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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

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