The OCT is available to assist PIs and their research teams with
budget development as well as negotiations with sponsors/CROs. Should
the PI/research team choose to negotiate their own budgets with the
sponsor, the following expense items are to be included:
- Costs for tests and procedures
- IRB processing fees
- Institutional Overhead of 35%
Other Montefiore-Einstein fees are applicable in building the budget.
OCT personnel will help you identify the proper charge for each of
these fees which include but are not limited to:
- CRC fees
- OCT fees
- Pharmacy fees
- Study site activation charges as needed
All human subject research is reviewed by the Compliance department
to determine if Medicare Coverage Analysis is required. To make this
determination the OCT needs:
- The study protocol
- Institutional Review Board application
- Study Award information
- Final Budget
After the Office of Compliance has reviewed the relevant materials, a
draft-billing plan will be provided to the PI for review and approval.
This plan will be crafted with the Compliance department.
Contact: Joann Oscar
Title: Sr.Compliance Analyst/ Research Billing Comp Officer
Phone #: 718.920.8986
If a research project does not require a billing plan, an email
notice will be sent to the PI, IRB, and all impacted affiliates
indicating that no billing plan is required.
Medicare Coverage Analysis
The Compliance department is responsible for creating a Medicare
Coverage Analysis for any procedure within a clinical trial that will be
billed to the patient’s insurance carrier. The purpose of this
analysis is to show that third party payers will cover the
tests/procedures. This is an internal document and is used for auditing
purposes. OCT personnel will assist the PI in obtaining this billing
How do I do a budget if the sponsor has not provided one?
Answer: The OCT Manager assigned to your project will assist you with the creation of a budget.
What format should I use?
Answer: The Office of Clinical Trials has a budget template for your use.
What are direct costs?
Answer: Direct costs are charges for services, time and effort required
to perform the work stipulated within a contract and identified with a
specific project or program.
What are indirect costs?
Answer: Indirect costs are applied to procedures, tests and work that require time and effort on the part of the research team.
What is our level of institutional overhead expected from sponsors?
Answer: The institutional overhead for all industry supported clinical trials is generally 35%.
Once I have developed the budget, what is my next step?
Answer: When you have developed a budget; send it to the OCT for a final
review for any institutional charges that need to be included or any
changes that might be required.
Should I also develop payment terms?
Answer: Payment terms are negotiated by OCT.