A confidentiality and non-disclosure agreement (CDA or NDA) is a legal contract that is used to allow the sharing of sensitive information between two parties. It generally includes why the parties are sharing information but does not specify the information itself. Your organisation should have systems in place to store and monitor any confidentiality and non-disclosure agreements.

In most cases the Investigator who has been approached by the Sponsor to run the trial does not have the authority to sign these agreements. It will often be the Chief Executive or their delegate who has legal authority to ratify the confidentiality and non-disclosure agreements on behalf of the organisation where the trial may be carried out. If you are not sure who has the authority to sign these agreements please check with your Research Office.

A CDA/NDA allows a conversation to occur between a commercial Sponsor and your site, allowing them to disclose information about their drug or device, and allowing you to disclose information about your site capability, costs and capacity. A CDA/NDA generally becomes superseded if you and the Sponsor agree to collaborate on a clinical trial, when you sign a Clinical Trial Research Agreement. Institutional CDAs are often negotiated between large institutions, like hospitals, health districts and pharmaceutical companies. These CDA will stay in place often for several years, even if a Clinical Trial Research Agreement is established