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.
- 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
Along with overseeing industry clinical trials, the FACTS office is also the liaison with the federal and State government in assuring that the federal acquisition regulations (FAR-52.219) and state contract requirements are observed by preparing appropriate small business plans which set goals that are established in the contract. FACTS searches for small businesses in order to meet these goals. FACTS also reports on the actual expenses to the federal and state government.