Legal Basics for Clinical Study Contracts
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| 06/11/2023 | Legal Basics for Clinical Study Contracts | Brussels | EUR 1000.00 | Book |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
This course is designed to provide you with an insight into the management of study contracts, the basics of the legal requirements regarding clinical studies that need to be captured in a study contract, and the structure and main provisions of study contracts. You will receive hints and tricks on understanding and negotiating specific study contract provisions.
What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
Classroom: 1-Day face-to-face: 09:00 - 17:00 | Online: 2 webinar sessions |
Course Description
This 1-day course provides essential information about the management and negotiation of study contracts. The basics of the legal requirements for studies in Europe that need to be captured in study contracts, the structure of a study contract as well as the practical handling of the contractual documents are presented based on a model contract and/or model provisions. Furthermore, the understanding and negotiating of specific study contract provisions are reviewed and discussed. Here's a link for more info about the Histories, Policies and Laws from Clinicaltrials.gov
Programme highlight
- Good Contract Practice
- Anglo-American contracts and Continental European contracts
- Liability, Indemnification and Insurances
- Intellectual Property and Confidentiality
- Publications
- Standards of Performance
Learning objectives
- Basic understanding of the legal requirements that should be covered in a study contract
- Application of “Good Contract Practice” on study contracts
- Understanding and negotiating of complex and specific study contract provisions
Who should attend
Project Managers (PMs) and upper management Procurement officers This course might be too basic for attendees with a robust legal background (it is not for lawyer).
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (0)
- Clinical Studies Operations (GCPs or ISO 14155 (0)
- Study and Site Management (2)
- Data Management and Informatics (0)
- Leadership and Professionalism (1)
- Communication (1)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained
Trainers
The trainer is clearly an expert in the field, and is a clear and calm presenter, who gave good explanations and examples. It was not an easy topic, but the course was well and thoroughly prepared. In the future I will read contracts with more knowledge and in a different light.
Great course held by exceptional specialists in the field. The content was mad understandable and the balance between the theory and workshops was just right.
Karim Chellaoui
Materialise
Having different types of stakeholders around the table was an enriching experience - I received an overview of the relevant parts constituting a clinical research agreement. It helped to build confidence in the CTA we will be working on.
Saskia Broekman
Hovon
Rita Molenaar
The booklet that was handed to use with the training slides are a good tool and review source - the interaction and experiences from other participants.
Anonymous
Anonymous