This course, a Thomson Reuters Cortellis Regulatory Online Learning module, examines European clinical trials legislation. The course explores the legal basis, roles of parties involved, and procedures for recruiting and protecting subjects. It describes the regulatory requirements to initiate, amend, and conclude a clinical trial. Participants also learn the procedures to request ethics committees’ opinions and competent authorities’ authorizations. The course concludes with a discussion on adverse reaction reporting during clinical trials.
- European clinical trials legislation
- European clinical trials regulations
- Reporting adverse reactions during European clinical trials
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields
Participants who complete this course should be able to:
- Understand who is involved in a clinical trial
- Determine if an activity is a clinical trial
- Identify the documents authorities require
- Describe the procedures for recruiting and protecting trial subjects
- Recognize the procedures to request an Ethics Committee's opinion and Competent Authority's authorization
- Describe amendments to clinical trials
- Understand the criteria for considering a trial to be complete
- Clarify adverse reactions reporting
The module takes an average of 1.5 hours to complete.