Conducting Research at UofL
UofL is your go-to source for conducting research and clinical trials.
Whether you need to conduct social, behavioral, or educational
research or validate new medical innovations and treatments, we’re here to help.
We can help you with:
• Identifying principal investigators with particular research expertise and
interests;
• Obtaining general information about research resources, research
capabilities and sponsored research administration; and
• Streamlining communications among sponsor, research administrators,
PI and research personnel.
CLINICAL TRIALS
UofL offers a robust suite of specialized facilities and experts for conducting
clinical trials. The Clinical Trials Unit (CTU) is the central office that supports
and coordinates clinical trials. The CTU is the best point of contact for industry sponsors and can help navigate the contracting process, and work with our affiliated health system, UofL Health.
PROCESS
UofL has a formal feasibility process that takes place when all the necessary intake documents have been received:
- Notification of official site selection
- Finial Protocol
- ICF template
- Budget template
- Research agreement
- Manuals: Lab, Pharmacy, Imaging, and Device (if applicable)
If the applicable manuals are not ready at the time of submission, we request a provide time estimate of when the manuals will be available. These manuals will be required for facility approval.
It is also required that the sponsor complete a questionnaire through email to help us understand the expectations of the sponsor and the contracting requirements of the study following site selection. The feasibility/planning evaluation follow the receipt of the questionnaire.
The contracting process at University of Louisville can include private clinics and separate hospital entities depending on the needs of the project. The estimated timelines are:
- Outpatient study agreements – 30 to 90 days
- Inpatient study agreements – 60 to 120 days
UofL researchers often perform clinical trials at one or more third party hospitals or facilities. While affiliated with the university, each one is a separate legal entity. As such, these facilities typically require separate, direct agreements with the sponsor of the clinical trial. Therefore, for clinical trials that utilize third party facilities/services, the sponsor may be required to establish a separate agreement with the respective facility in addition to one with UofL.
However, in an effort to streamline the contracting process for multi-site clinical trials, UofL can offer the Accelerated Confidential Disclosure Agreement (ACDA) and to use the terms of the Accelerated Clinical Trial Agreement (ACTA) for industry-sponsored, multi-center clinical trials.
CTU has standard fees associated with clinical research administration. These fees are available here. The university’s facilities and administrative (F&A) charge for industry-sponsored clinical trials is 26%. All expenditures/expenses of the study are subject to these charges.
UofL allows the use of certain central IRBs as well as local IRB. Currently, the IRBs that can be utilized are:
- UofL IRB
- WIRB
- Advarra
- NCI IRB
- Other IRBs as needed.
IRB review fees are incurred for certain reviews. See all IRB information here.
The CTU utilizes Veeva SiteVault for Investigational Site File (ISF) management and sharing. All regulatory documentation will be easily reviewed through the eBinder tab. This is a very intuitive system that is easy to navigate. There are features to facilitate collaboration with the site/sponsor.
- Ability for monitors to upload documents directly
- Ability for sponsors to participate in document review workflows
- Ability for monitors to download documents in bulk
- Review and annotate documents such as budgets, contracts, and ICF versions
In addition, we have the ability to allow participant source review through the SiteVault system. In most cases, access to SiteVault can be gained within 72 hours. We still encourage remote access to the relevant EMR systems for Medical Records review as appropriate. The assigned clinical study coordinator will facilitate this process.