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Confidential Disclosure Agreements (CDA)/ Non-Disclosure Agreements (NDA)

Confidential Disclosure Agreements (CDA)/ Non-Disclosure Agreements (NDA). Roseann Talarico Associate Director Office of Human Research. Two Types. One Way A company may want to send a protocol to the Principle Investigator (PI) so that he/she can decide whether to participate in the trial

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Confidential Disclosure Agreements (CDA)/ Non-Disclosure Agreements (NDA)

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  1. Confidential Disclosure Agreements (CDA)/Non-Disclosure Agreements (NDA) Roseann Talarico Associate Director Office of Human Research

  2. Two Types • One Way • A company may want to send a protocol to the Principle Investigator (PI) so that he/she can decide whether to participate in the trial • The protocol will have confidential information that the company needs to safeguard • The sponsor may wish to support a Principal Investigator by supporting travel to a conference which may have confidential information • Two Way (Mutual) or One Way Out • A Principal Investigator may want to request a sponsor to support their own research

  3. How does this work? • Principal Investigator contacts University administration looking for assistance • Sponsor contacts PI/Coordinator • Sponsor contacts University administration • In order to protect the University and the PI, all CDA’s require University signature • Each mustbe reviewed, negotiated and executed by the PI, University Official and the Company.

  4. Negotiation • CDA’s are usually straightforward and require little negotiation • Point of contact: Roseann Talarico – 3-4743 roseann.talarico@jefferson.edu • Most are negotiated within 5-10 business days • Include the name, address, telephone number and the Sponsor/CRO email/phone • If needed, include a note with any concerns about the CDA or what confidential information University may wish to protect • Once completed PI will receive executable copy – return to complete the execution process • Fully executed copy sent to PI for recordkeeping

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