Confidentiality Agreement Clinical Research

Once a sponsor or contract research organization (CRO) has identified the UCI as a potential site for a clinical trial, a CDA can be sent to the IP. To protect the university and IP, all CDA companies that require a university signature must be controlled, negotiated and executed by Sponsored Projects (SP). Make sure the period is appropriate. Periods of 1-5 years are standard, although 7 years have been accepted in rare cases with the specific agreement of the lead investigator. Longer periods of time must be justified by a particular reason that you document in your files. For example, a licensing agreement with the study material in which the proponent participates and which requires a longer determination of confidentiality. If PI receives information from the sponsor or CRO that does not require distribution to others, the IP may sign the agreement on its own behalf. If PI signs as an individual, he will be personally responsible for the management of protected confidential information and should not disclose or disclose the information to individuals who have not signed a similar NOA with the sponsor or the CRO. Delete the reference to the results of the confidentiality clause or refer to our right to publish the results. See example of Clause 3 publication. The NDA is not related to an industry-sponsored clinical study of Stanford policy that allows researchers to sign NDAs in their individual capacity. IPs and other members of the study team are not eligible to sign on behalf of Stanford University.

Clinical Trial Contract Officers (CT CO) of the Research Management Group (RMG) have designated the signature authority for the negotiation and signing of the NDAs on behalf of Stanford University. Sponsors of the clinical trial industry may send their proprietary/confidential information about a developed drug or device (e.B. study protocol, test brochure) to a potential primary investigator (PI) to enable them to make a decision on participation in a study. Once the terms of the CDA have been negotiated, SP will execute the agreement and send the partially executed agreement to the signing of the sponsor or CRO. As soon as SP receives a fully executed CDA, the agreement is processed and a copy of its files is sent to IP. The sponsor or cro often provides its own NOA model; Stanford, however, prefers to use the Accelerated Confidential Disclosure Agreement (ACDA), which was developed by a team of academic medical centers, universities (including Stanford), industry sponsors and CROs to reduce NDAs trading time. In addition, Stanford uses pre-negotiated NDAs masters with a few frequent clinical trial sponsors to reduce trading time, protect Stanford`s interests and support Stanford`s academic policy. For industry-sponsored clinical trials, the sponsored or contracted research organization (CRO) generally requires Stanford or IP to enter into a non-discloser agreement (NDA) before sharing the study protocol and other proprietary documents. The NDA protects the confidentiality of the details of the procedure. An NOA can also be referred to as a Confidential Disclosure Agreement (CDA) or confidentiality agreement.

Confidentiality agreements/non-disclosure agreements (CDAs – NDAs) are used to define the roles and responsibilities for disclosing and protecting confidential information. A company can send a protocol to the lead investigator (PI) so that it can decide whether it wants to participate in the study. The protocol may have confidential information that the company must protect. The mechanism for protecting confidential information is the implementation of a Confidential Disclosure Agreement (CDA).