Non-Disclosure Agreement Processing Guide for CTAs

Non-Disclosure Agreements (NDA) and/or Confidential Disclosure Agreements (CDA) are usually prerequisites to a Clinical Trial. For example a pharmaceutical company or a coordinating contract research office (CRO) may want to send a clinical research protocol to the investigator so they can decide whether or not to participate in the trial. Prior to receipt of such a document a NDA/CDA needs to be executed by both parties. For the protection of the University and Investigators involved, all NDA/CDA’s must be reviewed, approved and executed by the legal authorities at the Division of Sponsored Programs (DSP).

To process your NDA/CDA for DSP’s approval, please follow the steps below.

  1. Send the NDA/CDA you receive to the RAC Office or DSP’s Proposal Processing Office, as appropriate, using UFIRST – Agreements.
  2. Include the name, address, telephone number and email address of your contact.
  3. Please inform us of any concerns you may have about the NDA/CDA.
  4. RAC for College of Medicine faculty and DSP for others will review the agreement, negotiate the terms (if needed), collect DSP signature and return it to the other party. If the Investigator’s signature is needed to acknowledge the terms of the agreement, RAC or DSP will collect such signature prior to signing and returning the NDA/CDA to the company.
  5. Once DSP receives a fully executed NDA/CDA, a copy will be sent to the Investigator and the exchange of confidential information can begin.