When conducting Industry Sponsored Clinical Trials the "Sponsor" and "Investigative Site" often seek to complete a Confidentiality Agreement (CDA) that allows each party to share information regarding non-public information that is to remain confidential. This is often proprietary information pertaining to an Investigational Drug, Investigational Device and/or study an executed confidentiality agreement is finalized.
A signed confidentiality agreement between 2 parties allows and investigator to evaluate the protocol to determine feasibility and interest in conducting the clinical trial at Temple University. The terms of the agreement assure sponsor’s that its confidential information is protected from unauthorized disclosure for a specified period of time.
For more information regarding Confidentiality Agreements you may contact the Office of Clinical Trials at (215) 707-9190 or e-mail to oct@temple.edu.
Confidentiality Agreement are typically straight forward, however there are common pitfalls or language that Temple University will not agree to with a sponsor. Listed below is practical advice for handling a Confidentiality Agreement at Temple University.
Party to the Agreement:
Temple University of the Commonwealth System of Higher Education
Practical Information for Handling the Confidentiality Agreement
Ask sponsor if a Confidentiality Agreement is required prior to sharing study specific information.
If Yes, request a copy of the sponsor confidentiality agreement for review. Investigators and staff should not sign a Confidentiality Agreement with a sponsor in which the party listed on the agreement is Temple University.
Send the Confidentiality Agreement to the Office of Clinical Trials for review, negotiation and signatory process.
Common Pitfalls
Overly broad, going beyond the purpose of protecting against disclosure the sponsor's protocol and other confidential information.
An overly broad confidentiality agreement may extend into matters such as requiring confidentiality of the trial results or restricting your freedom to publish .
May require that you disclose your own confidential information to the sponsor.
May bind you for an excessive period of time.
Such provisions may also be inconsistent with the Temple’s policies and may expose you to legal risks contrary to your best interests.
State of Law with oversight of the Agreement may not be Pennsylvania. This language should be amended to state Pennsylvania or the language should remain silent.
Liabilities may also be detailed in the document regarding inappropriate disclosure that may expose you to legal risks contrary to your best interest.
