Clinical studies are usually funded on a per-patient basis with provisions for pro-rated payment for patients who do not complete the study. All costs necessary to conduct the study, including salaries, procedures, services, supplies and indirect costs, should be considered when determining the fixed per-patient amount.
Sponsors usually apply one of two options when presenting a budget. They may offer a certain amount per patient and ask that you work within that amount or they may ask you to formulate a budget for them. Regardless, it is the principal investigator’s responsibility to ensure that the amount agreed upon will adequately cover all costs associated with conducting the study.
If you have questions about how to correctly price or budget a clinical trial, contact the Research Administration and Compliance Office.
The budget period for a clinical trial will equal the trial’s contractual date or the IRB end date whichever occurs first. Upon IRB renewal and notice to DSP’s Award Administration at email@example.com, your project end date will be adjusted accordingly in the accounting system.
The established Indirect costs (IDC) rate for non-federal clinical trials at the University of Florida is 28% of total direct costs (TDC). When budgeting, add 28% of the direct costs to your total. Example: $1,000 of direct x 1.28% = $1,280 total cost.
UF’s IDC rate for clinical trial is 28% of total direct costs. When payment is received, 21.875% of total cash received is assessed for indirect costs while the remaining direct component is released into the 214 project for spending.
For example, if a $15,000 payment is received from a clinical trial sponsor; then the payment will be split into directs and indirects as follows: $15,000 payment x 21.875% = $3,281.25 for indirects, leaving $11,718.75 for the direct costs.
All investigators are required to use WIRB (IRB-04) for industry sponsored Clinical Trials, unless an exemption is granted by the College of Medicine’s Dean’s Office. The WIRB fees may be charged directly to the industry sponsored CTA, or the sponsor may elect to pay WIRB directly. If the latter is the case, the WIRB invoice must be sent to the sponsor for payment.
All non-industry funded clinical trials are reviewed by the University’s appropriate IRB office which does not charge a direct fee for their service.