Emory IRB System Upgrade: Impact on Submissions, Revised Templates, and Some Changes You Will See

1. Emory IRB System Upgrade:Impact on Submissions,Revised Templates,and Some Changes You Will See October 18, 2019

2. Topics to Cover

3. Important Notice Upgrade targeted for Jan/Feb 2020, but… Dates on the following slides are subject to change

4. Migration/upgrade will impact your submissions, and our turnaround times, and require attention and adjustment • Data Migration is always a challenge • Hopefully helped by using same vendor, similar-looking interface • Migrated studies will need some filling-in • For more information about our usual turnaround times: http://www.irb.emory.edu/about/IRB%20Target%20Turnaround%20Times.html

5. Impact on Submissions – Pre-Upgrade, Migration, and Go-Live

6. Pre-Upgrade: Continuing Reviews - Submit Renewals Early! • All studies expiring January/February 2020: Submit your continuing review by: • November 1st for Full Board • November 15, 2019 for expedited studies • Otherwise, hold until new system goes live • Review list of studies expiring in those months(search PI name)

7. Pre-Upgrade: Reportable Events - Business as Usual • Submit Reportable Events as usual in the current eIRB system, then new system once it goes live, and your study is migrated • Until Winter Recess (December 2019): Submit New Studies in old system Note: IRB and other ORA offices are completely closed during Winter Recess

8. Pre-Upgrade: New Studies - Note Deadlines… • Until Winter Recess (December 2019): Submit New Studies in current system Note: IRB and other ORA offices are completely closed during Winter Recess • After Winter Recess…

9. Jan 2020 Data Migration: New Study Slowdown • Starting 1/7/2020: Strategic slowdown of NEW STUDIES through 1/31/2020 (“go live”) • Submissions limited to interventional studies with these criteria: • Competitive enrollment or contractual obligation for quick start-up (e.g. NCI grant) and • IRB is limiting factor in start-up (i.e. do not submit if contract, etc. will not be ready) • Others: hold until new system go-live (consult IRB leadership if special concerns) • Any studies submitted: need to wrap up within 90 days of go-live so they can be migrated in second round; otherwise may need to recreate in new system

10. Jan 2020 Data Migration: Other Submissions Slowdown • Starting 1/7/2020: Strategic slowdown of MODIFICATIONS through 1/31/2020… • Only submit if updating protocol, IB, consents, or other study documents when: • required by Sponsor deadline and/or • safety/welfare of subjects is affected • Modifications for non-urgent changes: Hold until go-live • Starting 1/7/2020: Hold CONTINUING REVIEWS until new system go-live

11. Jan 2020 Data Migration: WIRB/CIRB/XIRB • WIRB, CIRB, and other External IRB-Reviewed Studies: Submit throughout, but we may use alternate workflow

12. Upgrade Overview

13. New Required Protocol Templates

14. Importance of New Templates

15. New Protocol Templates • Templates available now at: http://www.irb.emory.edu/eirb_project_huron_saas/New_Templates.html • Includes: • Biomedical Protocol • Socio-behavioral Protocol • Site Supplement to Sponsor Protocol • Retrospective Chart Review Protocol • Secondary Analysis Protocol

16. Other Important System Changes

17. Other system changes – Staff Changes Requests to add/remove study team members: • Currently: using online tool, no need for eIRB amendment • New eIRB: all staff changes will require an amendment • Good news: only one form, so easy to complete • It will not require PI sign off if he/she identifies a proxy for submission • With this type of amendment, another amendment can be open at the same time!

18. Other system changes – Ancillary Reviews Department Review and other Ancillary Reviews • Are no longer automatically triggered by eIRB questions. Study team and IRB staff set the required reviews (IRB staff correct study team selections when needed) • Department review and CTRC review: now in parallel with IRB review, not prior to IRB review • Those approvals must be in place before IRB can issue full approval • Office of Quality Sign-off will no longer prevent IRB approval… but • All applicable sign-offs must still be obtained before starting research at EHC • Failure to do so may result in corrective action

19. Preparation Tips

20. How should I prepare for the transition? • Renew studies early if expiring Jan/Feb 2020! • See if your studies are on the list (search PI name): • Save your study documents in old system to fulfill Emory retention requirements! • Only active studies and those closed within the last three years will be saved in the new system during data migration • Not all documents will be in right places right after migration • Have your current stamped consent forms saved off in case of migration glitches • Prepare to be trained… • Videos, job aides, and Zoom and in-person training

21. How will I stay informed? • Webinars: find future installments and previous recordings at http://www.irb.emory.edu/Training/webinars.html • Website: dedicated page with updates at http://www.irb.emory.edu/eirb_project_huron_saas/announcement.html • Email blasts: if not receiving these emails, contact Jessica Blackburn at jessica.blackburn@emory.edu to be added to the email group • In-person training: we will be in contact with University Departments to offer in person trainings. If you are interested, email Shara Karlebach at swilli7@emory.edu • Zoom Training: we will offer training sessions at the end of the year when the system is ready for training and testing. We will post dates when we know more • Videos: the vendor (Huron) will create training videos that will be available in our website (in process)

22. Testing We are testing intensively and have volunteers from across the University, representing various types of users

23. What if I have additional questions? If you have additional questions, contact any member of our staff leadership at http://www.irb.emory.edu/about/staff.html#tab2