Sample Generic Confidential Disclosure Agreement - Free Download
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Sample Generic Confidential Disclosure Agreement
Sample Generic Confidential Disclosure Agreement
Confidential Disclosure Agreement (“CDA”) FAQs
1. 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.
2. 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.
3. What are my obligations under a CDA
While most CDAs contain similar obligations, there may be additional obligations or somewhat different
obligations under your specific CDA than the obligations noted below. You are responsible for reviewing
and complying with the terms and conditions set forth in your specific CDA, whether you sign it or the
Medical Center enters into it on your behalf.
Under virtually any CDA, you are responsible for maintaining the confidentiality of the information
which is defined as confidential under the CDA, for not disclosing such information except as permitted
under the CDA, and for not using such information except for the evaluation of the proposed clinical trial.
As part of this obligation, you should take care to treat the information like your own confidential
information or even your patients’ private information. You should tell anyone at the Medical Center
with whom you share the confidential information provided to you of the confidential nature of the
information and your obligations under the CDA. You should refrain from co-mingling the confidential
information with other information. You should return or destroy the information if required by the
disclosing party and keep one copy for your records if permitted by the CDA. If the evaluation results in
your and the Medical Center’s agreement to perform the clinical trial, you should review and follow any
confidentiality obligations outlined in the resulting clinical trial agreement.
4. I have been presented with a CDA with the sponsor and NYU School of Medicine as the parties.
I need to have this CDA signed ASAP. What should I do
DON’T SIGN THIS DOCUMENT. You are not authorized to sign CDAs for the institution. Only
delegated signatories in the OCT are authorized to sign CDAs with industry sponsors related to clinical
research studies.
Instead, email the CDA to the OCT Contracts Manager (Susan.Shin.Andersen@nyumc.org) or the
Clinical Research Management Coordinator (“CRMC”) for your department. The OCT will help you
obtain a Study Number (“S #”) for the CDA and then will negotiate the CDA terms with the sponsor. The
OCT makes every effort to review initial drafts of CDAs within one to two business days after receiving
the CDA. On average, the process of review, negotiation and execution of a CDA takes between 10 to 15
business days.
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