Indiana University
Office of Research Compliance Newsletter 6th Edition
September 16, 2013
Kuali Coeus IRB
In this issue:
 
 
Life after Go-Live!!
NEWS FLASH

Since the release of Kuali Coeus (KC) IRB on August 19, we have had the following:

  • 550 unique users have accessed KC IRB
  • 375 new studies have been created/submitted in KC IRB
  • 689 Amendments, Renewals, and FYIs have been created in KC IRB
  • 39 training sessions conducted
  • 457 staff and faculty have been trained to use KC IRB
  • 48,526 distinct documents have been uploaded into KC IRB
 
 
Phase I – Run Down:

What went well in Phase I?

  1. Researchers were able to access the system with no or minimal difficulties.
  2. Researchers can successfully submit new studies and upload study documents to KC IRB.
  3. Information regarding CITI and COI completion was successfully integrated into KC IRB such that researchers could see immediately if these requirements had been completed by IU affiliated researchers and research staff.
  4. Researchers reported appreciating being able to update information, such as study contacts, on their own without having to notify the HSO to do so on their behalf.

What are we currently working on?

  1. Sporadic performance issues were encountered by both researchers and HSO staff. Specifically, the system experienced delays in opening tabs and uploading or viewing documents. These issues have been corrected.
  2. Researchers had difficulty accessing approved documents in the system following approval of a renewal or amendment. This issue has been corrected.
  3. We are working with several IU departments (UITS, Research Administration Systems & Decision Support, and Grant Services) to ensure that IRB information is linked with related grant and contract information in the KC system.
 
 
Phase II – What is Coming on November 11, 2013?

What will change?

  1. Researchers will use KC IRB, in lieu of email, for all IRB submissions including renewals, amendments and FYI’s.
  2. Researchers will have on-demand access to all current study documentation via KC IRB.
  3. The need to provide all study documents at the time of continuing review will be eliminated. Researchers will just perform a review of the study documents contained within KC IRB, confirm they are current, and submit.

What will NOT change?

  1. Researchers will continue to utilize the HSO website to obtain the required forms for IRB submissions, and will upload those completed forms to the KC IRB submission.
  2. Researchers will continue to receive notifications from the KC IRB system for submissions, approvals, and renewal notices.
  3. Training sessions, documentation, and assistance will continue to be widely available by visiting the HSO web page or contacting the HSO directly.
 
 
KC IRB Training will continue in September and October

There are a number of ways you can take advantage of KC IRB Training opportunities:

  • Face-to-face Training Sessions: Continue to be offered in Indianapolis and Bloomington. You will have the opportunity to learn from an experienced staff member and trainer to begin real, hands-on education about KC IRB with opportunities for Q&A.

    You can register for KC IRB training sessions at the KC IRB Training Sessions page. Be sure to choose a session entitled, ‘KC IRB – Intro to KC IRB – Submitting a New Study.’

  • Open Labs: Already attended a face-to-face session? Ready to submit your new study using KC IRB? Bring your study information and questions and sit down with an experienced HSO staff member in an open lab setting.

    Prior registration is appreciated; choose the sessions entitled ‘KC IRB Training – Help Session and Q&A’ at the KC IRB Training Sessions page.

  • eLearning Videos and Training Guides: In addition to live training sessions, a series of eLearning Videos and Training Guides are available on our website for you to review at the eLearning Videos and Training Guides page.

If you have any questions or need assistance registering for KC Training, contact us at kcirb@iu.edu.

 
 
KC IRB Tips
E-mail Preferences can be set to 'Immediate' for KC IRB Protocol Notifications

TIP To ensure that you receive prompt e-mail notification for your IRB submissions, click the link listed below to set your e-mail notifications to immediate only for these KC documents:
Workflow Preferences

Who can enter information, update the study, or sign in to view an item in KC IRB?

TIP Principal investigators (PIs), Co-PIs, and the person who created the protocol are automatically given permission to view information about the protocol, submit amendments and renewals for the protocol, request IRB actions, and receive IRB correspondence about the protocol. All other research personnel (key and non-key personnel) are given permission to view the protocol only. They cannot make submissions, request IRB actions, or receive IRB correspondence unless they are given specific permission to do so on the Permissions tab.

What if the attachment I need to add is not listed in the Attachment Type list?

TIP Most of the IRB forms and many of the attachments that are commonly used have been listed as individual types, so please review the list thoroughly. If you cannot find an attachment type that matches the document you need to upload, please use the attachment type of ‘Other’.

Help is just a phone call or e-mail away!

TIP Please be sure to look at the KC Support and Help information found on the ORA Website under Systems Toolbox: KC IRB.

 
 
Stay tuned. More to come in future KC IRB Newsletters!
 
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