Slide Deck - AURA Project - University of Chicago
Slide Deck - AURA Project - University of Chicago
Slide Deck - AURA Project - University of Chicago
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1<br />
<strong>AURA</strong>-IRB<br />
Fundamentals
Agenda<br />
2<br />
• Introductions<br />
• Websites/Resources<br />
• Training Opportunities<br />
• Background<br />
• FAQs<br />
• Additional Benefits<br />
• Roles<br />
• <strong>AURA</strong> Help Desk<br />
• <strong>AURA</strong> Listserv<br />
• System Notifications<br />
• System Overview<br />
◦ Personal Workspace<br />
◦ Study Workspace<br />
◦ Smart Forms<br />
◦ Navigation<br />
◦ Activities
<strong>AURA</strong>-IRB Trainers<br />
Introductions<br />
3<br />
Candace Washington, cdwashington@uchicago.edu; 2-2925<br />
Steve Aldape, saldape@uchicago.edu; 4-2182<br />
Attendees<br />
Anything specific you are hoping to get out <strong>of</strong> today’s<br />
session<br />
Any questions you want to make sure are addressed<br />
before you leave
<strong>AURA</strong>-IRB Reporting<br />
4<br />
Questions about the data warehouse How to pull reports<br />
<strong>AURA</strong>-IRB Reporting Help Desk:<br />
auradw-help@lists.uchicago.edu<br />
Kim Griffin<br />
Senior BI Analyst<br />
Business Information Services/IT Services<br />
The <strong>University</strong> <strong>of</strong> <strong>Chicago</strong><br />
(773) 834-2653<br />
kgriffin@uchicago.edu<br />
David Weiland<br />
ITS/Business Information Services<br />
The <strong>University</strong> <strong>of</strong> <strong>Chicago</strong><br />
(773) 702-8931<br />
dweiland@uchicago.edu
Websites/Resources<br />
5
Websites/Resources<br />
6<br />
• <strong>AURA</strong> <strong>Project</strong> (http://aura.uchicago.edu)<br />
◦ Training Section<br />
http://aura.uchicago.edu/page/aura-irb-training<br />
◦ IRB Offices<br />
Links to each <strong>of</strong>fice on the <strong>AURA</strong> Homepage
7<br />
Training Opportunities
Training Opportunities<br />
• Initial Submission (IS) classes<br />
◦ Separated by type <strong>of</strong> research<br />
BSD- Drug/Device/UCMC Patients<br />
SBS & SAA - Surveys, Interviews, Focus Groups,<br />
Observational/Psychological Testing<br />
• <strong>AURA</strong> IRB - Additional Workflows (AM/CR/UP)<br />
◦ NOT separated by the type <strong>of</strong> research<br />
For all research types (BSD, SBS, SAA/Chapin Hall)<br />
• <strong>AURA</strong> IRB - Department Administrators<br />
8<br />
◦ Primarily for grants and contracts administrators who prepare<br />
funding proposals with human subjects.
Training Opportunities<br />
• Department specific sessions<br />
◦ As requested<br />
◦ As availability permits<br />
• One-to-one sessions<br />
◦ As requested<br />
◦ As availability permits<br />
9
10<br />
Background
Background<br />
• Huron Consulting Group / Huron Education<br />
◦ Offers a series <strong>of</strong> modules (Click Commerce)<br />
11<br />
We currently have deployed the Grants modules (<strong>AURA</strong>-Grants)<br />
<strong>AURA</strong>-IRB is currently rolling out April 2 nd<br />
<strong>AURA</strong>-COI will be the next module implemented<br />
Once stabilization occurs in all three module, a needs assessment<br />
can again be conducted and we can plan accordingly for the future.<br />
◦ These modules are highly customizable<br />
Future optimizations are already in the works for <strong>AURA</strong>-Grants<br />
These on-line systems will updated regularly
12<br />
FAQs
FAQs<br />
• Why are we moving to a new system We have<br />
IRB-Wise for the BSD and SBS after-all<br />
◦ IRB-Wise was a “home grown” solution<br />
It is not a sustainable solution<br />
No longer internally supported<br />
No plans for future updates<br />
13<br />
◦ The Huron/Click modules are an out <strong>of</strong> the box solution<br />
that is highly customizable<br />
Our own programmers/analysts work with the Click developers<br />
Modules are in many educational institutions across the country
FAQs<br />
14<br />
• One system for all Human Subjects researchers<br />
◦ BSD, SBS, SAA/Chapin Hall<br />
• Reduce the administrative burden on faculty and<br />
staff<br />
Only the questions that are applicable to your research protocol<br />
• Reduce the regulatory compliance risk for the<br />
<strong>University</strong><br />
◦ All IRBs are using the same set <strong>of</strong> questions/smart forms<br />
• Transparency for the research team<br />
◦ Can what state the study is in<br />
◦ Can see any history associated with the protocols
FAQs<br />
• How will the data from the current IRB-Wise<br />
system be imported into <strong>AURA</strong>-IRB<br />
◦ Conversion will be done electronically<br />
Manual corrections for converted data (as necessary)<br />
◦ Issues<br />
Smart form may reflect outdated version <strong>of</strong> study<br />
New questions – will not be answered<br />
◦ Legacy View<br />
For all converted records<br />
Can see the data from the original record in IRB-Wise<br />
Use to answer required fields in <strong>AURA</strong>-IRB<br />
15
Additional Benefits<br />
16
Additional Benefits<br />
17<br />
• Main Application always displays the current depiction<br />
<strong>of</strong> the study<br />
◦ Can view previous versions in the “snapshots”<br />
◦ Alleviate versioning issues<br />
• Question validation & “Hide/Show Errors”<br />
• COI & Training (HSP) Information tracked in system<br />
• Approved Documents in one place<br />
• Create study templates<br />
◦ PI/C0-Investigator lists<br />
◦ Standard language<br />
Recruitment<br />
Confidentiality precautions, etc.
Additional Benefits<br />
18<br />
• Reporting Capabilities<br />
◦ Department Administrators can request access to the<br />
data warehouse from their respective IRB <strong>of</strong>fice.<br />
◦ Pull pre-built reports or customize their own<br />
◦ The Reporting Team will be conducting trainings (dates<br />
to come).<br />
The reporting go-live dates is roughly two weeks after <strong>AURA</strong>-IRB<br />
goes live
19<br />
Roles
Roles<br />
• Your roles in <strong>AURA</strong>-IRB will be set-up for you<br />
◦ Registered User<br />
20<br />
Everyone who gets a paycheck from the <strong>University</strong> will have this<br />
role automatically<br />
You’ll be able to log into the system<br />
◦ Additional roles will be predetermined by the <strong>AURA</strong>-IRB<br />
Functional Team in conjunction with the appropriate IRB<br />
Director(s).<br />
◦ If you need additional roles/access in the system<br />
Email the <strong>AURA</strong> Help Desk and they will coordinate the proper<br />
addition/access accordingly
<strong>AURA</strong> Help Desk<br />
21
<strong>AURA</strong> Help Desk<br />
• <strong>AURA</strong> has dedicated support staff<br />
◦ Email <strong>AURA</strong>-Help@uchicago.edu for system related<br />
questions.<br />
22<br />
I can’t log in from <strong>of</strong>f campus. Help!<br />
I can’t find the study I started yesterday. Help!<br />
How do I add people to my research team<br />
How do I route a study to the IRB for review<br />
Where do I find my approval letter<br />
◦ You may also email non-system related questions and the HD<br />
will follow up with the appropriate parties and respond<br />
accordingly with the answer or your next steps for a solution.<br />
◦ If you would prefer to speak with a person, just send the HD a<br />
quick email that says, “Please call me @ 1-1234”
<strong>AURA</strong> Help Desk<br />
23<br />
• Please also continue to reach out to your normal<br />
channels <strong>of</strong> support<br />
◦ IRB Staff and Directors<br />
◦ Any other supporting <strong>of</strong>fice
24<br />
<strong>AURA</strong> Listserv
<strong>AURA</strong> Listserv<br />
25<br />
• Subscribe to the new <strong>AURA</strong>-IRB listerv: aurairb@lists.uchicago.edu<br />
◦ This listserv communicates important announcements to<br />
the IRB community.<br />
Training <strong>of</strong>ferings, help tips, system enhancements and other<br />
related information<br />
◦ The link to sign up:<br />
https://lists.uchicago.edu/web/info/aura-irb
<strong>AURA</strong> Listserv<br />
26<br />
• If you are in the BSD-IRB also subscribe to<br />
irbcontacts@lists.uchicago.edu*<br />
◦ The link to sign up:<br />
https://listhost.uchicago.edu/mailman/listinfo/irbcontac<br />
ts<br />
Subscribing to this list will allow you to receive periodic updates<br />
from the BSD/UCH IRB <strong>of</strong>fice regarding new policies, new forms,<br />
meeting date changes, training information, and other IRB<br />
information.<br />
*This is just for users (RT, PI) - NOT IRB members.
System Notifications<br />
27
System Notifications<br />
• <strong>AURA</strong> will normally send notifications when your<br />
action/attention is required<br />
◦ You may click through this notification to access the<br />
study’s workspace to perform the necessary<br />
review/endorsement/action<br />
◦ Check Junk mail and white-list the system email from<br />
<strong>AURA</strong><br />
May want to set up a filter depending on your email volume<br />
◦ What email address will the <strong>AURA</strong>-IRB system<br />
notifications come from<br />
_aura-irb@uchicago.edu<br />
28
29<br />
Log into <strong>AURA</strong>-IRB<br />
Training Environment
Log in<br />
30<br />
<strong>AURA</strong>-IRB Environment<br />
https://aurairbtrain.uchicago.edu/irbTrain<br />
BSD Research Team Member:<br />
_mditka<br />
Non-BSD Research Team Member: _ghalas<br />
Password for all users: aurairb2012
Additional Log-ins (BSD People)<br />
31<br />
Research Team member:<br />
Principal Investigator:<br />
IRB Staff:<br />
IRB Administrator:<br />
IRB Director:<br />
Designated Reviewer:<br />
_mditka<br />
_bguy<br />
_mjordan<br />
_jjackson<br />
_sbartman<br />
_jspringer<br />
Password for all users: aurairb2012
Additional Log-ins (Non-BSD People)<br />
32<br />
Research Team member:<br />
Principal Investigator:<br />
IRB Staff:<br />
IRB Administrator:<br />
IRB Director:<br />
Designated Reviewer:<br />
_ghalas<br />
_fwright<br />
_hcaray<br />
_spippen<br />
_rsanto<br />
_tskilling<br />
Password for all users: aurairb2012