Renewal name = REN08010034 • Assigned new ID • Modification name = MOD07010001-01 • Same study ID with consecutive version numbering • Unanticipated Problem = UAP07060004 • Assigned new ID • Includes both adverse events and other unanticipated problems

34. Sharing OSIRIS documents • Print or email • Reviewer Version • Includes all questions/responses • html format • Attachments • Consent forms in Word • All uploaded documents • Open document, save to your computer, and attach to an email message or server if needed

35. IRB Website (www.irb.pitt.edu)

36. Contact us by clicking on the Help tab located on each page of OSIRIS or email us at irb@pitt.edu • OSIRIS training – contact Patty Orndoff orndoffpa@upmc.edu • We welcome written suggestions for enhancing the application

37. Need Some Playtime… Go to our Sandbox