Confidentiality Agreement In Clinical Trials

NDA is not linked to an industry-sponsored clinical trial If sp receives a fully executed CDA, the agreement will be processed and a copy will be 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. In addition, Stanford uses pre-negotiated master`s NDAS with a few frequent sponsors of clinical trials to reduce negotiation time, protect Stanford`s interests, and maintain Stanford`s academic guidelines. 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. Industrial sponsors of clinical trials may wish to send their proprietary/confidential information about a drug or device under development (e.g. B study protocol, trial brochure) to a principal investigator potential (PI) so that they can decide if they wish to participate in a study. 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. An NDA can also be called a Confidential Disclosure Agreement (CDA) or Confidentiality Agreement. 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 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). THE CDAs/NDAs must be submitted to the CTO for negotiation and implementation on behalf of the university and the IP. Add the missing exclusions.

See example of confidentiality Clause 1.1, paragraphs a to f. 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. There are two types of CDAs/NDAs: (a) single-use CDAs/DNNs, in which the company transmits confidential information to the university; b) Two-way CDAs/NDAs, in which the company and the university (through their IPs) disclose confidential/proprietary information. . . .

This entry was posted in Non classé by karen. Bookmark the permalink.