For industry-sponsored clinical trials, the sponsor or contract research organization (CRO) typically requires Stanford or the PI to enter into a Non-Disclosure Agreement (NDA) before sharing the study protocol and other proprietary documents. The NDA protects the confidential nature of the trial details. An NDA also may be referred to as a Confidential Disclosure Agreement (CDA) or Confidentiality Agreement.
Stanford's policy allows researchers to sign NDAs in their individual capacity. PIs and other study team members do not have authority to sign on behalf of Stanford University. Research Management Group (RMG) Clinical Trial Contract Officers (CT CO) have designated signature authority to negotiate and sign NDAs on behalf of Stanford University.
The sponsor or CRO often provides its own NDA template; however, Stanford prefers to use the Accelerated Confidential Disclosure Agreement (ACDA), which a team of academic medical centers, universities (including Stanford), industry sponsors and CROs developed to reduce time spent negotiating NDAs. Additionally, with some frequent clinical trial sponsors, Stanford uses pre-negotiated Master NDAs to reduce negotiation time, protect Stanford’s interests and uphold Stanford’s academic policies.
- RMG provides guidance on NDAs related to clinical trials.
- The Industrial Contracts Office provides guidance on NDAs related to industry-sponsored research.
- The Office of Research Administration provides guidance on NDAs related to non-profit or government-sponsored projects.
NDA is not related to an industry-sponsored clinical trial
If the PI will receive information from the sponsor or CRO that does not require distribution to other individuals, the PI may sign the agreement on his or her own behalf. When the PI signs as an individual, he or she becomes personally responsible for managing the protected, confidential information and should not disclose or distribute the information to anyone who has not signed a similar NDA with the sponsor or CRO.
How to Process an Industry-Sponsored Clinical Trial NDA
- If the sponsor or CRO requires an institutional signature on an NDA, the PI or department sends to email@example.com either:
- the NDA provided by the sponsor, or
- an email request to have Clinical Trial Research Management Group (CT RMG) send an NDA template to the sponsor or CRO. Include the name and email address of the industry sponsor or CRO contact in the request.
- CT RMG confirms receipt of the documents received and assigns the NDA to a CT CO.
- The CT CO negotiates and approves the NDA.
- After negotiating the NDA, the CT CO sends the NDA to the PI to sign as having “read and understood” his or her obligations under the NDA.
- The CT CO signs the NDA and returns it to the sponsor or CRO for signature.
- After all parties have signed the NDA, the CT CO returns a copy of the agreement to the PI, with instructions on how to initiate the clinical trial Study Set-up Process.