If the Principal Investigator receives information from the Sponsor or the CRO that does not require disclosure to others, the Principal Investigator may sign the Agreement on their own behalf. If the PR signs as an individual, he/she will be personally responsible for the management of the protected and confidential information and should not disclose or distribute the information to anyone who has not signed a similar confidentiality agreement with the sponsor or cro. As a general rule, these areas should not be covered by a CDA, as a CDA should normally only allow the use of the information provided for evaluation purposes. The actual implementation of the project should be the subject of a separate contract, by .B. in a clinical trial agreement or in a sponsored research agreement. The adoption of such clauses in a CDA may prevent the researcher or university from freely pursuing its research and results. Perhaps, depending on what the terms of the contract look like. It`s always a good idea to check first, as some agreements strictly limit disclosure to the contact person named in the agreement – usually the lead investigator. A Confidential Disclosure Agreement (CDA), also known as a Non-Disclosure Agreement (NDA), is a legal contract between at least two parties that describes confidential information that the parties wish to share with each other for specific purposes, but who wish to restrict access by third parties. As a result, a CDA protects non-public information about research and commercial activities from disclosure or use by third parties. CDAs are usually signed when two institutions, companies, individuals or other companies plan to cooperate and need to consult or exchange confidential information. You should consider the need for such an agreement whenever you disclose information that is not generally publicly available and you wish to restrict the use or dissemination by the other party.

For example, sending a study of your design or protocol to a pharmaceutical company, giving a talk to a pharmaceutical company to discuss your unpublished research, or sharing a potentially patentable idea with an employee outside the university as part of a grant application. 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 CRO has developed to reduce the time it takes to negotiate NDAs. In addition, Stanford uses pre-negotiated master`s NDAs with certain sponsors of frequent clinical trials to shorten negotiation time, protect Stanford`s interests, and comply with Stanford academic guidelines. No. A CDA should not be used to cover the actual conduct of the research, as this would limit the ability of the university and the researcher to publish or otherwise disseminate the results and findings obtained through the research. Typically, Brown University includes CDAs that are unilateral, i.e. extroverted, so our findings may be shared with third parties for limited and defined purposes prior to publication. Stanford`s policy allows researchers to sign NDAs on an individual basis. Principal investigators and other members of the study team do not have the authority to sign on behalf of Stanford University. The Research Management Group`s (RMG) Clinical Trials Contracting Officers (CT CO) have designated signing authority to negotiate and sign NDAs on behalf of Stanford University.

The NDA is not tied to an industry-sponsored clinical trial Typically, confidentiality obligations can range from 3 to 5 years, in some cases they can last up to 7 years or more, depending on the agreement. In any case, it must be carefully checked by the IP. Using Brown CDA templates will greatly simplify the process. It can be submitted to the other party within 24 hours. The use of the other party`s submission delays the execution of the document, as negotiations on certain provisions are usually necessary. For industry-sponsored clinical trials, the sponsor or contract research organization (CRO) generally requires Stanford or the principal investigator to enter into a non-disclosure agreement (NDA) before sharing the study protocol and other proprietary documents. The NDA protects the confidentiality of study details. A confidentiality agreement can also be called a confidential disclosure agreement (CDA) or a confidentiality agreement. .