Drafting and Negotiating Clinical Trial Agreements

About this course This practical, one-day course provided a detailed discussion of the legal, regulatory, drafting and practice issues that arise when drafting and negotiating clinical trial agreements (CTAs) and other contractual documents that are encountered when clinical trials are run, e.g. agreements between a sponsor and a clinical research organisation (CRO). The main focus of this course was on helping the drafter and negotiator to navigate the contractual issues. CTAs raise many issues; within the time available (6 hours teaching) we looked at the main issues that, in our experience, tend to arise. We explored UK and EU regulatory issues, as they are important when drafting CTAs, and discussed how and why these affect the terms; but this course was not intended to teach the complex legal framework for the various types of regulated study. Our experience is that clients employ or consult with a regulatory expert when setting up clinical trials, and we work with them to ensure that the appropriate regulatory terms for the individual trial are reflected in the terms of the agreement. You gained the following understanding by attending this course: • What makes CTAs different from other professional services agreements. • The European regulatory framework for trials and how this affects the terms of agreements. • Other laws and regulations affecting CTAs, including data protection, freedom of information, “sunshine” laws, and many other topics. • Standard agreements – governmental, company, etc: when are they used, when are they not; and how are they revised. • Drafting and negotiation issues. • Practical aspects of working with colleagues to get the agreement right. • Other agreements and documents used in clinical trials.