Emory IRB System Upgrade Impact on Submissions Revised

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

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

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

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%20 Target%20 T urnaround%20 Times. html

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

Pre-Upgrade: Continuing Reviews - Submit Renewals Early! All studies expiring January/February 2020: Submit your continuing review by: November 1 st 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)

Pre-Upgrade: Reportable Events - Business as Usual Submit Reportable Events as usual in the current e. IRB 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

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…

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

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

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

Upgrade Overview Submit CONTINUING REVIEWS early Start of New Submission/AM SLOWDOWN 24 Dec. 2019 – 1 Jan. 2020 Nov 2019 31 Jan. 2020 7 Jan, 2020 Emory Winter Recess New System Go live (anticipated)

New Required Protocol Templates

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

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

Other Important System Changes

Other system changes – Staff Changes Requests to add/remove study team members: Currently: using online tool, no need for e. IRB amendment New e. IRB: 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!

Other system changes – Ancillary Reviews Department Review and other Ancillary Reviews Are no longer automatically triggered by e. IRB 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

Preparation Tips

Renew studies early if expiring Jan/Feb 2020! How should I prepare for the transition? 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

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_sa as/announcement. html Email blasts: if not receiving these emails, contact Jessica Blackburn at jessica. blackburn@emory. edu to be added to the email group How will I stay informed? In-person training: we will be in contact with University Departments to offer in person trainings. If you are interested, email Shara Karlebach at swilli 7@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)

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

If you have additional questions, contact any member of our staff leadership at http: //www. irb. emory. edu/about/staff. html#tab 2