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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:

Quick Reference Information:

 

  • Legal Entity for sponsored activities:
  • University of Louisville Research Foundation, Inc. (ULRF)


  • Contacts for Research
    Agreements




  • Clinical Contracts Division
    501 E. Broadway, Suite 200
    Louisville, KY 40202-1798
    Phone: 502-852-8359
    Fax: 502-852-2590
                 Office of Industry Engagement
    (As of May 23, 2014)
    300 E. Market, Third Floor
    Louisville, KY 40202
    Phone: (502)-852-7253
    Fax: (502)-852-2590


    Authorized Signatory


    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:
  • Fringe Benefit Rates



  • Facilities and Administrative Cost Rates



  • Additional Details for Researchers:

     

  • Clinical Contracts Division
  • Additional details regarding the projects handled by the Clinical Contracts Division.


  • Office of Industry Engagement
  • Additional details regarding the process for projects handled by the Office of Industry Engagement.


  • Budget Revisions, Investigator Changes and End Date Extensions

  • 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.


  • Change in Status/Effort on Sponsored Projects
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