A CDA is a contract governing the obligations of the parties who receive and/or disclose confidential information. For example, an industry sponsor may wish to disclose a study protocol to a PI for a feasibility review but the protocol may include confidential information that must be safeguarded. These agreements are sometimes referred to as, “Non-Disclosure Agreements” (NDA). The types of CDAs/NDAs are described below:

• Sponsor-initiated CDA

 A Sponsor-initiated CDA is required prior to a sponsor releasing confidential information, such as a protocol, to a PI. The terms of the CDA govern the PI’s obligations of confidentiality with respect to the information disclosed. The CDA also protects UTHealth Houston when it is a party to the agreement. This would be considered a one-way CDA.

• Mutual Disclosure CDA

A Mutual Disclosure CDA is entered into when both industry sponsor or academic institution and UTHealth Houston exchange confidential information to determine a business or research relationship. For example, a PI may disclose a protocol he or she designed to an industry sponsor to see whether it will provide a drug or device for the study and the sponsor may share proprietary information about the drug or device. This would be considered a mutual CDA. Mutual CDAs are negotiated through the Office of Technology Management

•  Investigator-initiated CDA

 An Investigator-initiated CDA is entered into when a PI discloses confidential information to industry or an academic institution but they are not disclosing any confidential information to UTHealth Houston. This would be considered a one-way CDA.

PROCESS

The pharma/device company will generally send a CDA/NDA to the PI or the department for signature. The PI/department will forward the CDA/NDA to SPA for the negotiation of the legal terms of the agreement.

DEPARTMENT TASKS/RESPONSIBILITIES

• Submit Word file of Contract to SPA in START
• PI signature - submit to SPA (Or, if applicable replies to SPA contract analyst with “Read and understood” attestation.)

SPA TASKS/RESPONSIBILITIES

• SPA Intake will route CDA/NDA to appliable contract analyst in SPA.
• Determine whether the agreement is a Sponsor initiated CDA/NDA, Investigator initiated CDA/NDA, or a mutual CDA/NDA.
• If the agreement is a mutual agreement, determine whether PI plans to provide confidential information to the sponsor.
• If the PI does not plan to provide confidential information to the sponsor, ask the sponsor to send a one-way agreement.
• If the PI does plan to provide confidential information to the sponsor, ensure that the CDA/NDA is forwarded to the person/office designated to handle mutual CDA/NDA’s and/or Investigator Initiated CDA/NDAs.
• Negotiate legal terms of the agreement with collaborator on behalf of the PI and the University.
• Obtain PI Read and Understood approval (either signature or electronic approval).
• Route the final agreement with PI signature, if applicable, for institutional signatory to sign
• SPA will send to collaborator for full execution
• SPA will assure a copy of fully executed agreement is uploaded to START for institutional record.