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

2. Topics to Cover Upgrade Impact: What you NEED to know
Importance of New Templates
Other System Changes, and Preparation Tips
Questions
Topics to Cover

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

4. Data Migration is always a challenge
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: %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 Nov 2019 24 Dec. 2019 – 1 Jan. 2020 7 Jan, 2020
Submit CONTINUING REVIEWS early
24 Dec – 1 Jan. 2020
Emory Winter Recess
7 Jan, 2020
Start of New Submission/AM SLOWDOWN
31 Jan. 2020
New System Go live (anticipated)

13. New Required Protocol Templates

14. Importance of New Templates
Streamlined smartforms have fewer questions
Protocols will now need to cover those items
Critical: you must use our templates!
For external protocols: you must use our site addendum
Importance of New Templates

15. New Protocol Templates
Templates available now at: as/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 .html
Website: dedicated page with updates at n_saas/announcement.html
blasts: if not receiving these s, contact Jessica Blackburn at to be added to the group
In-person training: we will be in contact with University Departments to offer in person trainings. If you are interested, Shara Karlebach at
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)
How will I stay informed?

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

23. What if I have additional questions?
If you have additional questions, contact any member of our staff leadership at
What if I have additional questions?