An agreement governing the loan or lease of equipment to be used in conjunction with a specific Clinical Trial Agreement and at no cost to ISSMS. The agreement cannot be a prerequisite nor imply any future leasing or purchasing of the equipment between ISMMS and the company. Furthermore, loaned/leased products cannot be utilized simultaneously for clinical and research purposes.
An agreement used when a for-profit entity or clinical research organization (CRO) wants to assist the Investigator and his/her research team by providing startup funding while the clinical trial agreement is being negotiated.
An agreement governing responsibilities for the overall data management, monitoring, communication, and general oversight for a Multi-Center clinical trial. The agreement may be designated either by a for profit entity or by mutual agreement of the participating sites.
An agreement governing standard terms, pre-negotiated between parties that reduces the need to renegotiate common language and allows focus to be placed on specific individual study work orders, protocols, and budgets.
An agreement governing financial support from a for-profit entity/prime awardee or pass-through entity (i.e., ISMMS) for the performance of a substantive portion of the effort under the prime award. It does not include procurement of goods and services purchased under an award, as the providers of these goods and services have no programmatic responsibility.
An agreement governing an external site’s participation in an Investigator Initiated clinical trial as provided above.
An agreement governing the conduct of a study that is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes.
A Clinical Trial is defined by the FACTS Office as a research study where the objective is either the testing of drugs, devices, diagnostics, treatments, interventions or preventive measure. This includes 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.
A type of InfoEd submission in which Mount Sinai uses InfoEd internally at ISMMS only and not to submit an application to an extramural funding agency.
Other Term: non-S2S
A type of InfoEd submission in which Mount Sinai submits competitive NIH and other federal grants electronically to these agencies.
Other Term: S2S