A Confidential Disclosure Agreement (CDA) is often a precursor to a clinical trial. A company may want to send a protocol to the investigator so that they can decide whether or not to participate in the study. The protocol may contain sensitive information that the company needs to protect. Once a sponsor or contract research organization (CRO) has identified the UTHSCSA as a potential site for a clinical trial, a CDA can be sent to the Principal Investigator (P.I.) for signature. To protect the Health Sciences Centre and the investigator, this agreement must be reviewed and approved by OSP. CDAs are usually simple, but require few changes. Some CDAs may contain requests that the PSO cannot satisfy. For example, as an educational institution in the state of Texas, the Health Science Center cannot submit to the laws of other states. If the I.P. signs CDA without verification and signature from the Health Sciences Centre, P.I. will assume full responsibility and the Health Sciences Centre will not be able to support it if CDA`s conditions are violated. Please note that some proponents do not require a CDA. As with other types of sponsored project applications and agreements, CDAs must be routed through the user interface channels for ministry and college approval before being reviewed by the DSP.
The routing process begins electronically by filling out a form in the University of Iowa Research Information System (UIRIS). Therefore, you need UIRIS access to submit a CDA for the DSP exam. CDAs/NDAs are reviewed by several offices at the University of Pittsburgh. The content and purpose of these agreements determine which head office verifies the language and sign on behalf of the university: A CDA or NDA guarantees that the parties will protect any confidential information disclosed from unauthorized use or disclosure. A CDA or NDA is usually limited to a certain period of time. I would like to submit: Non-disclosure agreement for review If the principal investigator receives information from the sponsor or the CRO that does not require disclosure to others, the principal investigator may sign the agreement on his or her own behalf. If the PR signs as an individual, he/she will be personally responsible for the management of the protected and confidential information and should not disclose or distribute the information to anyone who has not signed a similar confidentiality agreement with the sponsor or cro. A Confidential Disclosure Agreement (CDA), also known as a Non-Disclosure Agreement (NDA) or Non-Disclosure Agreement, is a legal agreement between at least two parties that describes information that the parties wish to share with each other for specific evaluation purposes, but wish to restrict wider use and dissemination.
The parties agree not to disclose non-public information covered by the Agreement. CDAs are typically performed when two parties are considering a relationship or collaboration and must understand the other party`s processes, methods, or technologies solely for the purpose of assessing the potential of a future relationship. Where the fully executed confidentiality agreement is available, the sponsor shall forward the study protocol, the investigator`s brochure, the draft budget, the clinical trial agreement and other study documents for review and review by the investigator. Confidential Disclosure Agreements (CDAs) – also known as confidentiality agreements and non-disclosure agreements – are binding contracts to ensure the disclosure or exchange of confidential information. Industry clinical trial sponsors may wish to submit their proprietary or confidential information about a drug or product under development (e.g., B, study protocol, investigator`s brochure) to a potential principal investigator so that they can make a decision about their participation in a study. The sponsor or CRO often provides its own NDA template. However, Stanford prefers to use the Accelerated Confidential Disclosure Agreement (ACDA), which a team of academic medical centers, universities (including Stanford), industry sponsors, and CRO has developed to reduce the time it takes to negotiate NDAs. In addition, Stanford uses pre-negotiated master`s NDAs with certain sponsors of frequent clinical trials to shorten negotiation time, protect Stanford`s interests, and comply with Stanford academic guidelines.
In the case of industry-sponsored clinical trials, the sponsor often requires a signed CDA or NDA before sharing confidential information (e.g., B study protocol, study feasibility questionnaire or investigator brochures) with an investigator or institution. Often, an investigator uses disclosure and shared information to assess whether they are interested, have the right patient population, and other requirements to participate in the study. Confidentiality agreements/non-disclosure agreements (CDAs and NDAs) are used to establish roles and responsibilities for the disclosure and protection of confidential information. Before an investigator and industry sponsor begin sharing information about a clinical trial, a non-disclosure or non-disclosure agreement (NDA or CDA) is often requested. This protects proprietary information so that the investigator and sponsor can freely discuss a protocol in detail. The confidentiality agreement (ADC) or the non-disclosure agreement (ADN) are essentially identical. They refer to an agreement between two or more parties to protect the exchange of confidential information * Can also be called a confidentiality agreement or a non-disclosure agreement. The NDA is not linked to an industry-sponsored clinical trial We use a CDA or NDA to protect confidential information.
In the case of an industry-sponsored clinical trial, a CDA or NDA requires the investigator, as well as any academic staff who share the information, to keep the information confidential for a specified period of time and use the information only to determine an interest in participating in the study. For industry-sponsored clinical trials, the sponsor or contract research organization (CRO) generally requires Stanford or the principal investigator to enter into a non-disclosure agreement (NDA) before sharing the study protocol and other proprietary documents. The NDA protects the confidentiality of study details. A confidentiality agreement can also be called a confidential disclosure agreement (CDA) or a confidentiality agreement. For industry-sponsored clinical trials, the contract administrator reviews a CDA within one week and returns it to the sponsor or clinical research organization working on behalf of the sponsor. CDAs must be submitted in Click on the Agreements tab. Negotiations can take some time, but CDAs can usually be quickly reversed if everyone is able to start discussions related to the study. Once the terms of the CDA have been negotiated, the PSO sends 2 original CDAs to the P.I. Once you have signed, return both CDAs to OSP for signature. The PSO sends the two originals of the CDA to the proponent. Once OSP receives a fully executed CDA, a copy of your files is sent to the P.I. An EVPRI contract specialist negotiates the terms of the NDA and then obtains the signatures of the principal investigator and authorized representatives of UdeL and the sponsor.
Stanford`s policy allows researchers to sign NDAs on an individual basis. Principal investigators and other members of the study team do not have the authority to sign on behalf of Stanford University. The Research Management Group`s (RMG) Clinical Trials Contracting Officers (CT CO) have designated signing authority to negotiate and sign NDAs on behalf of Stanford University. *Subject to the sponsor`s requirements and/or changes to the PSO procedure. If you have questions about CCA for other types of studies, please refer to the Confidential Disclosure Agreement Application Form. There are two types of ADC/NDA: a) disposable CDAs/NDAs where the company transmits confidential information to the university; b) Bidirectional CDA/NDA where the company and the university (through their IPs) disclose confidential/proprietary information to each other. In True 2.0, there is a CDA delivery workflow. Please follow the screenshots of CDA`s submission for assistance in this process. CDAs/NDAs must be submitted to the CTO for negotiation and execution on behalf of the university and the RESEARCHER.
PSD will review the original CDA and negotiate appropriate terms with the proponent if necessary. Once the terms and conditions of the CDA have been agreed, the CSP sends a copy to the Principal Investigator (or the researcher working with the PI) for signature by the Principal Investigator. .
