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
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.