Clinical trial sponsors or clinical research organizations (CRO) may wish for the Principal Investigator and/or study staff to review documents such as the Investigator Brochure, Protocol, and other non-public or proprietary information to evaluate the protocol and gauge her or his interest in conducting the clinical trial. The Confidential Disclosure Agreement (CDA)or Non-Disclosure Agreement (NDA) assures the sponsor or CRO that the institution will protect the confidential information against unauthorized disclosure for a period of time. The sponsor or CRO will typically send a copy of their standard CDA. The Principal Investigator may acknowledge her or his responsibilities under the CDA, but only URA can execute the CDA on behalf of institution. Confidential Disclosure Agreements may be executed for non-clinical research, as well.
How to Route a CDA:
Department Administrator (DA) emails CDA directly toCDA@lists.uchicago.edu, with a cc to email@example.com:
'CDA: [PI]/[sponsor and/or CRO]/[CDA topic]'
with relevant attachments, including the CDA (preferably in Microsoft Word), sponsor/CRO contact information and PI request/concurrence to the process.
- GCM distributes fully-executed CDA to PI, DA, and OCR. *If the CDA is not related to a clinical trial, the DA emails the CDA direct toCDA@lists.uchicago.edu with a cc to firstname.lastname@example.org, and the CDA will not be reviewed, approved, or distributed to OCR.
*If the CDA is not related to a clinical trial, the DA sends emails directly to CDA@lists.uchicago.edu, and the CDA will not be reviewed, approved, or distributed to OCR.
The University of Chicago is committed to compliance with all U.S. export control law and regulations. This commitment extends to promoting strict compliance on an on-going basis with terms and conditions in our contracts and agreements. Therefore, an export control clause must be included in all outgoing Material Transfer Agreements (MTA) where UChicago knowingly transfers material that is subject to U.S. export control laws and/or regulations. An export control clause must also be included in all unilateral and bilateral Confidential Disclosure Agreements (CDA), to ensure that the Disclosing Party is aware and acknowledges its responsibility to inform the Recipient when it is transferring/disclosing controlled material, data, or technology.
The export control clause will emphasize each party's existing duty, under U.S. export control laws and regulations, to notify the Recipient of any material, data, or technology that it will transfer/disclose, which is subject to U.S. export control laws and/or regulations. More precisely, the Disclosing Party must agree to provide the relevant export control classification number (ECCN) or the U.S. Munitions List (USML) Category. The clause must also require the Disclosing Party to indemnify the Recipient, if it fails to properly identify and communicate that any such material, data, or technology, is subject to U.S. export control laws and/or regulations.