Clinical Trials & Master Agreements
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Clinical Trial Agreements
In order to participate in an industry-sponsored clinical trial, an investigator must take many steps prior to enrollment of their first subject.
Feasibility and Budgetary
An investigator may choose a new study because the idea behind the study is interesting or the intervention will help patients live longer, healthier lives. 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 important 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; 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 clinical trials 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.
Should you need assistance in these areas, the Clinical Trials Unit (CTU) can help you determine the feasibility and the cost of conducting a particular trial.
Regulatory
Clinical trial research is subject to 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 or the University, 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 the 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 Corporate and Federal Contracting Services (CFCS) division within the Office of Sponsored Programs Administration (OSPA) handles industry-sponsored clinical trial agreements between the University of Louisville Research Foundation, Inc. (ULRF) (which executes contracts on behalf of the University) 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 the University and finally, the sponsor’s authorized representatives.
Clinical trials are often conducted at one or more of the university’s affiliated hospitals or facilities. The university is required to obtain appropriate legal approvals from the respective sites, which may include a letter of indemnification (LOI) or a facility use agreement (FUA). Your OSPA Contract Specialist facilitates the negotiation and execution of such agreements.
When the fully executed CTA (as well as any site agreements) is in place, and when IRB, IBC, and any other applicable approvals (including the hospital/facility) have been obtained, enrollment of subjects into the clinical trial may begin.
Master Agreements
The University of Louisville Research Foundation, Inc. (ULRF), on behalf of the University, has entered into master agreements with some of the larger sponsors of clinical trials, as well as master agreements with collaborative research networks and contract research organizations (CROs). These master contracts require less contract-negotiation time since the sponsor and ULRF have already agreed upon most terms and provisions; thus, only study-specific information, hospital agreements, and budget terms need to be finalized in order to initiate a new project.
If you have a question about a master agreement or would like to request that a master agreement with a particular sponsor be established, please contact the Office of Sponsored Programs Administration, Corporate and Federal Contracting Services.
View our current master agreements (sign in required).