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. 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 A CDA or NDA ensures that the parties will protect all confidential information disclosed from unauthorized use or disclosure. A CDA or NDA is usually limited to a certain period of time. The University Library has a list of authorized signatories who are exempt from liability by the Research Foundation. Please do not sign the CDA yourself, as investigators are not signing authorities. 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. 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. When a researcher submits a proposal to an industry partner who requests support (funding, drugs or other material) for an investigator-initiated study, they usually establish an ADC or NDA before submitting the proposal. This protects both the researcher`s ideas and the study design. In this case, the examiner may need to initiate the ADC or NDA using the standard UB application form available online. If you have any questions about CDAs for other types of studies, please read the Confidential Disclosure Agreement Application Form. .