Clinical Research Confidentiality Agreement
By : Nicole -
If the IP receives information from the sponsor or CRO that does not require distribution to other persons, the IP may sign the agreement on its own behalf. If the IP signs as an individual, it becomes personally responsible for the management of the protected confidential information and must not disclose or distribute the information to persons who have not signed a similar NDA with the sponsor or cro. NDA is not linked to an industry-sponsored clinical trial Once a sponsor or contract research organization (CRO) has identified UCI as a potential site for a clinical trial, a CDA can be sent to PI. In order to protect the university and pi, all incoming CDAs requiring an academic signature must be controlled, negotiated and executed by Sponsored Projects (SP). Stanford`s policy allows researchers to sign NDAs in their individual capacity. PIs and other members of the study team are not allowed to sign on behalf of Stanford University. Research Management Group (RMG) Clinical Trial Contract Officers (CT CO) have designated the signing authority for the negotiation and signing of NDAs on behalf of Stanford University. Once SP receives a fully executed CDA, the agreement is processed and a copy is sent to the PI for its files. The sponsor or CRO often provides its own NDA template; However, Stanford prefers to use the Accelerated Confidential Disclosure Agreement (ACDA), which has developed a team of academic medical centers, universities (including Stanford), industry sponsors, and CROs, to reduce the time it takes to negotiate NDAs. For industry-sponsored clinical trials, the sponsor or contract research organization (CRO) requires Stanford or PI to generally enter into a confidentiality agreement (NDA) prior to disclosure of the study protocol and other proprietary documents. The NDA protects the confidentiality of study details….