Confidential Disclosure Agreement (CDA)
What is a Confidential Disclosure Agreement (CDA):
A Confidential Disclosure Agreement (“CDA”), sometimes called a “Confidentiality Agreement” or “Non-Disclosure Agreement,” is a legal document which ensures the confidentiality or “secrecy” of information that one party discloses to another party. A signed CDA may be required before an industry sponsor agrees to disclose its proprietary information (e.g., the study protocol) to an investigator. The Office of Clinical Trials (OCT) is responsible for reviewing CDAs related to the evaluation of industry-supported clinical research studies conducted at the Medical Center.
Who are the Parties to a CDA:
The Medical Center prefers that CDAs be entered into directly between a sponsor and the individual faculty member evaluating the clinical research study. In such cases, the parties to the CDA will be the sponsor and the faculty member. However, some companies require that an institution sign the CDA. In those instances, the parties to the CDA will be the sponsor and the institution, namely “New York University School of Medicine, an administrative unit of New York University.”
For cases where the faculty member wishes to sign a CDA (i.e. CDAs between the sponsor and individual PI only) see the CDA checklist and FAQ section below.
Terms of the CDA:
The terms and conditions of a CDA are negotiated in accordance with NYUSoM policy. OCT staff will negotiate with the Sponsor until the agreement is acceptable to both parties. OCT review of the CDA is important since the terms negotiated in this agreement will may be incorporated into the provisions for the study specific Clinical Trial Agreement.
The time for review of CDAs is generally not as lengthy as that of CTAs. OCT attempts to review initial drafts of CDAs within one to two days after receiving the CDA. On average, the process of review, negotiation and execution of a CDA takes between 10-15 business days.