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Transitioning from OSIRIS to PittPRO: A Better Solution for HRPO

Join the HRPO seminar on October 8, 2018 to learn why changing from OSIRIS to PittPRO is necessary. PittPRO offers increased collaboration, regulatory updates, and a cloud-based environment for easier institution collaboration.

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Transitioning from OSIRIS to PittPRO: A Better Solution for HRPO

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  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

  6. Roll-Out Plan • Currently in beta testing: Contact askirb@pitt.edu for access to enter • Exempt & Expedited nearly 100 studies entered • October 15, 2018: ALLnew 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

  7. Transition Plan All active studies in OSIRIS will convert • When: Renewal date July 1, 2019or beyond • Enter as a new study; enter OSIRIS PRO# • Attach paper renewal form • NO modifications at conversion

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

  9. Navigation and Basic Tasks

  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

  14. Draft document accessible for editing • Final document with watermarking • Document History

  15. Combines tab for other submissions into one!

  16. Reviews: Latest Details

  17. Reviews: Shows Ancillary Details

  18. A Picture’s Worth a Thousand Words

  19. Start Me Up Submitting a new protocol QUESTIONS?

  20. Start Me Up

  21. *Red Star = required Q6 & 7: irb.reliance@pitt.edu Q8: Upload protocol or exempt form

  22. Required Sections

  23. Data Security No longer a separate form

  24. 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

  25. Tips, Tricks and Tools QUESTIONS?

  26. 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)

  27. Principal Investigator Listed on the Basic Info page

  28. Principal Investigator Detailed on Study Team Members page

  29. Can’t Touch This Consent forms MUST be submitted with tracked changes NOT highlighting!

  30. Reunited…and It Feels So Good!

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

  32. One stop to justify modifications -Rationale and support for the change being made

  33. Continuing Review (CR)

  34. Continuing Review: Study Status

  35. Reportable New Information One RNI: Multiple studies

  36. Reportable New Information

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

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

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

  40. Questions? If you need a certificate of attendance, email mgm12@pitt.edu

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