Data Use Agreement Yale
Require the recipient to adopt appropriate security measures to prevent unauthorized use or disclosure that is not included in the agreement; Compensation is a contractual agreement for the reimbursement of certain losses. Compensation is the result of sponsored research contracts, clinical trials, equipment transfer contracts and intellectual property licensing. As a general rule, a sponsor should agree to defend Yale and compensate for claims or undertakings arising from the research, with the exception of those resulting from gross negligence or wilful misconduct by the university. A Data Use Agreement (AEA) is an agreement that is required and must be entered into in accordance with the data protection rule before a limited data set (defined below) is used or disclosed to an external institution or an external party. A limited set of data remains health information (PHI) and that`s why covered companies, such as Stanford, must enter into a data usage agreement with each recipient of a limited set of Stanford data. Outgoing MTAs, which supply Yale materials to commercial and for-profit institutions, are negotiated by the Office of Cooperative Research (OCR). Please contact OCR@yale.edu or call the OCR at 203-436-8096 (Central Campus) or 203-785-6209 (School of Medicine). See: ocr.yale.edu. An AED must be completed before a limited data set is used or disclosed to an external institution or an external party. No no. Please note that Yale guidelines do not permit the purchase of test devices, including FDA-certified devices used in an IDE study for an indication for which the device has not been officially approved. The devices must be provided free of charge by the sponsor or fully reimbursed as part of the insurance of the university subject, according to the conditions of the CTA, in order to guarantee the responsibility of the sponsor for all costs not covered. Exceptions must be managed through your GCA Contract Manager using a special wavier that can be used in exceptional cases.
Under no circumstances should the sponsor of the study ever cooperate independently with YNHH to negotiate separate agreements for test devices. In addition, covered companies such as Stanford must take all reasonable steps to remedy a beneficiary`s violation of the AEA. For example, if Stanford learns that the data it has provided to a recipient is being used in a way that is not authorized by the AEC, Stanford should work with the recipient to resolve this issue. If these efforts were not successful, Stanford would be required to terminate any further disclosure of PHI to the recipient, in accordance with the AEA, and to notify the Federal Office of Health and Human Services for Civil Rights.