Yale Data Use Agreement

No. Please note that Yale`s guidelines do not authorize the purchase of investigational drugs, including FDA-approved products used in an IDE study for an indication for which the device has not been officially approved. Products must be provided free of charge by the sponsor or be fully refundable under the study participant`s insurance, under the CTA`s terms, to ensure the sponsor`s liability for all uncovered costs. Any exceptions to this rule must be handled through your GCA Contract Manager using a dedicated wavier that can be used in exceptional cases. Under no circumstances should the study sponsor work independently with YNHH to negotiate separate agreements for the test equipment. A Data Use Agreement (DUA) is an agreement required under the confidentiality rule and must be entered into before a limited record (defined below) is used or disclosed to an external institution or party. A limited record is always protected by Health Information (PHI), and for this reason, covered companies like Stanford must enter into a data use agreement with each recipient of a limited Stanford record. require recipients to ensure that all agents (including subcontractors) to whom they disclose information agree to the same restrictions set out in the Agreement; and yes, you will need both a Data Use Agreement (DUA) and a Business Partnership Agreement (BAA) because the relevant entity (covered entity affiliated with Stanford University) provides the recipient with PSRs, which may contain direct or indirect identifiers. For this reason, a BAA may be required before we transmit the direct identifiers to the recipient outside of Stanford. All incoming ATMs for Yale researchers to obtain documents from academic, government, nonprofit, and for-profit corporations, and outgoing MTAs to share Yale materials with academic, governmental, and nonprofit institutions, are reviewed, negotiated, and signed by the OSP MTA team. Outgoing MTAs to provide Yale materials to commercial and for-profit institutions are negotiated by the Office of Cooperative Research (OCR). Enquiries should be directed to ocr@yale.edu.

prohibit the recipient from further using or disclosing the information, except to the extent permitted by the Agreement or otherwise permitted by law; determine the permitted uses and disclosures of the limited data set; Compensation is a contractual agreement to compensate someone for certain losses. Compensation is provided in contracts for sponsored research, clinical trials, material transfer agreements, and intellectual property licenses. In general, a sponsor must agree to defend and indemnify Yale from and liable for any claim or liability arising out of the research, except those arising out of gross negligence or wilful misconduct on the part of the university. If Stanford is the provider of a limited dataset, Stanford requires a DUA to be signed to ensure that the appropriate provisions to protect the limited dataset are in place. Here are the contacts for different types of research: A covered entity (like Stanford) can use a member of its own staff to create the “limited dataset.” On the other hand, the recipient can also create the “limited registration” as long as the person or entity acts as a business partner of the covered company. The following page provides useful information about the people who internally manage various types of DUAs and other agreements at Stanford: ico.sites.stanford.edu/who-will-handle-my-agreement Require the recipient to take appropriate safeguards to prevent unauthorized use or disclosure not provided for in the agreement; This means that all of the following direct identifiers relating to the person or their relatives, employers, or household members must be removed in order for a record to be considered a limited record: If a Stanford researcher is the recipient of a limited dataset from a source other than Stanford, the Stanford researcher may be asked to sign the other party`s DUA….

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