AURA-IRB

March 23, 2018 update: The AURA-IRB system was updated on March 23 with the following changes:

1)   New protocol smartform version is now version 3. Version 3 includes an additional view on research results (view 6.3) for applicable studies. Any new submissions that are created in the system PRIOR to 7:00 pm on Friday, March 23 will be retained in version 2 of the AURA-IRB smart form. New submissions created after 11:00 pm on Friday, March 23 will utilize the new version of the smart form.

2)   Display on the main screen for each protocol has been modified to show additional study details and to group study details into boxes.

3) Display on the main screen has been changed to more easily show when a study has been approved by the IRB with stipulation(s); this field can be updated by the IRB office throughout the life of the study as stipulations are imposed or removed.

4)  Other changes were made in preparation for revised Common Rule regulations. Please note that the revised Common Rule is not yet in effect and no changes affecting users were implemented with respect to the revised Common Rule with this AURA-IRB version.

If you have any questions regarding the new form, or IRB processes in general, please contact the IRB offices at 773-702-6505.

Email sent 3/26/18: Email to research community

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November 3 update: The new protocol submission smartform in AURA-IRB has been revised in order to streamline the form and take advantage of system functionalities. AURA-IRB will be offline from 6-9 PM on Thursday, November 3, 2016 in order to implement this change. As of November 4, new submissions begun in AURA-IRB will use the new form.

Changes to expect:

1) Sections are renumbered
2) Questions are “hidden” or “shown” based on responses to previous questions on the screen
3) Addition of a field to identify the “Study Coordinator” (EPIC purposes)
4) Ability to upload grant application directly into the form (without performing additional activity)
5) Study activities are now specified in one section (as opposed to primary and secondary activities). Please ensure all activities to be conducted are listed in View 2.2, including medical record review, as needed.
6) Simplification of “Costs” questions
7) Expanded section to clarify measures to protect confidentiality of records

Please note – Any new submissions that are created in the system PRIOR to 6:00 pm on Thursday, November 3rd will retain the current version of the AURA-IRB smart form. New submissions created after 9:00 pm on Thursday, November 3rd will utilize the new version of the smart form.

The amendment and continuing review forms have not been revised at this time. Changes may be forthcoming.

If you have any questions regarding the new form, or IRB processes in general, please contact the IRB offices at 773-702-6505.

Email sent 11/2/2016: Email to research community

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Please see the AURA page to access AURA IRB: http://aura.uchicago.edu/

If you have an active CNet or UCHAD account, you will be able to log in to AURA IRB. No account activation is required. You must be onsite OR logged on to the University of Chicago network in order to access the AURA website.

 

Previous communications regarding the AURA transition:

As of April 2, 2012, all IRB submissions should be completed in AURA-IRB. IRBWise was the IRB electronic submission and review system from 2009 to March 2012. As of March 16, 2012, IRBWise will no longer be accepting new submissions in IRBWise. The University has transitioned to AURA-IRB as the electronic IRB system.

Click here for a memo regarding numbering of amendments for existing protocols in IRBWise. Amendments in AURA will continue the numbering used in IRBWise.

Please use these links for more information on the following topics.

_____ Background -- Implementation -- Converted data -- AURA FAQs

 

Background on the transition to an electronic system

With the advent of the NIH grant online submission process and in keeping with the decisions made by peer institutions, the BSD/UCMC IRBs implemented an online submission and review system for IRB submissions (IRBWise). As of 2012, the University has implemented a University-wide submission and review system (AURA-IRB). The online submission system is designed to ease workflow and allow investigators to more easily track their protocols, amendments, and other submissions. Systems have been customized according to our institution’s policies and procedures.

Instead of filling out forms, signing them, and physically submitting them to the IRB office, investigators and research staff will login to the secure website, enter submission details, upload any pertinent documentation, and electronically send each submission to the IRB. 

Once logged in, researchers may view the current status of their protocols and full details of their submission. Researchers may access all documents previously uploaded as part of their submission. In addition, co-investigators and research staff listed on an approved protocol have access to approved documentation, including consent forms and approval letters. Investigators have access to the system and all of their approval letters, documents, and submissions contained therein from any computer on the secure University of Chicago network, 24 hours a day, 7 days a week.

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Implementation History

IRBWise:

New Protocols: Beginning May 1, 2009, all submittors may begin submitting online. All protocols submitted to the IRB on or after July 1, 2009 were submitted in IRBWise.

Continuing Reviews: Currently-approved IRB protocols were rolled into the online system as they come up for renewal. All renewals submitted for protocols expiring on or after October 1, 2009 were submitted in IRBWise.

Other submissions: Once a protocol is approved online, subsequent submissions for that protocol, including amendments, renewals, and adverse events, will also be submitted online.

AURA:

Data on all approved protocols were converted from IRBWise into AURA. As of April 2, 2012, investigators can submit new protocols, as well as amendments and renewals on existing approved protocols, in AURA. Researchers no longer have access to IRBWise.

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Converted Data

* How to find LETTERS

Letters from IRBWise should be accessible either through the “Printer Version” or in the smart form on view 18.1. They are under the “Legacy Activity History” (the IRBWise history).  

 

* How to find DOCUMENTS

The approved consent form will be in the “All Documents” tab on the main protocol view, along with all other approved documents. Once any consent forms are stamped in AURA, they will then appear in the “Stamped Documents” tab.

The documents in “All Documents” are approved (even though the tab is not labeled “Approved”); the “Stamped Documents” tab is for stamped approved documents. This will only include advertisements and consent forms in AURA.

 

* How to find previous CRs, AMs, UPs

Continuing Reviews, Amendments, and UPs submitted in AURA will be stored under the appropriately named tab in the protocol workspace. However, data converted from IRBWise did not covert into these tabs. Previous submissions from IRBWise can be viewed through the “Legacy Activity History” as noted above.

Submissions in AURA will, however, retain the numbering from IRBWise. If a protocol had 5 amendments approved in IRBWise, the next amendment in AURA will be labeled as amendment #6.

 

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AURA FAQs

 

(1) Why aren’t the study personnel I want to add to my protocol in the list of available personnel in IRBWise?

Personnel accounts in AURA are based off of the University’s CNet and UCHAD accounts. If the person in question should have a CNet account, but has not activated it or it is not valid (see below), he or she will not be listed in the available personnel list.

If someone is not listed in AURA, and you believe the person should be listed, please contact the AURA Help Desk by sending an email to: aura-help@uchicago.edu

(2) How do I check on a CNet ID?

(1) Ask the person to check that he or she has “claimed” his/her CNet account. This can be done from this webpage: https://uchicago.service-now.com/it

(2) If the person has an active UCHAD or CNet account but he or she is not listed in AURA, the account may not conform to current CNet account naming practices, in which case the person will need to change his/her CNet ID. Please ask the person to call the CBIS Service Desk to ask that the name of the account be changed.

Once the account has been corrected, the person’s name should appear in the list of available personnel in AURA.

(3) How does a new user get permission to login to AURA?

If a new user has a CNet or UCHAD account, they will automatically be able to log in to AURA using that account.

(4) Why can't I access the AURA log in website?

Users must be using the University of Chicago secure network or a web proxy in order to access the login page. If you are onsite at the U of C, your computer should already be connected to the secure network. If you are offsite, you will either need to log on to the secure network or use the web proxy in order to log in to AURA.

To log on to the secure network, you will need to download a program to your computer which will allow you to acces the secure network using the VPN. For more information on this process, please see the ITS website at https://uchicago.service-now.com/it . Once you are connected to the vpn, you can log in to AURA using the "AURA IRB Login" link on the AURA page.

If you wish to login using the web proxy, choose "AURA IRB Login" on the AURA page. You will be directed to a log in screen and then redirected to AURA.

(5) Who has access to my submission?

Each member of the research team listed on the submission may login and view, edit submissions in process, and print documents from the submission. The OCR staff and IRB members may view all submissions, although access to review comments may be blocked.

Additionally, certain designated administrators in your department and/or section, including the section administrator, department chair, and/or grants administrator, may have view-only access to all submissions in that department and/or section.

Unlike in IRBWise, in AURA, any one who will edit a submission or enter a submission will need to be listed as a member of the research team, including administrative personnel not otherwise involved in the research project. An amendment is needed to add someone to the research team.

(6) I am not able to open a document on my existing study in AURA. I get an error message when I click on the document. Why can't I open this document?

AURA does not allow special characters in document names. When submitting a new document, please do not use special characters (*&^ etc.) in the name of the document. The file name should only include aplha numeric characters, spaces, dashes (-), or underscores (_).

If you are not able to open an existing document on a submission that has already been approved, please contact the AURA Help Desk by sending an email to aura-help@uchicago.edu . The AURA Help team should be able to rename the document so that it can be opened.