Confidential Disclosure Agreements (CDAs)

A confidential disclosure agreement (CDA), sometimes referred to as a confidentiality agreement or a non-disclosure agreement (NDA), is designed to protect the confidential information that may be released between an industry sponsor and Yale University faculty & staff so that they can determine whether or not to enter into a subsequent agreement for either a clinical trial (a CTA) or basic research (a sponsored research agreement or SRA). CDAs may be one-way or mutual and are generally requested by sponsors prior to disclosing a study protocol or other confidential information to Yale which the sponsor considers proprietary. Not all sponsors require a CDA prior to disclosure of confidential information.

The Yale University, Office of Sponsored Projects (OSP) negotiates and processes all CDAs pertaining to disclosures of confidential information for prospective clinical trials that involve Yale University faculty, staff, or resources. All such CDAs are between Yale University and the Sponsor or its designee (e.g., a clinical research organization or CRO).

OSP representatives are the only authorized signatories of such CDAs on behalf of Yale University (as outlined in the faculty handbook). Upon receipt of a CDA, please send the document, along with the contact information from the originating sponsor, to your OSP contract manager and your GCAT mailbox, so that it can be negotiated with terms consistent with Yale policies and procedures. Please be sure that no faculty or staff member signs a CDA unless specifically instructed to do so by an OSP representative.

CDAs must be project or study specific. One CDA cannot serve to cover a broad area of discussion or for multiple projects over a length of time. Each specific clinical must be clearly named or defined within each CDA to ensure that the description of confidential information is obvious and not ambiguous in the event of a dispute. Some sponsors mistakenly believe that if we have a Master CTA in place, a CDA is not needed. However, sponsor disclosure of confidential information prior to the execution of an trial specific-addedum or statement of work under a Master CTA (or a clinical trial agreement for that trial) will not be covered unless a trial-specific CDA is in place. A Master CTA does not cover disclosure prior to the Effective Date of the fully executed CTA.

Neither faculty nor staff can be listed as individual parties to a CDA, except in the case of a faculty or staff member serving as an independent consultant for the sponsor conducting work outside of Yale facilities and resources, in which case, Yale University is not a party, and those negotiations are not handled through OSP. Please note that CDAs generated directly between faculty members and a sponsor for independent consulting work cannot be used to cover disclosures pertaining to a subsequent CTA administered through Yale University.