Confidentiality Agreement In Clinical Research
Written by trasfoco in Sin categoría on septiembre 15, 2021
Once SP receives a fully executed CDA, the agreement is processed and a copy is sent to the PI for its files. 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. 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. 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. 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.
NDA is not linked to an industry-sponsored clinical trial 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 the 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. 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. 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. A Confidential Disclosure Agreement (CDA) is often a precursor to a clinical trial.
A company may wish to send a report to the examiner so that it can decide whether it wishes to participate in the study. The protocol may contain confidential information that the company must protect. Once a sponsor or contract research organization (CRO) has identified UTHSCSA as a potential site for a clinical trial, a CDA can be sent for signature to the Lead Controller (P.I.). To protect the Health Science Center and the examiner, this agreement must be verified and approved by OSP. CDAs are generally simple and require few modifications; Some PDAs may contain queries that OSP cannot fill. For example, the Health Science Center, as an educational institution in the state of Texas, cannot submit to the laws of other states. . . .