The Financial Administration of Clinical Trials Services (FACTS) office at the Icahn School of Medicine at Mount Sinai (ISMMS) is the center for coordinating the financial aspect of your clinical trials.
A Clinical Trial is defined by the FACTS Office as a research study where the objective is either:
- Testing of drugs, devices, diagnostics, treatments, interventions or preventive measure including testing for an unapproved indication or Data collection to increase knowledge that would lead to enhanced safety and efficacy of a drug or device.
- The study must involve contact with humans, inclusive of medical record reviews.
- The source of funding or support must be a for-profit entity.
FACTS offers a range of services that assist investigators and research personnel with the pre-award submission process and the post-award management of industry-funded clinical trials. These services include:
- Negotiating and executing the following types of agreements. See definitions.
Clinical Trial Agreements
Confidential Disclosure Agreements
Confidential Disclosure Agreements
Site Agreement/Sub-Award Agreement
Research Service Agreement
- Helping with budget development and negotiation
- Assisting with Medicare coverage analysis (MCA)
- Preparing subagreements for multicenter clinical trials
- Submitting CMS letters for device trials
- Monitoring clinical trial fund accounts
- Approving financial transactions, including fund closeouts
- Assuring payment for registry studies represents fair market value
- Ensuring consistency of all clinical trials documents
- Negotiate Master Clinical Trial Agreements. See List of Current Master CTAs
All requests for review of a CDA or CTA must be done via the Meditract Contract Life Cycle Management system. Meditract enables you to know where your contract is located in the negotiation process at any time. This will facilitate quicker turnaround time in negotiation and assist the FACTS team with Metrics along with full transparency of the contract process flow. View CDA Process Flow and view Clinical Trial Agreements Process Flow.
How to submit contracts for negotiation through Meditract:
Meditract (contact the FACTS office for login information)
Initiating a Contract in Meditract
Below is the budget development for an industry-sponsored clinical trial study.
- The sponsor of the clinical trial will send a protocol and budget overview/template for the trial.
- After reviewing the protocol and events schedule, modify the budget to reflect all ISMMS costs in order to conduct the trial.
- Determine if the labs and testing procedures will be done in-house or at the sponsor’s site.
- Determine if there will be professional charges required for the technical tests performed.
- Edit the sponsor’s budget to reflect all costs of the trial (please use template Industry Sponsored Budget Worksheet to create budget).
- Determine which services are standard of care versus clinical research.
- You may not bill insurance for a drug, test, device, or service paid for by the sponsor.
- A study start-up fee must be included in order to cover the following costs: protocol review, staff training, budget preparation, regulatory documents, and administrative fees.
- One-time costs that must be included in the budget, if applicable: IRB fees, IRB continuing review fees, IRB amendment fees, investigational drug set-up fees, MCA preparation fee, archive fees, and advertising costs.
- The Clinical Trial indirect cost rate of 35 percent is an additional charge that must be applied above to the total direct clinical costs. Only IRB fees are exempt. Indirect costs help to cover a small part of the infrastructure costs at ISMMS.
- Determine time and effort of staff on study.
- For multi-year clinical trials, consider adding an inflation rate of 10 percent to the per-completed-subject cost.
- Holdback on trial should not exceed 20 percent.
- For assistance with budget negotiations and obtaining research fees, contact the FACTS office.
Medicare Coverage Analysis
A Medicare Coverage Analysis (MCA) is a document that determines the appropriate payor (i.e. sponsors, Medicare, or third-party) for each item and service required by a clinical research trial.
An MCA is required for all clinical trials in which tests, procedures, and interventions associated with a clinical trial are invoiced to third-party payors, and when research procedures are paid for by sponsors.
Since an MCA reduces the risk for submitting false claims by identifying which services are paid for by sponsors and which services are for research purposes only, it is the basis of research billing compliance. An MCA also assists in budget negotiation with sponsors.
An MCA is tracked by the FACTS office and prepared by the Biomedical Research Alliance of New York. The preparer consults with the Principal Investigator (PI) while preparing the MCA so that the PI’s expertise and insights are reflected in the final documents. The final MCA needs to be signed by the PI, and the billing grid needs to be used by the research coordinators and billers to ensure that all bills reflect the correct payor.
Any PI that has a project that requires an MCA must complete the Clinical Research Billing Rules for Investigators training.
Biomedical Research Alliance of New York (BRANY)
The Biomedical Research Alliance of New York (BRANY) is an alliance of academic medical centers designed to conduct high-quality trials for the pharmaceutical and biotechnology industries in the most efficient and cost-effective manner. This research consortium is owned by several New York metropolitan area institutions, including the Icahn School of Medicine, and serves as an outsourcing agent for ISMMS.
BRANY offers a variety of services, such as contracting and budgeting negotiation for multisite studies, monitoring investigator-initiated studies, preparing all MCA documents, and working with Principal Investigators to finalize all MCAs. If you would like to use BRANY services, please contact the FACTS office for more details and for fee schedules.
Financial Close Out of Industry-Sponsored Projects
Below are the steps for allocating the research funds at the end of a clinical trial.
If the remaining balance in the fund account is $2,500 or less:
The PI and the department administrator shall submit a memo certifying that the project has been completed and all obligations to the sponsor have been met with a request that the remaining balance be transferred to the departmental account. View a sample close out letter
If the remaining balance is greater than $2,500:
A letter from the sponsor is required stating that all obligations have been met and no money is due back to them. If a letter from the sponsor cannot be obtained, please fill out the closeout letter template and have it signed by the chairperson of the department.
Overhead will be charged on the remaining balance before the net unexpended balance is transferred to the department account.
If the account balance is negative, the department has to provide a funding source to cover the deficit so the account can be closed.