1. Patty Orndoff RN, MEd IRB Education Coordinator
University of Pittsburgh Institutional Review Board Presents: “OSIRIS” Online Submission for Institutional Reviews
Patty Orndoff RN, MEd IRB 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 notifications to permit direct communication between review entities and research staff
s to study team
sent to PI and Primary Research Coordinator
Internet based – available 24/7 with global access

4. Project Scope
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)

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

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

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:

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 Address and Password used to complete Education/COI modules

13. Home Page and “My Roles”

14. OSIRIS Application Triage section Cover sheet section Protocol 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. Able to upload multiple documents, one at a time
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 = MOD
Same study ID with consecutive version numbering
Unanticipated Problem = UAP
Includes both adverse events and other unanticipated problems

34. Sharing OSIRIS documents
Print or
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 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
We welcome written suggestions for enhancing the application

37. Need Some Playtime… Go to our Sandbox