Scientist working in a lab [View Image]
We can concurrently review your clinical trial agreement while your budget is being finalized.
We will need the following before we can execute a clinical trial agreement:
As you begin the process -
- Please be sure to familiarize yourself with the appropriate compliance notices pertaining to clinical trials/clinical research. For example, compliance notice 14-006.2, Industry-Sponsored and Investigator-Initiated Clinical Trial/Research Facilities and Administrative (F&A) Costs Rate, outlines the appropriate F&A (overhead) rate to be used for industry sponsored clinical trials/clinical research and investigator-initiated clinical trials/clinical research.
- Please note that the appropriate overhead rate to use for clinical trials/clinical research initiated or supported by a for-profit industry entity is 30% of the total direct costs.
- Review the definition of “Clinical Research” to ensure that your project qualifies for the 30% industry rate, or discuss your project with us first.
- Please upload the clinical trial agreement to RAMS-SPOT using the submit document for review feature and be sure to link the funding proposal.
- Provide us with the company’s contact information.
- Let us know if you would like help with the budget. See “Tips on preparing a clinical trial budget.”
VCU requires that investigators and key personnel complete the Collaborative IRB Training Initiative (CITI) Basic Course in either Biomedical or Social-Behavioral Research. If you have not yet done so, please click here for more information about the nature of the program and about registering to gain access.
Sample clinical trial worksheet
Please contact the Red Team to determine whether a confidential disclosure agreement needs to be put into place with the proposed funding entity.
We will need the following before we can execute an investigator initiated research agreement:
As you begin the process-
- Please note that the appropriate overhead rate to use for clinical trials/clinical research developed and initiated by VCU and supported by a for-profit industry entity is 30% of the total direct costs. You may also use the 30% total direct cost overhead rate for investigator-initiated projects funded by non-profit entities which are considered to be clinical research. If your industry project is not clinical research, you will be expected to use the appropriate rate based on VCU’s negotiated rate agreement with DHHS. Investigator-initiated Clinical Trials: (1) meet the definition of clinical trial as defined by NIH and in Compliance Notice 14-003.2; (2) are funded by for-profit or non-profit sources (including VCU); and (3) designate our PI as the “Sponsor” (i.e., responsible for protocol development, regulatory compliance, and oversight of the performance of the trial).
- Provide us with a proposal for review prior to submission to the sponsor. Some sponsors may require that your proposal be submitted by the Division of Sponsored Programs. If not, you may submit the proposal to the sponsor after DSP review. Provide us with the sponsor’s contact information.
- Let us know if you would like help with the budget. If the study is a "clinical trial" or "clinical research", review “Tips on preparing a clinical trial budget.”
Hands of business lady working on laptop [View Image]Fixed and administrative (F&A) costs
The F&A rates for industry-funded research are the same as for federally-funded research (see the DHHS Rate Agreement for the different categories), with the exception of industry-funded clinical trials. If your study falls under the definition of clinical trial/clinical research. To qualify for the clinical trial F&A rate:
- the study must meet the clinical trial or clinical research definition
- the study must be fully supported by an industry sponsor and
- a contract meeting university requirements for industry-supported clinical trials/clinical research must be executed by Sponsored Programs with the sponsor.]
then the F&A rate is 30% of the total direct cost.
Be sure you have used the correct F&A rate in your budget before presenting the budget to the company. Having to go back to the company and explain why the budget needs to be increased will delay the execution of an agreement and may result in a complete loss of support from the company.
With rare exceptions, VCU will not reduce or waive F&A costs on industry-funded projects. One exception is the case where the funding entity has a published maximum F&A rate that applies to all submissions for support of external funding.
When considering a clinical trial budget, it is unwise to start with the budget presented by the trial sponsor and then back into a detailed budget. The creation of an appropriate “build up” budget for a clinical trial is the only way to know how much the study will cost you, and it is critical for subsequent fiscal management of the study. It is also the best approach to ensure that subsequent billing of the sponsor or third party payors does not violate anti-kickback or Medicare as Secondary Payor laws and regulations.
The following steps may be useful.
- Determine the full cost to perform the study.
- Read and dissect the clinical trial protocol to identify any cost- generating activities.
- Don't depend solely on the protocol's study flow chart; other costs will likely be found in the protocol, e.g., costs associated with shipping and handling of samples, record retention costs, telephone and fax costs.
- Some costs will not be found in the protocol, but nevertheless will be incurred, e.g., time/cost associated with CRF completion and adverse event reporting, inflation for long-term studies, copy costs for x-rays, costs of monitor visits, close-out costs, etc.
- Remember start-up costs, e.g., WIRB fee for initial review, Research Pharmacy setup fee, etc.
- Personnel costs can be estimated using either a percent effort method or activity-based method (time expended by each personnel member for each activity). b. Identify which procedures are standard of care and billable to third party payors, and which procedures are study specific and billable to the sponsor.
- Identify which procedures are standard of care and billable to third party payors, and which procedures are study specific and billable to the sponsor.
- For each procedure, ask if it is an actual procedure for which a charge will be generated, e.g., an ECG, or if it will be covered only by personnel time/effort, e.g., obtaining informed consent, measuring vital signs, getting a history, etc.
- Total the costs of only those procedures that are study specific and not billable to a third party payor.
- If in doubt as to whether or not a third payor will cover a given expense, request a written determination in advance.
- List all other fees, e.g., advertising and other recruitment costs, departmental/divisional administrative time/cost, F&A.
- Compare your trial cost estimate with the funding first offered by the trial sponsor.
- Negotiate with the sponsor to address shortfalls.
- Don't be afraid to negotiate the shortfalls. Sponsors rarely, if ever, start by offering their top study reimbursement amount.