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CONFIDENTIAL DISCLOSURE AGREEMENTS
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:
1. Department Administrator (DA) emails Office of Clinical Research (OCR)* using standard subject line:
“CDA: [PI] / [sponsor and/or CRO] / [CDA topic]”
With relevant attachment, ensuring the CDA (preferably in Microsoft Word), sponsor/CRO contact information and PI request/concurrence to process is included in the text or attachments.
2. OCR* reviews CDA and forwards email, with OCR concurrence, to CDA@lists.uchicago.edu, with cc: to appropriate Grants & Contracts Manager (GCM).
3. GCM negotiates and obtains Associate Vice President for Research Administration signature on CDA.
4. GCM distributes fully-executed CDA.
*If the CDA is not related to a clinical trial, the DA sends emails directly to CDA@lists.uchicago.edu with cc: to appropriate GCM, and the CDA will not be reviewed, approved, or distributed to OCR.
