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:
1) Send a copy of the CDA that you receive
from the discloser to OSP. Agreement should be sent via electronically
to greenc@uthscsa.edu.
2) Include the name, address, telephone number and email address of
your contact.
3) 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.
Disclosure Form:
Confidential Disclosure
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