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Emory IRB System Upgrade: Impact on Submissions, Revised Templates, and Some Changes You Will See
October 18, 2019
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Topics to Cover Upgrade Impact: What you NEED to know
Importance of New Templates Other System Changes, and Preparation Tips Questions Topics to Cover
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Important Notice Upgrade targeted for Jan/Feb 2020, but… Dates on the following slides are subject to change
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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
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Impact on Submissions – Pre-Upgrade, Migration, and Go-Live
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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)
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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
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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…
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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
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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
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Jan 2020 Data Migration: WIRB/CIRB/XIRB
WIRB, CIRB, and other External IRB-Reviewed Studies: Submit throughout, but we may use alternate workflow
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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)
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New Required Protocol Templates
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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
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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
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Other Important System Changes
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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!
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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
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Preparation Tips
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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
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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?
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We are testing intensively and have volunteers from across the University, representing various types of users Testing
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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?
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