This course is designed to provide you with an insight in 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.
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 of a model contract and/or model provisions.
Furthermore, the understanding and negotiating of specific study contract provisions are reviewed and discussed.
Course time09h00 - 17h00
Who should attend
Project Managers (PMs) and upper management
This course might be too basic for attendees with a robust legal background (it is not for lawyer).
- Good Contract Practice
- Anglo-American contracts and Continental European contracts
- Liability, Indemnification and Insurances
- Intellectual Property and Confidentiality
- Standards of Performance
- 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
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