Clinical Trial Agreement

When an investigator wishes to participate in an industry-sponsored clinical trial, preparation must be made on several fronts.

Feasibility and Budgetary

An investigator may choose a new study because the idea behind the study is interesting or because the per-patient compensation seems attractive. However, to successfully attain (or surpass) enrollment goals and to maximize the efficient use of valuable time and effort associated with screening, treatment, data collection and reporting requirements, it is advisable to objectively assess the feasibility of a particular study to succeed within the context of the investigator's current clinical environment. Determining clinical trial feasibility is one of the first steps in clinical trial conduct. The possibility of conducting a particular project is evaluated in light of the overall objective of optimum project completion in terms of timelines, targets and cost.

To properly develop budgets for research projects it is important to assess protocol feasibility and identify the costs to conduct the study. A study should not be pursued if it does not cover the costs to conduct it, unless there are additional financial resources identified.

The Clinical Trials Unit (CTU) can assist you in determining the feasibility and the cost of conducting a particular trial.

Regulatory

Clinical trial research is subject to a number of federal and state laws and regulations. In addition, sponsors have their own requirements through contracts and protocol designs that require investigators to comply with certain expectations in conducting clinical trials. The failure to achieve compliance can have many consequences, including federal exclusions or debarment of individual investigators, civil monetary penalties, and, in some instances, the application of criminal law.

• Contact the Human Subjects Protection Program Office for Institutional Review Board (IRB) information and regulations.
• Contact Clinical Trials Unit (CTU) for IRB submission support.
• Contact the Institutional Biosafety Committee (IBC) for information and regulations on the use of biohazardous agents and recombinant and synthetic nucleic acid molecules.

Contractual

The Clinical Contracts Division (CCD) handles legal agreements between the University of Louisville Research Foundation, Inc. (ULRF) and the nongovernmental sponsors who fund our clinical trials. Your contract specialist negotiates the clinical trial agreement (CTA) terms and conditions, then obtains the signatures of the principal investigator and UofL’s and the sponsor’s authorized representatives.

Clinical trials are often conducted at one or more of the university’s affiliated hospitals or facilities. The university obtains the appropriate legal approvals from the respective sites, which may include a letter of indemnification (LOI) or a facility use agreement (FUA). Your contract specialist facilitates the negotiation and execution of such agreements.

When the fully executed CTA as well as any site agreements are in place, and when IRB, IBC and any other applicable approvals have been obtained, enrollment of subjects into the clinical trial may begin.

I Want To Submit: Industry-Sponsored Clinical Trial for Review