Confidentiality Agreements in Clinical Trials: A Brief Look at the Site CDA.

Many articles have been written about Clinical Trial Agreements (the “CTA”), but the Confidential Disclosure Agreement with the clinical trial site (“Site CDA”) is often the first legal agreement executed in furtherance of the clinical trial.  Even if you understand typical commercial non-use and non-disclosure agreements, the Site CDA presents many unique challenges. Some of these challenges include:

Who are the parties to the Site CDA?

It’s not always clear who should be the parties when a Principal Investigator is an independent consultant and not an employee of the research site or when other parties are involved in the clinical trial such as a Site Management Organization (“SMO”).

Is the CDA between the Site and Contact Research Organization (“CRO”) or with the Sponsor?

Sometimes a CRO will be the party to the Site CDA and the Sponsor will be removed from the direct contractual relationship.  However, since Sponsor confidential information is often being disclosed to the Site from the CRO, this structure often presents different risks than when the Sponsor contracts directly with the site.  These risks have the potential to flow through to the CTA and to other ancillary agreements such as Letters of Indemnity.

Should the CDA be “one way” or “bilateral”?

What if a SMO is involved or a Sponsor collaborator?  How do you turn a bilateral CDA into a multi-lateral one?  These questions often require revising a few key sections of the Site CDA but also may present challenges depending on the parties and the nature of information disclosed (for example, if trade secrets are involved or some data that is prohibited from being shared because of a license restriction).

What is the “Purpose” of the Site CDA?

The Site CDA is supposed to be limited in scope but often the purpose is not clearly defined.  Also, since the purpose of  the Site CDA is limited, how do you account for the Site CDA once the parties execute a CTA?

What information is confidential and who can receive it?

Often, and especially with academic research sites such as major State Universities, the site will try to restrict what is defined as “confidential information.”  This presents both operational challenges around how much information to disclose in furtherance of the Purpose (discussed above) at this early stage and also legal challenges around defining what specific items constitute confidential information.

What kind of information is confidential?

For example, does the Site CDA mean that a CRO conference call with the Site that discusses Sponsor data is confidential?  What about a budget?  There are often ways to address this clause that meet both the Site and Sponsor / CRO requirements.

How long will the parties be bound by obligations of confidentiality and non disclosure in the Site CDA?

The length of time may depend on many factors that the clinical research team is not involved at the Sponsor management level such as protection of intellectual property for the study drug.

Who can access the Sponsor Confidential Information and is the Site responsible for any unauthorized access to this information?

This may become an issue depending on many factors including without limit the type of information disclosed in connection with the Purpose, or operational risks including when the Site has a SMO working with it or with many consultants spread across the globe in high risk countries.

How do you handle changes to the Site CDA?

Many Sites or other parties (e.g. a SMO) will edit the form of Site CDA provided by either the Sponsor or CRO.  Some of these changes will happen more often than others and so handling these kinds of changes can be implemented in a “Guidance Document,” containing specific fall back text that has been reviewed and approved by legal counsel.

What do you do when a state academic Site adds language about State “open records” law or similar?

These issues come up often with certain sites and in many cases, if a site makes a change to the Site CDA around open records, they will often make one to the CTA once it is negotiated.  It is helpful to have a unified strategy to this type of change.

Please continue to check back at this blog as we post more articles around the legal aspects of clinical trials and contracting.

© 2020 Ken Linsk