Summary
In this one-day course, you'll learn about the often highly complex legal concepts involved in contracts in clinical trials.
The course focuses on the key sections of these contracts, including liability, data ownership, publication rights, and examines the differing interests between a sponsor and a hospital.
We will also discuss how you, as an investigator, project manager/research nurse, clinical coordinator, monitor, clinical trial manager or similar professional, can approach and negotiate a clinical trial contract.
Keywords
- General information about contracts
- Guidelines and laws that regulate contracts
- Types of contracts
- Rights and duties for sponsor and investigator
- Ownership of data
- Publication
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Course leader & lecturers
- Hans-Christian LundCourse leaderGeneral Counsel
Gubra A/S - Mikkel SørensenCourse leaderAssociate Director, Legal Counsel
Genmab A/S
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Is this course for you?
This course is designed for professionals working with clinical trials and associated contracts and is highly relevant for those based in hospital settings, including investigators, project managers/research nurses, clinical coordinators, monitors, lawyers and clinical trial managers. It provides practical insights and tools that can be applied directly in your day-to-day work.
What you will learn
- Insight into general legal concepts within contracts and how they apply in the context of clinical trial agreement
- Understand what a clinical contract between a hospital and a commercial sponsor is and the implications of it
- The substantial requirements, considerations and interests behind clinical contracts
- The latest knowledge in the field of clinical contracts
- Practical useful information and advice applicable in your daily work
What your company will get
- An employee who understands the important process of collaboration between clinical sites and sponsors
- An employee who will bring valuable input and insights to the table in connection with clinical contracts
- An employee who can assure an optimal and fast process when entering into clinical contracts
- An employee who understands which requirements should be met when negotiating and finalising the contracts within clinical trials
Course calendar
Day 1
- Background and history of this course
- Review and discussion of relevant legal concepts/issues in clinical contracts
- Cases
- Network
- Workshop
Registration
Registration deadline1 Oct 2026
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarise yourself with the mandatory readings before starting the course.
The course focuses on helping you solve practical challenges in your everyday tasks. Therefore, before the start of the course, you will be required to submit issues that you experience in everyday life and wish to be discussed at the course.
Prerequisites
Experience with contracts in clinical trials is an advantage, but not a requirement.
Examination
There is no examination for this course.
Course leaders
Gubra A/S
Genmab A/S
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Want to know more or need help?
Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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