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 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

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 must be reviewed, negotiated and executed by the PI, University Official and the Company.

Negotiation CDA’s are usually straightforward and require little negotiation Point of contact: Roseann Talarico – Most are negotiated within 5-10 business days Include the name, address, telephone number and the Sponsor/CRO /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