CDA是管理接收和/或披露机密信息的当事方义务的合同。例如，行业发起人可能希望向PI披露研究方案以进行可行性审查，但该协议可能包括必须保护的机密信息。这些协议有时称为“不披露协议”（NDA）。CDA/NDA的类型如下：

• 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

当PI向行业或学术机构披露机密信息时，将涉及研究人员发起的CDA，但他们没有向休斯顿Uthealth披露任何机密信息。这将被视为单向CDA。

PROCESS

制药/设备公司通常会将CDA/NDA发送到PI或部门进行签名。PI/部门将将CDA/NDA转发到SPA，以协商协议的法律条款。

DEPARTMENT TASKS/RESPONSIBILITIES

• Submit Word file of Contract to SPA by emailing it tocrf@uth.tmc.edu
• Route the final agreement for PI signature - submit to SPA

SPA TASKS/RESPONSIBILITIES

• Determine whether the agreement is a Sponsor initiated CDA/NDA, Investigator initiated CDA/NDA, or a mutual CDA/NDA.
• 如果该协议是共同协议，请确定PI是否计划向赞助商提供机密信息。
• 如果PI不打算向赞助商提供机密信息，请要求赞助商发送单程协议。
• 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.
• 代表PI和大学与合作者协商协议的法律条款。
• Obtain PI Read and Understood approval (either signature or electronic approval).
• 将最终协议与PI签名（如果适用）供机构签署
• SPA will send to collaborator for full execution
• SPA will assure PI has a copy of fully executed agreement and will retain a copy for institutional record.