Summary

In this one day course we will cover and discuss the – often very complex – legal rules and principles for contracts in clinical trials as well as the requirements as a result of these contracts. We will focus on substantial sections in contracts, including responsibility, ownership of inventions and data, rights of publication and insurance.

We will discuss how you as an investigator, project manager/nurse, clinical coordinator, monitor, clinical trial manager or similar, prepare, negotiate and indemnify a contract in the best way possible, as well as how you make sure the consequent requirements are met.

Keywords

General information about contracts
Guidelines and laws that regulate contracts
Types of contracts
Rights and duties for sponsor and investigator
Ownership of data
Insurance

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Course leader & lecturers

Hans-Christian Lund
Course leader
General Counsel
GUBRA ApS
Mikkel Sørensen
Course leader
Associate Director, Legal Counsel
Genmab A/S

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Is this course for you?

This course is for anyone who works with contracts in clinical trials, e.g. in a hospital as an investigator, project manager/project nurse, clinical coordinator, monitor or clinical trial manager.

What you will learn

Understand what a clinical contract between a hospital and a commercial sponsor is and the implications of the contract.
The substantial requirements, considerations and interests behind clinical contracts
The latest knowledge in the field of clinical contracts
Practical and useful information and good advice applicable in your work forward
Which insurances are necessary, and why?

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 to clinical contracts
An employee who can assure an optimal and fast process when it comes to entering clinical contracts
An employee who understands which requirements should be met when conducting the contracts

Course calendar

9 Oct 2025 9:00-16:00

Day 1

Background and history of this course

Review and discussion of relevant legal concepts/issues in clinical contracts
Cases

Network

Insurances

Workshop

Practical information

Registration

Registration deadline
2 Oct 2025

Atrium
Lersø Parkallé 101
2100 København Ø

Attend on location (7,100 DKK)

Attend online (0 DKK)

Register

9 Oct

Sometimes things change. This is the expected programme.

Course information

Literature

Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

Please familiarize 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 asked to submit issues that you experience in everyday life and wish to be discussed at the course.

Prerequisites

Experience with contractual relations in clinical trials is an advantage, but not a requirement.

Examination

There is no examination for this course.

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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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Contracts and Insurance in Clinical Trials