Also known as an IP Management Agreement, an Inter-Institutional Agreement (IIA) is a legal contract to provide for joint management of jointly owned intellectual property. IIAs delineate which party will take the lead on patenting and commercializing the resultant intellectual property as well as how the legal expenses and license revenue will be shared among the institutions that assert the ownership rights to the joint invention(s).
A Data Use Agreement (DUA) refers to a legal contract concerning the transfer of human subject data which includes PHI (typically but not exclusively in the form of a Limited Data Set). It is required to obtain satisfactory assurances that the recipient of the Limited Data Set will use or disclose the PHI in the data set only for specified purposes. DUAs are subject to HIPAA regulations and usually require IRB approval.
A Data Transfer Agreement (DTA) is a legal contract governing the transfer of non-human subject data or completely de-identified human subject data. It sets out the related protections, rights, and obligations of both parties and delineates the specific purpose(s) for which the data may be used.
A Collaborative Research Agreement (CRA) is a legal contract between Mount Sinai and one or more organizations, where the parties agree to contribute resources, such as materials, equipment, or specialized expertise, and work together collaboratively to find an answer to a particular research inquiry. A CRA describes the actions that each organization has agreed to undertake, and defines the obligations each party has to the other(s) participating in the collaborative research effort. CRAs are typically unfunded.
An agreement governing negotiating an agreement with a third party who is not the Sponsor, i.e. CRO whereby the CRO is executing the agreement on behalf of the Sponsor.
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.