aura- irb fundamentalsaura.uchicago.edu/sites/aura.uchicago.edu/files/uploads/... · 2019. 5....
TRANSCRIPT
AURA-IRB
Fundamentals
1
Agenda 2
Introductions
Websites/Resources
Training Opportunities
Background
FAQs
Additional Benefits
Roles
AURA Help Desk
AURA Listserv
System Notifications
System Overview Personal Workspace
Study Workspace
Smart Forms
Navigation
Activities
Introductions 3
AURA-IRB Trainers Aaron House, [email protected]; 4-1622
Candace Washington, [email protected]; 2-2925
Attendees
Anything specific you are hoping to get out of today’s session?
Any questions you want to make sure are addressed before you leave?
AURA-IRB Reporting 4
Questions about the data warehouse? How to pull reports?
AURA-IRB Reporting Help Desk:
Kim Griffin
Senior BI Analyst
Business Information Services/IT Services
The University of Chicago
(773) 834-2653
David Weiland
ITS/Business Information Services
The University of Chicago
(773) 702-8931
Websites/Resources
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Websites/Resources 6
AURA Project (http://aura.uchicago.edu) Training Section
http://aura.uchicago.edu/page/aura-irb-training
IRB Offices Links to each office on the AURA Homepage
Training Opportunities
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Training Opportunities 8
Initial Submission (IS) classes Separated by type of research
BSD- Drug/Device/UCMC Patients
SBS & SAA - Surveys, Interviews, Focus Groups, Observational/Psychological Testing
AURA IRB - Additional Workflows (AM/CR/UP) NOT separated by the type of research
For all research types (BSD, SBS, SAA/Chapin Hall)
AURA IRB - Department Administrators Primarily for grants and contracts administrators who prepare
funding proposals with human subjects.
Training Opportunities 9
Department specific sessions As requested
As availability permits
One-to-one sessions As requested
As availability permits
Background
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Background 11
Huron Consulting Group / Huron Education Offers a series of modules (Click Commerce)
We currently have deployed the Grants modules (AURA-Grants)
AURA-IRB is currently rolling out April 2nd
AURA-COI will be the next module implemented
Once stabilization occurs in all three module, a needs assessment can again be conducted and we can plan accordingly for the future.
These modules are highly customizable Future optimizations are already in the works for AURA-Grants
These on-line systems will updated regularly
FAQs
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FAQs 13
Why are we moving to a new system? We have IRB-Wise for the BSD and SBS after-all? IRB-Wise was a “home grown” solution
It is not a sustainable solution
No longer internally supported
No plans for future updates
The Huron/Click modules are an out of the box solution that is highly customizable Our own programmers/analysts work with the Click developers
Modules are in many educational institutions across the country
FAQs 14
One system for all Human Subjects researchers BSD, SBS, SAA/Chapin Hall
Reduce the administrative burden on faculty and staff
Only the questions that are applicable to your research protocol
Reduce the regulatory compliance risk for the University All IRBs are using the same set of questions/smart forms
Transparency for the research team Can what state the study is in Can see any history associated with the protocols
FAQs 15
How will the data from the current IRB-Wise system be imported into AURA-IRB? Conversion will be done electronically
Manual corrections for converted data (as necessary)
Issues Smart form may reflect outdated version of study
New questions – will not be answered
Legacy View For all converted records
Can see the data from the original record in IRB-Wise
Use to answer required fields in AURA-IRB
Additional Benefits
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Additional Benefits 17
Main Application always displays the current depiction of the study Can view previous versions in the “snapshots” Alleviate versioning issues
Question validation & “Hide/Show Errors” COI & Training (HSP) Information tracked in system Approved Documents in one place Create study templates PI/C0-Investigator lists Standard language
Recruitment Confidentiality precautions, etc.
Additional Benefits 18
Reporting Capabilities Department Administrators can request access to the
data warehouse from their respective IRB office.
Pull pre-built reports or customize their own
The Reporting Team will be conducting trainings (dates to come). The reporting go-live dates is roughly two weeks after AURA-IRB
goes live
Roles
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Roles 20
Your roles in AURA-IRB will be set-up for you Registered User
Everyone who gets a paycheck from the University will have this role automatically
You’ll be able to log into the system
Additional roles will be predetermined by the AURA-IRB Functional Team in conjunction with the appropriate IRB Director(s).
If you need additional roles/access in the system Email the AURA Help Desk and they will coordinate the proper
addition/access accordingly
AURA Help Desk
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AURA Help Desk 22
AURA has dedicated support staff Email [email protected] for system related
questions. I can’t log in from off campus. Help!?
I can’t find the study I started yesterday. Help!?
How do I add people to my research team?
How do I route a study to the IRB for review?
Where do I find my approval letter?
You may also email non-system related questions and the HD will follow up with the appropriate parties and respond accordingly with the answer or your next steps for a solution.
If you would prefer to speak with a person, just send the HD a quick email that says, “Please call me @ 1-1234”
AURA Help Desk 23
Please also continue to reach out to your normal channels of support IRB Staff and Directors
Any other supporting office
AURA Listserv
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AURA Listserv 25
Subscribe to the new AURA-IRB listerv: [email protected] This listserv communicates important announcements to
the IRB community. Training offerings, help tips, system enhancements and other
related information
The link to sign up: https://lists.uchicago.edu/web/info/aura-irb
AURA Listserv 26
If you are in the BSD-IRB also subscribe to [email protected]* The link to sign up:
https://listhost.uchicago.edu/mailman/listinfo/irbcontacts Subscribing to this list will allow you to receive periodic updates
from the BSD/UCH IRB office regarding new policies, new forms, meeting date changes, training information, and other IRB information.
*This is just for users (RT, PI) - NOT IRB members.
System Notifications
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System Notifications 28
AURA will normally send notifications when your action/attention is required You may click through this notification to access the
study’s workspace to perform the necessary review/endorsement/action
Check Junk mail and white-list the system email from AURA May want to set up a filter depending on your email volume
What email address will the AURA-IRB system notifications come from? [email protected]
Log into AURA-IRB Training Environment
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Log in 30
AURAIRB Environment:
aurairbtest.uchicago.edu/irbtrain2
Username: _mditka (Mike Ditka)
Password: aurairb2012