A CDA, also known as Non-Disclosure Agreement, is an agreement between the University and an outside entity (company or person) to facilitate discussions of confidential information. For companies, sharing information about their proprietary drugs, protocol, and other research and business developments can lead to research opportunities and relationships with University personnel; however, the company would not want such confidential information revealed to their competitors.
If you have a CDA that is not for clinical research or not otherwise associated with an existing sponsored project, please contact Technology Venture Commercialization (TVC).
What we Need to Review a Clinical Research CDA
If you have a CDA that needs to be reviewed, please send the following items to a Staff Specialist:
- An editable version of the CDA or let us know if you would like us to request an editable version from the sponsoring agency
- Contact information for the PI and department
- Contact information for the sponsor
Upon receipt of a Document Summary Sheet (DSS), we will assist with drafting, review, negotiation and execution. Even though an agreement may be entered into in relation to an individual area (e.g. PI, college, institute), it is ultimately a University agreement and should only be signed by a University authorized official. Once we have this material, OSP will review and respond to the sponsor within 5 business days.
The Importance of Clinical Research CDA Review
For the University, maintaining confidentiality can preserve the University's rights while ensuring compliance with all applicable laws and University policies. OSP has been charged with reviewing, approving, and executing all CDA's for clinical research at the University. The University's confidential obligations should always be subject to other legal and practical considerations. Some of the issues OSP can assist you with include:
- The University's duty to disclose records in compliance with GRAMA (open records law), and whether any third parties will need access to information (e.g., other vendors [system integration], consultants or subcontractors, etc.)
- The types of information that need to be exchanged to facilitate the business discussion or services and determining whether the definition of "confidential information" accurately reflects that understanding
- How "confidential" information will be identified
- How long information needs to be protected
- Whether or not to return or destroy confidential information once the relationship ends and whether to retain copies for archival/audit purposes