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
Also referred to as a non-disclosure agreement (CDA or NDA), is an agreement governing the exchange of confidential information. It is designed to protect the confidential information that may be released between a for-profit entity and the faculty and staff of the Icahn School of Medicine (ISMMS) so that they may determine whether or not to enter into a subsequent agreement for a clinical trial.
Research consortium owned by several New York metropolitan area institutions, including the Icahn School of Medicine.
BRANY offers a variety of services, including:
An industry funded agreement by entities with an economic interest in the sale of a product where the study looks at the use and or outcomes of use of their product subsequent to selling to MSH at the full commercial price.
An agreement governing the conduct of a study based upon a protocol authored by an ISMMS Investigator/Sponsor Investigator. A for profit entity provides funding and/or drug or device.
A letter issued by a for-profit entity which promises by written confirmation to act as a 3rd-party on behalf of the first party in a transaction or contract. This 3rd-party covers loss or damage to the 2nd-party in the agreement caused by the first party.
Applications that compete with other applications for funding. These include New, Competitive Renewal, Re-submission, and New Supplement Applications.