Confidential Disclosure Agreements (CDA)
A potential sponsor may want to send a protocol to the Principal Investigator (PI), so that he/she can decide whether to participate in the clinical trial. In the event the protocol contains information that the potential sponsor considers to be confidential or proprietary, it is not uncommon for such potential sponsor to request the execution of a confidential disclosure agreement ("CDA"), prior to the release of the protocol, as a means of protecting the disclosure of such information. (Note: CDAs are sometimes referred to as non-disclosure agreements ("NDAs").)
Should a PI receive a CDA requiring University signature, it will need to be reviewed, negotiated, and executed by Sponsored Programs Administration (SPA). CDA's are usually straightforward and require little negotiation; however, some CDA's can include requests that are contrary to UC policy and, thereby, require more time to resolve.
To process a CDA:
- Email the CDA to ClinicalTrials@ucr.edu (with a copy to your departmental analyst);
- Include the name, address, telephone number, and email address of the sponsor's (or that of any applicable contract research organization, aka "CRO") point of contact;
- Include the name, address, telephone number, and email address of the subcontractor's (i.e., the entity whose facility and/or clinical support services would be utilized by UCR in the conduct of the clinical trial) point of contract. Such potential subcontractor would also need to sign a CDA prior to receiving a copy of the protocol for review; and
- Include a note with any concerns about the CDA, if any.
Once the terms of the CDA have been negotiated, SPA and the sponsor (or CRO, if applicable) will execute the agreement. SPA will also coordinate the execution of the CDA for the entity that will be assisting in the feasibility assessment. (Note: The PI may be requested to sign an acknowledgement block indicating his/her willingness to comply with the terms of the CDA.) Thereafter, the fully executed CDA will be processed by SPA and a copy will be sent to the PI and his/her departmental analyst.