Execution of Confidential Disclosure Agreements (CDA)
A Confidential Disclosure Agreement (CDA) is often a precursor to a Clinical Trial. A company may want to send a protocol to the investigator so that he/she can decide whether to participate in the trial. The protocol may have confidential information that the company needs to safeguard. Once a sponsor or Contract Research Organization (CRO) has identified UTHSCSA as a potential site for a clinical trial, a CDA may be sent to the principal investigator (P.I.) to sign. In order to protect the Health Science Center and the investigator, this agreement must be reviewed and approved by OSP. CDA's are usually straightforward and require little change however; some CDA's can include requests that OSP cannot honor. For example, as a State of Texas educational institution, the Health Science Center cannot subject itself to the laws of other states. If the P.I. signs the CDA without Health Science Center review and signature, the P.I. will incur sole responsibility and the Health Science Center will be unable to support him in the event that the terms of the CDA are breached. Please note that some sponsors do not require a CDA.
All incoming CDA’s need to be negotiated and signed by OSP. To process your CDA, please provide the following:
- Send a copy of the CDA that you receive from the discloser to OSP. Agreement should be sent via electronically to firstname.lastname@example.org.
- Include the name, address, telephone number and email address of your contact.
- If needed, include a note with any concerns you may have about the CDA.
Once the terms of the CDA have been negotiated, OSP will send 2 original CDA's to the P.I. for signature. Once signed, return both CDA's to OSP for University signature. The OSP will send both originals of the CDA to the sponsor. Once OSP receives a fully executed CDA, a copy will be sent to the P.I. for your files.