Overview
Key facts
University College London (UCL)'s Drafting and Negotiating Clinical Trial Agreements 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.
Programme Structure
Courses 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
Key information
Duration
- Part-time
- 2 days
Start dates & application deadlines
Language
Delivered
Disciplines
Health Sciences View 323 other Short Courses in Health Sciences in United KingdomAcademic requirements
We are not aware of any specific GRE, GMAT or GPA grading score requirements for this programme.
English requirements
We are not aware of any English requirements for this programme.
Other requirements
General requirements
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.
Tuition Fee
-
International
510 GBP/fullTuition FeeBased on the tuition of 510 GBP for the full programme during 2 days. -
National
510 GBP/fullTuition FeeBased on the tuition of 510 GBP for the full programme during 2 days.
Cost: £510 to £600