Confidential Disclosure or Non-Disclosure Agreements

The Confidential Disclosure Agreement (CDA) or Non-Disclosure Agreement (NDA) are basically the same. They denote an agreement between two or more parties to protect the exchange of confidential information

Defining CDAs and NDAs

A CDA or NDA assures the parties will protect any shared confidential information against unauthorized use or disclosure. A CDA or NDA is generally limited to a specific period of time.

In the case of industry sponsored clinical studies, the sponsor frequently will require a signed CDA or NDA  before disclosing its confidential information (e.g., the study protocol, study feasibility questionnaire or investigator brochures) to an investigator or institution. Often an investigator uses a disclosure and the shared information to evaluate whether he or she is interested, has the right patient population and any other requirements for participation in the study.

On this page:

Who can sign a CDA?

UB has a list of authorized signatories who are indemnified from liability by the Research Foundation.  Please do not sign the CDA yourself, as investigators are not an authorized signatory.

Why do we need a CDA or NDA?

We use a CDA or NDA to protect confidential information. In the case of an industry sponsored clinical study, a CDA or NDA obligates the investigator, as well as any university staff sharing the information, to keepit confidential for a set period of time and to use the information only in determining an interest in participating in the study.    

If a researcher submits a proposal to an industry partner requesting support (funding, drugs or other material), for an investigator initiated study, he or she typically puts a CDA or NDA in place prior to submitting the proposal. This protects the investigator’s ideas as well as the study design. In this case, the investigator may need to initiate the CDA or NDA, using the standard UB request form, available online.

Who do we work with to complete a CDA?

For industry sponsored clinical studies, generally the CDA is initiated by the sponsor. If you receive such a document, it should be uploaded to Click under the 'Agreements" tab.'  Once this is complete, the CDA will be assigned to a Clinical Contracts Administrator, Elizabeth Parsons or Conor Flynn, for review.  They can answer any questions you may have about a CDA or NDA.            

If you have questions about CDAs for other types of studies, please refer to the Confidential Disclosure Agreement Request form.

How do we complete a CDA?

For industry sponsored clinical studies, the contract administrator will review a CDA within one week and send it back to the sponsor or the clinical research organization working on behalf of the sponsor.  CDAs are required to be submitted into Click under the 'Agreements' tab.  Negotiation can take some time, but CDAs can usually be turned around quickly if everyone is able to start discussions related to the study.