Quick Start Guide: Approvew View in Kuali Coeus: Proposal Development Document
Modified for Accessibility: 5/8/17
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Q U I C K S T A R T G U I
D E
Kuali Coeus:
The Clinical Trial Process
Industry/Commercial Clinical Trials at Indiana University
Industry/Commercial clinical trials are routed to the Office of Clinical Research (OCR) while clinical trials
supported by federal funds or foundations/non-profits are routed to the Office of Research Administration (ORA).
Both types use the Kuali Coeus routing and awards systems. Correctly completing the forms ensures the
documents reach the correct office. The system looks at three variables to determine where it routes; the Clinical
Trials Checkbox, the Sponsor field, and the Prime Sponsor field.
For more complete information on completing and submitting a Kuali Coeus Proposal Development Document,
please see the documentation How to Submit a Proposal. For more information about industry/commercially
sponsored clinical trials, contact the Office of Clinical Research:
OCR@iu.edu.
Variable 1: The Clinical Trial Checkbox:
The Proposal Development document opens to the Proposal tab which contains the required items for saving the form.
The clinical trials checkbox is located on the Institutional Fields Conditionally Required subpanel. A clinical trial is generally a project
which involves testing of a sponsor’s device or drug on participants. The checkbox should be checked if the project is a clinical trial
regardless of funding source. Additionally, variables 2 or 3 are needed for the document to route to OCR.
Variable 2: The Sponsor
In addition to the Clinical Trial Checkbox being marked, if the Sponsor is an industry/commerical entity and no federal funds are
involved, the document will route to OCR. If the Sponsor is NOT an industry/commericial entity (example below), the document could still
route to OCR if Variable 3 is met.
Variable 3: The Prime Sponsor
In addition to the Clinical Trial Checkbox being marked, if the Prime Sponsor is an industry/commerical entity and no federal funds are
involved, the document will route to OCR. If the Prime Sponsor is NOT an industry/commercial entity (example below), the document will
route to ORA.
Last Modified: September 1, 2021
