Confidentiality Agreement Clinical Trials

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. 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. Once the terms of the CDA have been negotiated, SP will execute the agreement and send the partially executed agreement to the sponsor or CRO for signature. Once SP receives a fully executed CDA, the agreement is processed and a copy is sent to the PI for its files. NDA is not tied to an industry-sponsored clinical trial Make sure the time frame is reasonable. Periods of 1 to 5 years are the norm, although in rare cases 7 years have been accepted with the specific agreement of the main controller.

Longer periods must be justified by a particular reason that you document in your files. For example, a license agreement with the study material in which the sponsor participates, which requires longer confidentiality. 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. 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. 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. . .