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Indiana University
Office of Research Compliance Newsletter 13th Edition
August 25, 2014
Kuali Coeus IRB
Happy Birthday Kuali Coeus IRB!

Kuali Coeus IRB celebrated its first birthday on August 19, 2014!

Since the implementation of KC IRB in 2014, the IU implementation team has met several major milestones, as presented in the retrospective below.

Happy Birthday Kuali Coeus!
Looking back at our major milestones:
Retrospective on KC IRB Milestones and Respective Impact




August 19, 2013Phase I Implemented: KC IRB live for new studies

• Beginning with Phase I, all New Studies submissions are made via the KC IRB system.

November 11, 2013Phase II Implemented: KC IRB live for all submissions

• Researchers began utilizing the KC IRB system to submit all items to the HSO for review, including renewals, amendments, non-key personnel updates, and FYIs.

April 24, 2014Phase III Implemented: Smart forms live for exempt studies

• Exempt Research Checklist (ERC) was eliminated.

• The Questionnaire Tab introduced ‘smart-form’ functionality. All submission information for new exempt studies is now housed in the KC IRB system.

• The requirement to complete amendment forms for changes to exempt protocols was eliminated. Submission of amendments is still required per IU HSO guidance, but can be accomplished within KC itself.

July 31, 2014Phase IV Implemented: Smart forms implemented for all new studies, amendments, and renewals

• Forms for new expedited and full Board studies, as well as Amendments, Renewals, deferral requests, and Humanitarian use Device (HUD) applications were eliminated.

• The Questionnaire Tab introduced ‘smart-form’ functionality. All submission information for the above submissions are now housed in the KC IRB system.

• A new pre-review process was initiated so that all pre-review comments and revisions are now communicated via KC IRB.

• The HSO website was reorganized and streamlined to provide:

• Step-by-step instructions;

• A new decision-making tool to help investigators determine the appropriate level of review;

• Updated guidance page with new content.

For more information about Phase IV, see the July announcement.

Thank you to all involved in making this a productive and successful first year!!
Stay tuned…..more to come!

For more information about KC IRB, visit the newly-redesigned HSO website or contact an HSO staff member directly.

Copyright © 2014, The Trustees of Indiana University