The CDA must be reviewed and executed by the Office of Research Contracts (ORC). CDAs are executed by the University to cover all Duke personnel involved in the research project. However, certain CDAs require the PI’s signature as ‘Read and Acknowledged’. The CDA can be sent by email or by fax to ORC and should include sponsor contact information for negotiations. The executed CDA will be returned to the sponsor by either OCC or the PI. A copy of the executed CDA will be maintained by ORC and a copy must be retained in the PI’s research records.
Note: The signature of the PI on a CDA only covers the confidentiality of the PI. Sharing study information with anyone else at Duke is not covered, and the PI in doing so is in breach of the contract and may be held personally responsible.