Clinical Trials Confidentiality Agreement

By 14 septiembre, 2021Sin categoría

Make sure the period 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. Once SP receives a fully executed CDA, the agreement is processed and a copy is sent to the PI for its files. The NDA is not linked to an industry-sponsored clinical trial If the fully executed NDA is in place, the sponsor forwards the study protocol, trial brochure, draft budget, clinical trial agreement and other study documents for verification and verification by the trial physician. Either remove the reference to the results in the confidentiality clause or refer to our right to publish the results. See sample publication, section 3. 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 PI signs as an individual, it becomes personally responsible for the management of the protected confidential information and should not disclose or distribute the information to persons who have not signed a similar NDA with the sponsor or cro….