A company may want to send a protocol to the Principal Investigator (PI) so that he/she can decide whether to participate in the trial. The protocol may have confidential information that the company needs to safeguard. The mechanism to protect the confidential information is the execution of a Confidential Disclosure Agreement (CDA). Please note that some sponsors do not require a CDA prior to releasing a protocol.
Once a sponsor or Contract Research Organization (CRO) has identified UCI as a potential site for a clinical trial, a CDA may be sent to the Principal Investigator (PI). In order to protect the University and the PI, all incoming CDA’s requiring University signature need to be reviewed, negotiated and executed by Sponsored Projects (SP).
CDAs are usually straightforward and require little negotiation; however, some CDAs can include requests that SP cannot honor. For example, as a State of California educational institution, the University cannot subject itself to the laws of other states.
To process the CDA:
- Send the CDA to your SP Principal Contract Officer.
- Include the name, address, telephone number and email address of the sponsor or CRO’s contact.
- If needed, include a note with any concerns about the CDA.
Once the terms of the CDA have been negotiated, SP will execute the agreement and send the partially executed agreements to the sponsor or CRO for signature.Once SP receives a fully executed CDA, the Agreement will be processed and a copy will be sent to the PI for his/her files.