Indiana University
Office of Research Compliance Newsletter 1st Edition
April 15, 2013
Kuali Coeus IRB
 
In this issue:
 
 
What is Kuali Coeus IRB?

KC IRB is a web-based system for the submission, processing, and review of human subjects research studies. The Kuali Coeus system is an electronic research administration system currently serving the needs of researchers and staff at Indiana University in areas associated with proposal submission and award management. With the addition of the KC IRB module the electronic submission, processing, and review of IRB protocols will be possible thus enhancing efficiency for researchers, reviewers, and the HRPP (Human Research Protection Program) staff. The move to KC IRB will, as well, permit researchers and staff to link IRB submissions to other modules such as KC proposal development and award.

The adoption of KC IRB will:

  • Allow researchers the ability to create, amend, and renew IRB studies for review and approval via the web;
  • Enable researchers to track the status of studies as they move through the review processes;
  • Give IRB Committee members the ability to electronically access, review, comment on, and approve studies;
  • Afford HRPP staff the ability to accept, process and route studies through the system, support IRB Committee members and IRB Committee meetings and;
  • Help academic unit compliance administrators monitor human subjects research approvals within their school, department or program.
 
 
What does KC IRB mean for me?

KC IRB will enhance your IRB study submission and tracking experience in a series of phases, eventually resulting in a fully web-based process.

Phase I - New Studies

Implementation - Summer 2013

In this first phase, researchers will begin submitting new studies via the KC IRB system:

  • Email submissions of new studies will be eliminated
  • Information will be input into KC IRB thus eliminating several current IRB forms
  • Remaining forms will be uploaded to the KC IRB system

Phase II - Ongoing study actions

Implementation - Fall 2013

The second phase of the implementation will allow researchers to submit all study actions, including continuing reviews, amendments, and general information items, via the KC IRB system:

  • All study submissions will be submitted through KC IRB; submission by email will be completely eliminated
  • Researchers will have on-demand access to all current study documentation

Phase III - Communications and workflow

Implementation - Winter 2013

In the third phase, through enhanced workflow programming in the system, communication between researchers and HSO will flow through KC IRB rather than via email. The system will be equipped with detailed submission status information which will generate an alert to researchers that an action has been taken in the system:

  • KC IRB rather than emails will be used for study specific communications between researchers and HSO during the review process
  • Enhanced system logic will move submissions through the business process in a streamlined fashion

Phase IV - Online IRB member review

Implementation - Spring 2014

This fourth phase of implementation allows IRB members to perform reviews of study submissions within the KC IRB system:

  • Study submission approvals will be immediately available to investigators
  • Researchers will experience real-time status updates

Phase V - Smart-form questionnaires

Implementation - Summer 2014

In this phase, the system will be enhanced with a fully web-based submission process with ‘smart’ technology, including branching logic:

  • IRB forms will be eliminated and replaced with web-based questionnaires
  • Questionnaire branching logic will eliminate questions not applicable to the submission
  • Improved ability to generate detailed metrics and historical data tracking/trending due to supplemental information captured within the system

Phase VI - FDA 21 CFR Part 11 compliance

Implementation - TBD

The final phase of the KC IRB implementation involves making the system Part 11 compliant:

  • The Human Subjects Office paper files are eliminated
  • Researchers may signify to sponsors and funders that the IU IRBs have a Part 11-compliant submission and tracking system
 
 
Upcoming Campus KC IRB Town Halls

You are invited to join us for a series of KC IRB Town Halls starting in May 2013. Please come and learn about KC IRB, ask questions, and make suggestions.

For more information and to register, please visit http://researchadmin.iu.edu/Systems/KC/Training/kctrain_comp.html to sign up!

 
 
Model office participation

To volunteer for testing and quality assurance activities for KC-IRB please contact us at: kcirb@iu.edu

 
 

Stay tuned. More to come in future newsletters...

 
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