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Clinical Research Division Submission Procedures

The clinical trial process flow graph shows the typical process and submission flow for a clincial trial at UofL. Frequently the sponsor will require the investigator (and/or UofL/ULRF) to sign a non-disclosure or confidentiality agreement (NDA) before sending the protocol for review. The Clinical Research Division (CRD) uses the NDA Review form to request the review of the NDA for institutional signature or changes recommended prior to an invesigator signing individually - not binding upon the institution. The TRIA form provides early review (normally prior to the budget being finalized) of the Clinical Trial Agreement (CTA) provided by the sponsor. The CRD negotiators work with Sponsor representatives to revise the sponsor CTA to be in conformity with University policy and the laws of the Commonwealth of Kentucky. This process (as the graph shows) is conducted in parallel with budget finalization by the department to minimize processing delays. The MIRA is typically used after the budget is finalized and the IRB submission packet is completed. Enrollment of human subjects cannot begin until after IRB approval, CTA execution and hospital facility approval(s) if the study will be conducted at or using resoruces or services of a separate healthcare organization such as one of the Louisville Medical Center hospitals.

Clinical Trial Process Flow Graph (PDF)

 


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