Confidentiality Disclosure Agreement In Clinical Research

In the case of an industry-sponsored clinical trial, a CDA or NDA requires the controlling physician and any university staff member who shares the information to keep it confidential for a specified period of time and to use it only to determine the value of participating in the study. A Confidential Disclosure Agreement (CDA) is a legal contract that obliges the parties to the execution of the agreement not to disclose proprietary information covered by the CDA. A CDA describes the extent of confidential information that the parties wish to share for specific purposes. A CDA is also called a confidentiality agreement (NDA), confidentiality agreement or confidentiality agreement. Once SP receives a fully executed CDA, the agreement is processed and a copy is sent to the PI for its files. Once a sponsor or contract research organization (CRO) has identified the UCI as a potential site for a clinical trial, a CDA can be sent to PI. In order to protect the university and pi, all incoming CDAs requiring an academic signature must be controlled, negotiated and executed by Sponsored Projects (SP). Jefferson employees cannot execute a CDA in Jefferson`s name. Jefferson CDAs` authorized signatories are the Vice President, Innovation Management (excluding clinical trial-related CDAs) and the Director of the ORA (only for clinical trial-related agreements). A CDA is set up before establishing an industrial or external academic contact for the disclosure or obtaining of confidential information.

If a company, academic institution, or person outside of Jefferson approaches Jefferson personnel to disclose or obtain confidential information, such Jefferson employees must contact the innovation team to set up a CDA before taking any action. If the confidential information is related to clinical trials, please contact our Office of Research Administration (ORA). . . .