Industry-Sponsored Clinical Trial for Review

A clinical trial agreement (CTA) between ULRF and an industry sponsor establishes the contractual terms and conditions for conducting a specific clinical trial. To establish a CTA, please forward the following documents to CCD.

    • Clinical trial agreement (either sponsor’s contract or ULRF template)
    • Protocol
    • Part A TRIA (Transmit for Review and Initial Assessment)

    • If available:

    • Draft budget
    • Informed Consent & Research Authorization (HIPAA) Form

Your contract specialist will use these documents to begin negotiating an agreement with the sponsor. A signed Part B MIRA (which includes essential study details, acknowledgement of participant responsibilities and commitment of departmental resources) must be received by the CCD prior to contract execution.

CCD has prepared these instructions to guide UofL faculty/staff investigators through the steps required for processing agreements and awards received from industry sponsors. If, however, your project is one that you have developed (an "investigator-initiated" project) and involves existing university intellectual property, it may require input from UofL's Office of Technology Transfer (OTT). Your CCD contract specialist will bring OTT into discussions as needed.