Information for Researchers
The Clinical Contracts Division (CCD) focuses on clinical trials and clinical research/clinical activities (generally research or sponsored activities that would require review or approval by the Institutional Review Board (IRB)) sponsored by industry or involving one of the hospitals in the Louisville Medical Center.
The Office of Industry Engagement (OIE) focuses on projects with industry that would not involve human subjects that would require review or approval by the IRB.
If you would like to meet with us about your sponsored project we will be happy to arrange a meeting to discuss your project and/or answer questions about the process; possible policy, contractual, compliance or regulatory issues; budget development including the appropriate Facilities & Administrative (F&A) rates; subcontracts/subawards.
Where to Begin
Per University policy, any sponsored activity must be cleared/reviewed by either the Office of Sponsored Programs Administration - Grants Division, the Clinical Contracts Division, or the Office of Industry Engagement. You should have the appropriate office review your proposal/planned sponsored activity prior to sharing it with a prospective sponsor. It is much easier to correct/revise items (e.g. something that would not be in conformity with University policies and procedures) prior to sharing it with the prospective sponsor.
Clinical Contracts Division (CCD) and Office of Industry Engagement (OIE) have responsibility for the review/clearance of the following projects when sponsored or funded by for-profit/industry entities:
1. CCD: The project is a clinical trial using the operational definition of clinical trial for the purpose of proposal submission
2. CCD: The project involves one or more of our affiliated hospital sites (Norton Healthcare, Jewish & St. Mary’s, University Hospital, VAMC) or other external healthcare provider
3. OIE: The project involves a small business or other for-profit entity with a governmental flow-through such as the SBIR/STTR or KSTC programs where the business will contract with the University (not the University contracting with the governmental agency)
To submit a project for review/clearance, please use the appropriate form for the project:
• To submit a project that is a proposal for potential funding such as a typical grant submission to a federal agency, use the Proposal Clearance Form (Word).
• To submit a clinical trial agreement for review or a project involving an affiliated hospital or external healthcare provider, use the Transmit for Initial Review and Assessment (TRIA) form to start the review process. A completed Multi Institutional Research Application (MIRA) form is required prior to contract signing. (See Clinical Contracts Division – Information for Researchers for details.)
•To submit a nonclinical project, use the Proposal Clearance Form (Word) . (See Office of Industry Engagement – Information for Researchers for details.)
• To have a nondisclosure agreement (NDA) (also called a Confidentiality Agreement) reviewed, use the NDA Review Form.
Quick Reference Information:
|University of Louisville Research Foundation, Inc. (ULRF)|
|Clinical Contracts Division
501 E. Broadway, Suite 200
Louisville, KY 40202-1798
|Office of Industry Engagement
(As of May 23, 2014)
300 E. Market, Third Floor
Louisville, KY 40202
||Only a Research Administration representative with signatory authority is authorized to sign on behalf of ULRF/UofL for sponsored activities. Investigators and department heads are not authorized signatories.|
|Use the following in developing your budget:|
Additional Details for Researchers:
|Additional details regarding the projects handled by the Clinical Contracts Division.|
|Additional details regarding the process for projects handled by the Office of Industry Engagement.|
|Use the "Request to Revise Chartfield for Existing Clinical Trial Study/Industry Sponsored Projects" Excel form to make changes for a chartfield previously established. This form is used to initiate budget changes (e.g. increases, decreases, changes between budget categories), investigator changes (including RIF revisions) and End Date Extensions. Note: Approval from the sponsor may be required for some changes to be processed.|