1. October 8, 2018 HRPO Seminar
Jean Barone, CIP – HRPO Director
Melissa Miklos, MSL, CIP – HRPO Associate Director

2. Why Change from OSIRIS? OSIRIS is old (2004) Extremely customized
Doesn’t play well with others

3. Huron’s IRB Solution: PittPRO
Increased collaboration:
Used by 40+ AAHRPP Accredited Institutions
Active User Group to share best practices
Incorporates regulatory changes as they occur
Common Rule, January 20, 2019
Includes Library, Toolkit and Help Center to support users
Single IRB Review models
Cloud-based environment to enable collaborating institutions to see each other’s work

4. University of Pittsburgh Integration
Cross-system sharing of information with rapid access to data (coming)

5. Development History Listened to feedback through lifetime of OSIRIS
Collaborated with Huron & University offices on products
Engaged Research Community in early stage development and testing and incorporated changes
Limited roll-out of PittPRO to willing researchers for Beta Testing
Mutli-Disciplinary task force was created to ensure that the system, historically leaning toward clinical trials, was streamlined to meet the needs of social-behavioral-educational researchers.
Study scope was developed as a result so that only relevant questions would show

6. Roll-Out Plan
Currently in beta testing: Contact for access to enter
Exempt & Expedited nearly 100 studies entered
October 15, 2018: ALL new EE submit to PittPRO
Full Board: Beta testing studies expected to go to committee in October 2018
January 2019: ALL new Full Board Studies submit to PittPRO
NOTE: if you put your full board study into the system without letting us know, it may be severely delayed!!!!

7. Transition Plan All active studies in OSIRIS will convert
When: Renewal date July 1, 2019 or beyond
Enter as a new study; enter OSIRIS PRO#
Attach paper renewal form
NO modifications at conversion
So really, you need to submit your Continuing Review/transition protocol in or around April.

8. Can’t Find My Way Home
Navigating your new Home Page and Study Workspace
QUESTIONS?

9. Navigation and Basic Tasks
Find Stuff: My Inbox
Submissions that require your action
Actions you can perform (create)
Shortcuts to access other items
Do Stuff
Review submissions in inbox
Check the state of items (e.g. Pre-Submission means you need to finish and submit)
Submit stuff
“Create new study” to start
Click on study name to open it

10. Home Page: My Inbox

11. Study Workspace

12. HISTORY shows what has taken place, similar to OSIRIS

13. CONTACTS: Shows info for all who have access
Gives contact info not just for study team, but for all others who have access – including ancillary reviewers

14. Draft document accessible for editing Final document with watermarking
Document History
Draft document accessible for editing
Final document with watermarking
Document History: ability to see all versions of document and choose two to compare

15. Combines tab for other submissions into one!

16. Reviews: Latest Details
Shows all of the latest details about reviews
Reviews: Latest Details

17. Reviews: Shows Ancillary Details
Shows all of the latest details about reviews
Reviews: Shows Ancillary Details

18. A Picture’s Worth a Thousand Words
Training Tab: I skipped this one but it gives the training records of the study team, just like OSIRIS

19. Start Me Up
Submitting a new protocol
QUESTIONS?

20. Start Me Up

21. *Red Star = required Q6 & 7: irb.reliance@pitt.edu
If you don’t have a protocol to upload, don’t worry – NO RED STAR!
Note Red Stars for mandatory answering
Question 6 & 7 – contact IRB reliance team
Question 8: Exempt Form goes here!
*Red Star = required
Q6 & 7:
Q8: Upload protocol or exempt form

24. Required Sections

25. Data Security
No longer a separate form

26. Ancillary Reviews Certain of them are selected based on response
Few can be manually selected
Link to extra info
Gives map to trigger questions
Scientific & Mentor in Pre- Submission
Others simultaneous in Pre- Review

27. Tips, Tricks and Tools
QUESTIONS?

28. Glossary Follow-On Submissions = Continuing Reviews
Follow-On Submissions = Modifications
Continuing Review (CR) = Renewal
Electronic Data Management = Data Security
Reportable New Information (RNI) = Unanticipated Problems (UAP)
Reportable New Information (RNI) = Adverse Events (AE)

29. Principal Investigator
Listed on the Basic Info page

30. Principal Investigator
Detailed on Study Team Members page

31. Can’t Touch This
Consent forms MUST be submitted with tracked changes NOT highlighting!
IRB cannot make changes or upload a “clean” copy.
A MODIFICATION would need to be submitted!!!!

32. Reunited…and It Feels So Good!
This is great but remember you need to give yourself more lead time because the modification may cause it to be approved subject to mods.
-be careful if your mod is expeditable because you CANNOT split the renewal and mod. If the renewal is full board, so is the mod and vice versa.

33. Modifications Mod “cover sheet” incorporated into modifiable protocol
Exempt studies can be modified like any other

34. One stop to justify modifications -Rationale and support for the change being made
Note the RED STAR by #3
Explain WHAT is being changed and WHY

35. Continuing Review (CR)

36. Continuing Review: Study Status

37. Reportable New Information
One RNI: Multiple studies

38. Reportable New Information

39. I Still Haven’t Found What I’m Looking For

40. HELP! I Need Somebody! 412-383-1480 Main IRB number askirb@pitt.edu
General IRB questions
Technical Issues

41. Let’s give it a try http://www.pittpro.pitt.edu/

42. Questions?
If you need a certificate of attendance,