Confidential Disclosure Agreement (CDA)

What is a Confidential Disclosure Agreement (CDA):

A CDA is a legal document which ensures confidentiality of proprietary information that a sponsor gives to the investigator. A signed, study specific CDA may be required before a sponsor will provide its proprietary information, such as the study protocol, to an investigator.

NEW: Video - OCT Director Jean Gatewood discusses changes related to CDAs and other information.

Who are the Parties to a CDA:

The School of Medicine prefers CDAs to be made between a sponsor and the individual faculty member (Principal Investigator).  However, some companies require that the Institution also sign the CDA, in which case the Office of Clinical Trials will sign on behalf of the School of Medicine.

Please note: Even if only the Principal Investigator signs the CDA, the OCT must review and negotiate the CDA beforehand to ensure that the terms are acceptable according to the School of Medicine’s policies.

Terms of the CDA:

The terms and conditions of a CDA are negotiated in accordance with School of Medicine 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.

Review Timeframe:

The time for review of CDAs is generally not as lengthy as that of CTAs.  The 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.