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Indiana University
Office of Research Compliance Newsletter 9th Edition
January 27, 2014
Kuali Coeus IRB
In this issue:
 
 
Reflections on Phase II

Phase II of the KC IRB implementation allowed investigators to submit Amendments, Renewals, and Informational Items such as noncompliance and prompt reports via KC IRB. Here’s a recap of how things went:

  • Phase II implementation was a smooth transition from Phase I for investigators, the IRB, and the Human Subjects Office (HSO). This phase experienced no work stoppages or data corrections which impacted the research community.
  • The HSO assisted investigators with a number of issues, many of which included:
    • Searching for and locating a study or study submission
    • Managing attachments within the system
    • Understanding the Action List and resultant Notifications
    • Creating and submitting amendments, renewals, and general information items
  • Accordingly, the KC IRB team has responded with identifying additional functionality or training materials as outlined below.
 
 
KC IRB Enhanced Functionality

KC IRB has been recently enhanced with some additional functionality to allow easier study processing.

Function

Enhancement

Downloading study documents from the Notes & Attachments tabThe Notes & Attachments tab has been enhanced with a ‘Download All’ button. Study teams can click the ‘Download All’ button and each attachment will appear in a temporary folder. Previously, study teams had to download each document individually.
New or changed documents On the Notes & Attachments tab:
  • Study teams can now easily discern new or changed documents on the Notes & Attachments tab with new highlighting functionality. When adding or replacing a study document, the new or changed document appears with yellow highlighting.
On the Protocol Actions tab:
  • Navigating to Summary & History > Summary > Compare to Previous will display changed documents (those changed from the previous submission) in red font.
Navigating back to the ‘Base’ KC protocolKC IRB is now equipped with a ‘clickable’ protocol number in the header of protocol submissions. Specifically, when creating or manipulating a protocol submission (for example, a renewal):
  • In the header of the protocol submission, hover over the ‘Protocol #’ field
  • The base protocol number (the 10-digit number of the Main protocol) will turn red
  • Clicking on the base protocol number will return you to the base protocol.
 
 
What KC IRB Training Opportunities will be Available in 2014?

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

  1. Live trainings: Starting in 2014, live training sessions for KC IRB will be tailored to the user. The HSO plans to offer introductory sessions for the beginning user, as well as advanced sessions for the seasoned user. Training sessions will soon be available; you can register for KC IRB training sessions at the KC IRB Training Sessions page.
  2. Self-education: In addition to live training sessions, a series of training guides and eLearning videos will continue to be available on our website for you to review at the eLearning Videos and Training Guides page.
  3. Coming soon: Enhanced Online Help documentation will soon be available to guide you through the submission process without leaving KC IRB. Simply click on the question mark icon in the various KC IRB sections to obtain specific section-related assistance in completing the various KC IRB fields.

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

 
 
KC IRB Tips and Tricks

Please utilize the following tips and tricks to enhance your KC IRB experience:

• Utilize the asterisk (*)

TIP When conducting a search in KC IRB, utilizing the asterisk before and/or after your search criteria will widen the search criteria and will yield additional results. Additional help is available in the KC IRB Training Guide, How to Login and Search. If you can’t find what you’re looking for, please contact the HSO before re-creating the entry!

• Replace vs. Add

TIP When modifying an existing document on the Notes & Attachments tab, choose to Replace the existing document versus adding a new document, to avoid duplication.

• Save early and often

TIP Remember to click the Save button frequently when creating or modifying a KC IRB entry, especially when manipulating study documents on the Notes & Attachments tab. The HSO recommends saving after each upload to ensure documents are appropriately retained. Remember that you should receive the message: Document successfully saved after clicking the save button or navigating to another tab within the entry.

• Remember to Submit

TIP After creating a KC IRB entry, users must take the action to submit. Absent this step, the HSO is not notified of a new submission. If successfully submitted, Principal Investigators, Co-Principal Investigators, Study Managers / Correspondents, and Aggregators will each receive a notification of submission in his or her Action List. In addition, the individual taking the submit action should see the following message within the KC IRB entry: Document successfully submitted. If you don’t see this message, receive a notification, or if you’re not sure, don’t hesitate to contact the HSO for assistance.

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