Online | Drafting and negotiating clinical trial agreements
24 May 2022–25 May 2022, 9:30 am–5:00 pm
UCL Laws Events
24 & 25 May 2022
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.
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.
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.
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.
- Course Schedule
DAY ONE - 14:00 - 17:30
14:00 Introduction to the course;
14:05 Issues that typically arise; regulatory framework (UK and EU) and how this affects CTAs.
15:00 (approx.) 5 mins comfort break
15:05 Other Legal and Drafting issues, including review of NHS CTA
16:00 (approx.) 5 mins comfort break
16:30 Group drafting/negotiation exercises; answers
17:00 – 17:15 (approx.) day one ends
DAY TWO - 10:00 - 13:00
10:00 Agreements to develop medical devices – overview of regulatory issues
10.45 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
- About the Tutor
The course has been designed, and will be run, by Mark Anderson. Mark has nearly 30 years’ experience of drafting, negotiating and advising on agreements for life-science companies and universities, including CTAs. He is the general editor of Drafting Agreements in the Biotechnology and Pharmaceutical Industries (OUP loose-leaf since 2008). He has many years’ experience of giving courses on CTAs. For several years, he has been recommended as a national expert on life science transactions by Chambers Directory, and on patent licensing by IAM Patent 1000. His credentials are
Solicitor: He is a practising solicitor, who is recommended in Chambers Directory for both life science transactions and IP. He is 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 is a Certified Licensing Professional (a qualification established by the Licensing Executives Society (US and Canada)).
Author: He is the author or co-author of 7 practitioner texts on IP and contract drafting subjects, published by OUP, LexisNexis, Bloomsbury and Law Society Publishing. They include:
Technology Transfer (4th edn, Bloomsbury, 2020). ‘All practitioners who deal with technology transfer arrangements in England and Wales should own a copy of this work.’ (Journal of E-commerce, Technology and Communications)
Drafting and Negotiating Commercial Contracts (4th edn, Bloomsbury, 2015). ‘It is one of the best, if not the best, texts on the principles of commercial drafting… The material is extremely well written and accessible.’ (Student Law Journal).
Execution of Documents (3rd edn, Law Society, 2015). ‘This is, for a highly technical law book, a riveting read. Keep it on your shelves and you’ll be confident that you will have the answer to most issues about how to make a legal document work.’ (New Law Journal)
A-Z Guide to Boilerplate and Commercial Clauses (4th edn, Bloomsbury, 2017). ‘An extremely useful reference work, the book will be of great benefit to in-house counsel drafting commercial contracts’ (the In-House Lawyer). ‘[The book] is very useful and I hope that it will reach a wider audience.’ (His Honour Humphrey Lloyd QC, The International Construction Law Review).
Drafter: He and his colleagues have drafted hundreds of precedents for commercial contracts, which have been published by OUP, LexisNexis and others.
Trainer: He has run CPD courses on contract drafting subjects for the last 20 years, and is the course director of a 5-day course, Intellectual Property Transactions: Law and Practice, which is run by the Institute of Brands and Innovation Law at University College London
Standard fee = £600
Standard Group Ticket / IBIL Sponsor / UCL alumni = £510
Other discounts may be available - please email firstname.lastname@example.org
- Course delivery
This course will delivered via Zoom. You will need to download Zoom to your computer or use the online version of Zoom. You will be sent a unique link on the Friday before your course.
Course materials will be delivered to you via a dedicated sharepoint site for the course.
- Cancellation and Refunds
All cancellations and refund requests must be made in writing 10 full working days (Monday to Friday) prior to the start of the event to the Laws events team (or to the contact person for the event).
If the above notification period is not given, or in the event of non-attendance, then the following cancellation fee applies:
- £25 for a half-day workshop
- £50 for one day workshop
UCL Laws reserves the right to make changes to the programme, location and/or speakers without prior notice. Such alterations are occasionally necessary due to circumstances beyond our control.
During the event, please ensure that your attendance is noted each day to avoid being charged the cancellation fee - this will normally be by signing an attendance sheet at registration.
Refunds will be made to the payment method used for the original payment, ie if you paid via card you will receive your refund to your card, less any cancellations fees (if applicable).
In the event of non-attendance due to illness, a doctor’s certificate must be provided, otherwise the full cancellation fee will be charged. Individuals who withdraw after the start of an course will still be liable for the cancellation fee as outlined above.
Cancellation and non-attendance for paid events
An individual who has registered for an event who doesn't provide the required 10 working days notice and who fails to attend will NOT receive a refund. This is due to administrative, speaker and catering costs incurred by the department (and your place could have been allocated to another individual).
Attendees are welcome to send a substitute without incurring a charge, provided UCL Laws is notified in writing (please email email@example.com or the event contact person) three full working days prior to the event.
UCL Laws reserves the right to cancel or re-schedule an event due to unforeseen circumstances. In the unlikely event of cancellations, UCL Laws will refund the full amount of the registration fee (if applicable). However, personal expenses incurred by the attendee are non-refundable by UCL Laws.
If you have any queries about this course please email Lisa Penfold in the UCL Faculty of Laws at firstname.lastname@example.org