The Office of
1109-A Bioinformatics Bldg.
130 Mason Farm Rd.
CB 1651
Chapel Hill, NC 27599-1651
919-843-2698 ph
919-843-2399 fax
A successful clinical trial will include a budget that adequately meets the financial needs of conducting a trial. Since costs vary across the nation for supplies and services, budgets are almost always negotiable.
Sponsors usually use 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 your responsibility to ensure that the amount agreed upon will adequately cover all costs associated with conducting a clinical trial.
If you would like, you may fax, email or send a hard copy of your proposed budget along with a copy of the protocol to OCT for review. A clinical trials project manager will evaluate your budget and provide advice and recommendations to ensure that the budget meets your needs.
According to the University policy, studies meeting the definition of a clinical trial are subject to the standard University Facilities & Administrative (F&A) cost rate. For fiscal year 2003, this rate is 26%. For more information, see the F&A Rate Reduction Request forms.
Effective July 1, 2003, the rates applied to industry funded clinical trials will be:
Please note that retrospective research, data registries, etc. do not meet the clinical trial definition and therefore are not eligible for the clinical trial rate. More information about these types of studies.
Typically, F&A costs are not waived for industry sponsors. To do so would force the university to subsidize the performance of sponsored research with university dollars for a for-profit corporation. See the university policy on F&A costs. Requests for reduction or waiver of F&A costs must be sent to the Associate Vice Chancellor for Research. View a list of all documents related to F&A.
Please ensure that all fees (except the IRB fee) include F&A costs. This includes GCRC fees and all invoiced costs such as MRI's, EKG's, advertising, etc. For example, the sponsor will reimburse the P.I. $1,000 for an MRI required by the protocol. Divide the total amount by 1.26 (or 1.264 after 7/1/2003) to determine the amount you will have available to pay the fee after F & A cost rate is applied.
It is the policy of the University to charge a sponsor $2,000 for every trial that is reviewed by the IRB. This is a one-time fee that covers the initial application, amendments, renewals, SAE reporting, etc. The IRB fee is not subject to F&A costs. The OCT will send an invoice for the IRB fee to the sponsor with the CTA. It is strongly preferred that the IRB fee be written into the CTA and is not dependent on a payment schedule (see below). It is due upon invoice. Please ensure that the sponsor is aware of this fee and that it is written into the budget.
When evaluating your budget, please rememeber that all investigational drugs must be stored and dispensed from the Investigational Drug Services pharmacy. Fees vary depending upon the type of trial you are conducting. It is expected that the pharmacy fees will be included in your budget. The pharmacy fee is exempt from F&A. Please be sure you understand the fee structure especially when you are negotiating this part of the budget.
Please click here to obtain more information on IDS.
Trials require expenditures that aren't always obvious. Include:
Carefully examine the budget for the time requirements. Most protocols include a "schedule of events" which breaks down all study tasks required by the protocol.
All trials require a significant amount of time before enrollment actually begins. Consider time spent doing the following:
Translate the activity into a measure of time. For example, the schedule of events may list that vital signs are to be taken at each visit. How long does it take to complete a set of vital signs? Also, keep in mind the time required to draw blood. How long does a difficult blood draw take? How long will it take you to process and package the specimen? If you have to make telephone calls, estimate the time required. Consider worst-case situations. Also consider the time spent doing the following:
The trial will require time outside of the protocol. Calculate the time you will spend actually running the trial. Include:
98 account numbers are needed to bill hospital procedures and other services associated with clinical trials. This avoids patient billing for tests required by the protocol.
If the protocol requires ECG's, the use of the hospital lab for tests, the use of the GCRC or other hospital services, you will need to apply for a 98 account. For more information, you may contact either Amelia Rountree at 966-7603 or the Office of Clinical Trials at 843-2698.
If the protocol requires the use of radiology, you may contact Debbie Wolfe at 966-6644 or by email: dwolfe@unch.unc.edu
It is always helpful to send them the table or schedule of events so that they are aware of the tests the protocol requires. If you need a quote on the full price of the tests, please indicate this in your request.
Once the account has been billed, an invoice will be sent to the investigator for payment. The department administrator will pay this bill with the funds received from the sponsor for the trial. Each trial should have its own 98 account number. Balances are the responsibility of the investigator. Make sure to review each bill carefully in order to ensure that the account was billed appropriately. If you find errors, please contact Amelia Rountree at 966-7603 for resolution.
Sponsors will usually specify certain milestones that must be achieved before payment is made. Pay close attention to the timing and requirements of the milestones. Payment schedules may be appended to the contract as a table or may be written as a paragraph within the contract. Please see below for an example of a common payment schedule for a trial with 10 patients at $2500/subject.
| PAYMENT | MILESTONE | AMOUNT |
|---|---|---|
| 1 | Initial Payment upon drug shipment | $2500 |
| 2 | After 3 subjects completed | $7500 |
| 3 | After 2 subjects completed | $5000 |
| 4 | After 2 subjects completed | $5000 |
| 5 | Final payment after all Case Report Forms are completed, queries are resolved and close out visit is complete | $5000 |
A preferred payment schedule would be:
| PAYMENT | MILESTONE | AMOUNT |
|---|---|---|
| 1 | Initial Payment + IRB fee upon contract execution | $6500 |
| 2 | After 3 subjects randomized | $7500 |
| 3 | After 2 subjects completed | $5000 |
| 4 | After 2 subjects completed | $5000 |
| 5 | Final payment after all Case Report Forms are completed, queries are resolved and close-out visit is complete | $2500 |
Occasionally, initial payment will not be sent until a subject is randomized. This situation is not acceptable. If a subject is never randomized, no payment will be received and you have incurred costs that will not be reimbursed. Instead, ask for a reasonable initial payment that will cover your startup costs. This amount should be adequate to cover all costs incurred with initiating a trial including the IRB fee in the event that the trial never begins.
Look at your milestone payment. Will you be paid on completion of Case Report Forms? That may mean waiting until the monitor has reviewed the CRF's and sent them into data management. Will you paid on completion of a subject's participation in the trial? This may delay payments. An ideal schedule will reimburse after a reasonable amount of subjects have randomized or after a certain number of visits are completed so that your study account does not run in a deficit.
Sponsors may also choose to hold back a significant portion of payment until all study activities are complete. Ensure that this is not an excessive amount. 10% of the total budget would be ideal. Final payment may or may not depend upon waiting until ALL sites are closed or until the database has been closed. Pay close attention to this because it can mean that final payments may be delayed for an unreasonable amount of time.
An ideal payment schedule would include the following:
Not every subject enrolled in a trial will complete the trial. Ensure that the budget and payment schedule provide for these circumstances adequately.
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