Frequently Asked Questions
How do I do a budget if the sponsor has not provided one?
Answer: The Research Management Coordinator (RMC) assigned to your project (determined by therapeutic area) will assist you with the creation of a budget, when requested. Before asking for assistance, a review of the visit schedule of your protocol is required to determine which procedures are considered 'research' and which are 'standard of care'. This may require a discussion with the Principal Investigator. When you know the answers for the billing information; contact the RMC. The collaborative process will begin here. The Office of Clinical Trials will provide the coordinator with a budget template to work with.
What format should I use?
Answer: The Office of Clinical Trials has budget templates for your use.A budget can be created via using excel, the protocol (schedule of events and sections of the protocol), ICF, Lab manual, radiology manual etc. An itemized budget should outline the services billable to a 3rd party payor (SOC/CC) and/or to the sponsor. You should put in if the service would be billed to a 3rd party payor by indicating (SOC/CC) or if billed to a sponsor by indicating the negotiated rate.
A SAMPLE BUDGET FORMAT
| Visit 1 | Visit 2 | |
| EKG | $150.00 | $150.00 |
| CBC with diff. | SOC/CC | SOC/CC |
What is the institutional overhead?
Answer: The institutional overhead for all industry supported clinical trials is 30%.
What are Facilities & Administrative (Indirect) costs?
Answer: F&A, formerly known as Indirect costs, are applied to procedures, tests and work that require time and effort on the part of the research team. At NYU Medical Center the indirect cost rate is 30%. Examples of procedures that have F&A applied are: laboratory tests, radiology procedures, and coordinator time. F&A costs represent the expenses of doing business that are not readily identified with a particular grant, contract, project function or activity, but are necessary for the general operation of the organization and the conduct of activities it performs. In theory, costs like heat, light, accounting and personnel might be charged directly if little meters could record minutes in a cross-cutting manner. Practical difficulties preclude such an approach. Therefore, cost allocation plans or indirect cost rates are used to distribute those costs to benefiting revenue sources.
source: http://www.ed.gov/about/offices/list/ocfo/intro.html
Costs associated with the general operation of an institution and the conduct of its research activities. Allowable F&A costs include:
- Depreciation use allowance.
- Facilities operations and maintenance.
- General administration and expenses.
- Departmental administration.
- Sponsored project administration.
- Libraries.
What are direct costs?
Answer: Cost in a contract identified with a project or program. Allowable direct costs may include:
- Salaries and fringe benefits of principal investigators and supporting staff.
- Equipment and supplies.
- Travel expenses.
- Fees and supporting costs for consultant services.
- Contract services (also called sub-award).
- Costs for consortium participants.
- Inpatient and outpatient costs for human subjects.
- Alterations and renovations to facilities.
- Publications and other miscellaneous expenses.
Once I have negotiated the budget, what are my next steps?
Answer: When you have negotiated a budget; please send it to the OCT for a final review for any institutional charges that need to be included or any changes that might be requires. The budget should be sent directly to the RMC that is reviewing your trial.
Should I also negotiate payment terms?
Answer: Currently, the payment terms are negotiated by OCT. The OCT requires payments on a quarterly basis. The research team coordinator and/or Principal Investigator are welcomed to negotiate these terms. However, this information must be shared with the RMC working on the project so that the terms appear in the contract. Alternatively, the RMC can negotiate for you. If you have specific terms, please share them with the RMC.
