Budgeting
The OCT is available to assist PI’s and research teams with budget development and negotiations with sponsors. The PI/research team may negotiate their own budgets directly with the sponsor which should include costs for tests/procedures, regulatory cost, IRB fees, institutional overhead (30%), etc. The OCT has the responsibility to review all budgets prior to the execution of the Clinical Trial Agreement for adequate reimbursement.
FACILITIES & ADMINISTRATIVE COSTS (aka 30% Institutional Overhead Rate): 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.
Payment Schedule:
- The budget should include IRB Fees (IRB FEES).
- For trials involving study drugs or vaccines, the budget should include Investigational Pharmacy & Vaccine Lab Fees. (INVESTIGATIONAL PHARMACY FEES)
- For trials involving non-conventional correlative items, procedures & services - those fees should be included.
- The budget normally contemplates payment on a per-subject basis. It is desirable that the per-subject payment be a set fee upon completion of Study procedures or a partial fee equal to costs expended for the Subjects unable to complete the Study.
- Ideally, an amount equal to one complete subject will be paid at start-up and will be non-refundable. This amount is a pre-payment for the completion of the first subject.
- Payments are made on a quarterly basis from trial start-date.
