A CDA is a contract governing the obligations of the parties who receive and/or disclose confidential information. For example, an industry sponsor may wish to disclose a study protocol to a PI for a feasibility review but the protocol may include confidential information that must be safeguarded. These agreements are sometimes referred to as, “Non-Disclosure Agreements” (NDA). The types of CDAs/NDAs are described below:
A Sponsor-initiated CDA is required prior to a sponsor releasing confidential information, such as a protocol, to a PI. The terms of the CDA govern the PI’s obligations of confidentiality with respect to the information disclosed. The CDA also protects UTHealth Houston when it is a party to the agreement. This would be considered a one-way CDA.
A Mutual Disclosure CDA is entered into when both industry sponsor or academic institution and UTHealth Houston exchange confidential information to determine a business or research relationship. For example, a PI may disclose a protocol he or she designed to an industry sponsor to see whether it will provide a drug or device for the study and the sponsor may share proprietary information about the drug or device. This would be considered a mutual CDA. Mutual CDAs are negotiated through the Office of Technology Management
An Investigator-initiated CDA is entered into when a PI discloses confidential information to industry or an academic institution but they are not disclosing any confidential information to UTHealth Houston. This would be considered a one-way CDA.
The pharma/device company will generally send a CDA/NDA to the PI or the department for signature. The PI/department will forward the CDA/NDA to SPA for the negotiation of the legal terms of the agreement.