The Lifecycle of an IRB Protocol in KC

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Dec 2, 2013 (3 years and 11 months ago)

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open source administration software for education

research administration

The Lifecycle of an IRB Protocol in KC

Joseph Abraham,
Cornell University

Dan Dwyer, Cornell University

Weiwen Sung, Iowa State University

open source administration software for education

Session Agenda

The Lifecycle of an Institutional Review Board
(IRB) Protocol in
Kuali

Coeus

(KC)


Kuali Coeus Overview


IRB Functionality


Demonstration


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Why an electronic system?


Efficiency


Eliminate paper, distribution processes


Conserve resources


Staff and Researcher time, money saved


Standardize processes


Integration with other systems


Gather data for information delivery and
reporting

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Why
Kuali

Coeus
?


Functionally equivalent with Coeus
-

initially
developed by MIT and implemented by over 40
institutions


A common interface and user experience across
all research administration systems


Open source solution reduces licensing costs


Kuali Coeus Community
-

Power
of national
consortium for support, enhancements and
subject matter expertise



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Kuali Coeus IRB Functionality

1.
Submission

of protocols to the IRB administrative office

2.
Assignment

of protocols to an IRB and specific reviewers

3.
Development of IRB
agenda

4.
Review

of the protocols by IRB

5.
Correspondence

generation

6.
Electronic creation of
minutes

7.
Responses

from researcher

8.
Protocol management
actions by IRB administrator

9.
Issue
approval notices

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Kuali Coeus IRB Interface


Portal interface to present common actions
based on role


Consistent interface for navigating through
document and entering data across all
research administration modules


Dynamic list of actions drive by role and
current state of protocol


Local
configuration without customization


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Demonstration

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Process Map

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1.
Create
a Protocol &

Submit

2.
Receive
Protocol
&
Assign
for Review

3.
Online Review

4.
Record
Committee
Decision and Approval

5.
Submit
Amendment for
Expedited Review

6.
Request
Specific Minor
Revisions


7.
Resubmit Amendment
with Revisions

8.
Approve Amendment
with Revisions

9.
Notify IRB
(w/
attachment)

10.
Acknowledge

11.
Renewal

12.
Approve Renewal


13.
Expire Protocol

14.
Review Summary &

History


Demonstration Steps

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Researcher: Create Protocol


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Researcher: Enter Protocol Data


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Researcher: Submit Protocol


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Admin: Lookup Submissions


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Admin: Committee and Agenda


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Admin: Assign Reviewer


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Reviewer: Search All My Reviewers


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Reviewer: Enter Review Comment


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A
dmin: manage review comment &
committee decision


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Admin: Modify Minutes


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Admin: Generate Minutes


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Reviewer: View Minutes


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Researcher: Create Amendment


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Researcher: Change Title


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Researcher:
Submit Amendment


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Admin: Return for Minor Revisions


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Researcher: Submit with Revisions


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Admin: Expedited Approval


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Researcher: Notify IRB


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Admin: Acknowledge Notification


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Researcher: Create Renewal


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Researcher: Submit Renewal


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Admin: Approve Renewal


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Admin: Expire Protocol


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Researcher: View History


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Kuali Coeus IRB References



Kuali Coeus Information


http://www.kuali.org/kc/overview


Test Drive


http
://www.kuali.org/test
-
drives