Start-Up and Maintenance Fee Explanation

Administrative Start-up 

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, establishing the project in our e-Regulatory system, preparing and submitting regulatory documents and required documentation to the IRB, preparing the coverage analysis and budget, completing training for sponsor systems, and logistical set up for patient flow. This fee is due upon contract execution and receipt of invoice. 

IRB 

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 

Affiliate

If the study is conducted in locations outside UofL space, additional fees will be applicable. These include standard fees charged by the affiliated hospitals and clinics.

Administrative Annual

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 the preparation and submission of annual IRB renewals, maintaining the project in our e-Regulatory system, and required regular maintenance such as safety reports, site-required IRB submissions, CTMS maintenance, reporting for billing compliance, etc.

Amendment – Regulatory and or Financial

The sponsor pays the institution an amendment fee for each sponsor-required amendment either for the IRB submission or budget/contract. 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, or cost of reviewing and finalizing contract amendments.

Pre-Screening

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/clinic schedules for potential eligible subjects.

Training

The sponsor covers additional training costs for all personnel on the DOA or 1572 if training is required through a sponsor system after the start up period. This is an hourly fee and the amount invoiced will be based on the time spent to complete the training.

Sponsor/FDA Audit

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 days spent to complete the audit.

Local SAE Reporting

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 invoiced will be based on the time spent to complete the SAE report and any required follow up.

Administrative Close-Out

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.

Archiving

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.

CTU Outpatient Research Clinic Exam Room

The sponsor pays an hourly fee for room use for each visit that will occur within the UofL Clinical Trials Unit Outpatient Research Clinic.

Drug Storage and Accountability

The sponsor pays a drug or device storage and accountability fee when study drug or device is stored and dispensed from the UofL Clinical Trials Unit. This fee covers the costs of storage, accountability and inventory keeping, dispensation per protocol, and destruction or return of study drug or device.

Email CTU for more information.