Confidentiality agreement template clinical trials

A Confidentiality Agreement, also sometimes referred to as a non-disclosure agreement CDA or NDA , is designed to protect the confidential information that may be released between an industry sponsor and the faculty and staff of Yale University so that they can determine whether or not to enter into a subsequent agreement for either a clinical trial CTA or basic research SRA.

CDAs may be one-way or mutual and are generally requested by sponsors prior to disclosing a study protocol or other information which the sponsor considers proprietary. Not all sponsors require a CDA prior to disclosure of confidential information. Upon receipt of a CDA, please send the document, along with the contact information from the originating sponsor, to your OSP contract manager and your GCAT mailbox , so that it can be negotiated with terms consistent with Yale policies and procedures.

You must put a time limit on our obligations. See Clause 1. Either delete the reference to results in the confidentiality clause, or cross-reference our right to publish the results. See Publication Sample Clause 3. Tips: Short form is appropriate where we do not anticipate much exchange of confidential information.

Always include limitations to information marked "confidential. If the PI will receive information from the sponsor or CRO that does not require distribution to other individuals, the PI may sign the agreement on his or her own behalf. When the PI signs as an individual, he or she becomes personally responsible for managing the protected, confidential information and should not disclose or distribute the information to anyone who has not signed a similar NDA with the sponsor or CRO.

Research Management Group. Non-Disclosure Agreements.