Understanding EU Clinical Investigation Agreements
Course Description:
This course provides a fundamental understanding of the legal terms and responsibilities needed to ensure optimal clinical investigation agreements within the EU. It outlines the basic principles and mechanisms that make up a clinical investigation agreement, as well as what should be regulated or included in clinical investigation agreements.
Watch the Course Trailer:
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Comprehend the basic principles and mechanisms of an EU clinical investigation agreement
- Explain why clinical investigation agreements are necessary
- Identify what should be regulated within a clinical investigation agreement
- Distinguish what should or should not be included in a clinical investigation agreement
Who Should Enroll:
Clinical project managers and directors, sales and marketing managers involved in the agreement process, clinical investigators, and hospital administration staff involved in contract reviews are all welcome to participate in this course.
Prerequisite Knowledge/Requirements:
The following courses are required:
- Introduction to Good Clinical Practice (ID 42)
- ISO 14155: In-Depth Review (series; IDs 61–67)
- Clinical Project Management Complete 10 Course Suite (series; IDs 97–106)