Start-Up and Maintenance Fee Explanation
Depending on the scope and design of a given study, certain fees may be required by the University. Below is an explanation of these fees
The sponsor pays the institution a non-refundable administrative start-up fee. This fee covers the cost of reviewing the protocol and determining study feasibility at our site, preparing and submitting regulatory documents and required documentation to the IRB, preparing the coverage analysis and budget, and attending the site initiation visit. This fee is due upon contract execution and receipt of invoice.
The sponsor pays for local IRB review of all regulatory documents. This fee is payable upon review and receipt of invoice: it is not contingent upon IRB approval. This includes an initial review fee and continuing annual review fees. For more information, please visit: http://louisville.edu/research/humansubjects/about-the-irb
If the study is conducted in locations outside UofL space, additional fees will be applicable. These include standard fees charged by the affiliated hospitals. If an affiliate pharmacy will be utilized, pharmacy fees will also apply.
The sponsor pays the institution a non-refundable CTMS set-up fee. This fee covers the cost of building the study in the university’s CTMS system.
In order to improve study start-up timelines, centralize, standardize and optimize regulatory documents and processes, we are using an e-regulatory system. Sponsors have direct access to the investigative site file (ISF). The sponsor pays an annual fee for the utilization of the e-regulatory system. The initial fee is payable upon contract execution, and annually thereafter.
The sponsor pays the institution a non-refundable administrative fee annually for the length of the study, beginning one year after contract execution and until IRB closure. This fee covers the cost of annual IRB renewals and required regular maintenance such as safety reports, site-required IRB submissions, CTMS maintenance, reporting for billing compliance, etc.
The sponsor pays the institution a regulatory amendment fee for each sponsor-required IRB submission. This fee covers the cost of preparing and submitting sponsor-required IRB submissions such as protocol amendments, ICF changes, new Investigator Brochures, new recruitment materials, etc.
The sponsor pays the institution a financial amendment fee for each contract amendment. This fee covers the cost of reviewing and finalizing contract amendments.
The sponsor pays the institution a quarterly fee for pre-screening. This fee is only requested if applicable to the study and covers the cost of reviewing medical records for potential eligible subjects.
The sponsor covers additional training costs for all personnel on the DOA or 1572 if training is required through a sponsor system. This is an hourly fee and the amount invoiced will be based on the time spent to complete the training.
The sponsor covers costs related to an FDA or sponsor audit. This is a per-day fee and the amount invoiced will be based on the time spent to complete the audit.
The sponsor pays the institution for each completed SAE report. This fee covers the cost of gathering all SAE information. This is an hourly fee and the amount invoices will be based on the time spent to complete the SAE report.
The sponsor pays a close-out fee upon completion of all study-related procedures, including resolution of all queries and notification of study closure from the IRB.
The sponsor pays an archiving fee upon study completion. This fee covers the cost of archiving and storing study documents per the contract terms. Additional fees may be applied if documents must be retrieved from storage at the sponsor’s request.
The sponsor pays a fee for room use for each visit that will occur within the UofL Clinical Trials Unit. This fee is incorporated into the per-visit payment. The hourly CTU room fee has been calculated based on clinic staff, rent and supply costs.
The sponsor pays a drug storage and accountability fee when study drug is stored and dispensed from the UofL Clinical Trials Unit. This fee covers the costs of drug storage, accountability and inventory keeping, dispensation per protocol, and destruction of study drug.
Email CTU for more information.