Legal Basics for Clinical Study Contracts
About this course
Reasons to attend
This Legal Basics for Clinical Study Contracts 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
Course schedule
We provide this course in two distinct formats: Classroom OR OnlineClassroom: 1-Day face-to-face: 09:00 - 17:00 | Online: 2 webinar sessions |
Course Description
This Legal Basics for Clinical Study Contracts 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.govProgramme 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.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)
Anonymous
Anonymous
Deirdre O'Brien
Tallaght University Hospital
Assel Murat
National Center for Health Development
Mariana Moreira
VUB