Indiana University
Office of Research Compliance Newsletter 3rd Edition
June 17, 2013
Kuali Coeus IRB
In this issue:
 
 
KC IRB Training Starts July 22, 2013!

KC IRB training for the Research Community is scheduled to begin July 22, 2013 - it’s just around the corner! You can register for training at the following link:

Kuali Coeus Compliance Training Sessions

The KC IRB training curriculum is comprised of five (5) modules with separate courses in each module. While scheduled for three hours, each module should take no longer than two hours to complete. Depending on your role and level of involvement in the ‘nuts-and-bolts’ of dealing with the IRB, there will be suggested modules for you to complete. If, for example, you are solely responsible for everything pertaining to regulatory maintenance (i.e., a Principal Investigator with no Coordinator support, or a Coordinator supporting a PI), you may want to take all five modules. The modules and courses are:

Course #

KC IRB Training Module

Course Content

101

Introduction to KC IRB

• Human Subjects Office (HSO) Overview

• The KC IRB System

• Getting Started: Accessing and Navigating the System

• Protocol eDoc Overview

201

Creating and Submitting a New Study

• Creating a Submission

• The Personnel Tab

• The Questionnaire

• Protocol Actions

• Funding Source

• Submitting for Review

301

Responding to IRB Review

• Action Lists: Filtering and Prioritizing

• Routing

• Processing the Submission

401

Post-Approval Study Actions

• Amendments

• Renewals

• FYIs

• Request to close or re-open enrollment

• Updating Investigators

501

Maintenance and Help

• Where are my documents?

• Printing my documents and study information

• I found a mistake - - now what?

• Checking the status of submissions

More details about suggested KC IRB Training Course combinations will appear on the registration page (linked above), so please check back frequently.

 
 
KC IRB eLearning Videos are on Their Way!

For a quick reference or as a training refresher, KC IRB video segments are currently in production. As of now, two (2) are completed and ready for viewing:

  1. KC IRB Introduction
  2. Submitting a New Study – Exempt

In the weeks to come, more videos will be produced and accessible for viewing. The first group will be related to Phase I – the use of KC IRB for New Studies. These will include how to submit new full board, expedited, NIH CIRB/WIRB, and student project studies. More eLearning videos relevant to each specific Phase (I-V) will be produced and available by the time of that Phases’ implementation.

KC IRB eLearning videos are available at the following link:

Kuali Coeus - IRB eLearning Videos & Training Guides

Or, you can also access KC IRB specific information from the KC IRB tab on the Human Subjects Office page, located at the following link:

KC IRB Implementation

 
 
New Tools Available in KC IRB

With the introduction of KC IRB, researchers will have some new tools available to assist in the development, submission and management of the vast array of documents involved in human subjects’ research. For example, the KC IRB system provides new resources for document and version control. Through the KC IRB system’s document sharing capability, and ability to incorporate multiple users, we anticipate this may facilitate team research efforts. Additional new tools include:

  • Researchers will have immediate on-line access to current approved study documents
  • Because multiple users can access the system and study documents concurrently, KC IRB enhances collaboration in the preparation and revision of documents and submissions
  • KC IRB easily accommodates your work schedule, permitting the individual researcher and research teams to easily stop and go – to save your work and come back to it later.
  • KC IRB will be available 24x7!
 
 
KC IRB Training Opportunities Available for YOU

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

  1. Starting July 22, 2013, live training sessions for KC IRB will be offered in Indianapolis and Bloomington. You will have the opportunity sit down with 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 following link: Kuali Coeus Compliance Training Sessions
  2. In addition to live training sessions, a series of eLearning videos will be available on our website for you to review at the following link: Kuali Coeus - IRB eLearning Videos & Training Guides

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

 
 
Volunteer for KC IRB Model Office

KC IRB Model Office is a test environment in which you can view and play in the system prior to implementation. In a sense, it is way to ‘kick-the-tires’ and get familiar with the application prior to actually submitting IRB protocols. Participation is voluntary! If you are interested in volunteering for KC IRB Model Office activities, please contact us at kcirb@iu.edu.

 
 
New KC IRB Questions and Answers Added to the FAQ Site

The Office of Research Administration hosts a FAQ (Frequently Asked Questions) site at the following link: Kuali Coeus (KC) Compliance Questions. We are populating KC IRB related FAQs on this site.

Check out the FAQs to learn more about KC IRB!

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