Overview

This practical online course will help you understand the legal, regulatory, drafting and practice issues that arise when drafting and negotiating clinical trial agreements (CTAs).

It also covers other contractual documents that are encountered when clinical trials are run, such as agreements between a sponsor and a clinical research organisation (CRO).

The main focus of this course is on helping drafters and negotiators navigate contractual issues. It covers:

• legal issues that affect contract drafting, such as employment status, IP ownership, data protection, and who's taking regulatory responsibility
• typical contract wording and the commercial and legal issues that such wording raises.

Course content

Topics that will be 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
• Standard agreements (governmental, company, etc.), when they're used, when they're not used, and how they're 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 course does not provide detailed training on regulatory compliance or the associated complex legal frameworks.

Who this course is for

This course is for people who are responsible for negotiating clinical trial agreements, such as:

• senior executives
• contract managers
• lawyers or legal advisers
• project managers

You should have had some exposure to CTAs, but we don't expect you to be an expert or have years of experience of negotiating CTAs.

Attendees are usually based in universities, hospitals and life-science companies, including CROs.

Teaching and structure 

This course is run online over 2 consecutive days. You'll need to attend from 9.45am to 1.15pm each day. 

You'll need to download Zoom to your computer or use the online version of Zoom. You'll be sent the meeting id number and password on the Friday before your course.

You'll be able to access course materials via a SharePoint site.

Learning outcomes

By the end of the course, you should have a good understanding of:

• the legal and regulatory environment as it affects the terms of 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
• different perspectives of universities, hospitals, sponsors and CROs

Pre-course preparation

Although not essential, you may find it helpful to read one of the NHS standard clinical trial agreements, such as the Primary Care model Clinical Trial Agreement (mCTA) and the accompanying guidance notes.

Costs and concessions

The standard price is £600.

A discounted fee of £510 is available for:

• UCL Alumni
• UCL Institute of Brand and Innovation Law sponsoring firms
• group bookings

Course team

Mark Anderson

Mark is a practising solicitor, who is recommended in Chambers Directory for both life science transactions and IP. He's recommended in the international guide, IAM Patent 1000, as a leading UK lawyer in the field of IP licensing. His blog on IP contracts, IP Draughts, was made a member of the Blawg100 by the American Bar Association in 2012. He's a Certified Licensing Professional (a qualification established by the Licensing Executives Society (US and Canada)) and a Registered Technology Transfer Professional.

He's run CPD courses on IP and contract subjects since the 1990s. He's a visiting lecturer at the UCL Faculty of Laws, and is the course director of a 5-day course, Intellectual Property Transactions: Law and Practice, which is run by UCL’s Institute of Brand and Innovation Law. This course has won two awards: a Law Society Excellence Award (Highly Commended) in the Learning and Development category, and a UCL Provost’s Teaching Award.

Course information last modified: 13 Dec 2023, 15:53