About this course
This practical, one-day course provides 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). Topics that are discussed include:
- 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.
The main focus of this course is on helping the drafter and negotiator to navigate the contractual issues.
CTAs raise many issues; within the time available (6 hours teaching) we look at the main issues that, in our experience, tend to arise.
We will mention UK and EU regulatory issues, as they are important when drafting CTAs, and discuss how and why these affect the terms; but this course is 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.
Schedule:
DAY ONE: 09:45 - 13:15
09:45 Introduction to the course;
09:50 Issues that typically arise; regulatory framework (UK and EU) and how this affects CTAs.
11:00 (approx.) 5 mins comfort break
11:05 Other Legal and Drafting issues, including review of NHS CTA
12:00 (approx.) 5 mins comfort break
12:30 Group drafting/negotiation exercises; answers
13:15 (approx.) day one ends
DAY TWO - 10:00 - 13:15
09:45 Agreements to develop medical devices – overview of regulatory issues
10.30 Legal issues affecting trials generally
11:00 (approx.) 5 mins comfort break
11:30 Other types of agreement related to trials, including MTAs and human tissue agreements
12:00 (approx.) 5 mins comfort break
12:15 Further discussion of detailed drafting issues
13:00 Course ends
Who should attend
The course is designed for contracts managers, lawyers and project managers who have had some exposure to CTAs but are not experts and do not have years of experience of negotiating them. We find that attendees are mostly based in universities, hospitals and life-science companies, including CROs.
Preparation for the course?
Although not essential, attendees may find it helpful to read one of the NHS standard clinical trial agreements, such as the mCTA (Primary Care model Clinical Trial Agreement) and the accompanying guidance notes.
Learning Outcomes
At the end of the course, attendees should have an overview of the legal and regulatory environment as it affects the terms of clinical trial agreements (CTAs) and related contract documentation, the main terms of CTAs, the main negotiating issues that arise, the importance of precise drafting, some industry-standard contracts that are used in clinical trials, and the different perspectives of universities, hospitals, sponsors and CROs.
WARNING:
Past experience indicates that people with different expectations and learning requirements sometimes book on this public course. (When run as an in-house course, this doesn’t tend to happen, as we know in advance who will be attending.) So as not to disappoint, we should point out that the course is designed for people who are responsible for negotiating clinical trial agreements, whether as senior executives, contract managers or legal advisers. The focus is on topics that affect contract drafting, including a range of legal issues such as employment status, IP ownership, data protection, and who is taking regulatory responsibility. We look at typical contract wording and the commercial and legal issues that such wording raises.
The course does not, however, attempt to provide detailed training on regulatory compliance. This is a specialist topic in itself. In practice, the speaker finds that clients have their own regulatory specialists who advise on these topics, and whose advice feeds into the drafting of the contract.
