This course, a Thomson Reuters Cortellis Regulatory Online Learning module, covers the basics of clinical investigations. It defines the phrase “clinical trial” and explores the history of clinical trials. The course examines the responsibilities of parties involved in clinical trials and the importance of clinical studies in overall pharmaceutical development. Different types of clinical studies and designs are outlined. Also covered are the selection of study objectives, subjects, endpoints, methods to minimize bias, control group, and sample size. The course looks at the regulatory requirements and internationally accepted practices for the conduct of clinical trials. The course concludes with a review of clinical trial registries and databases.
- Basics of clinical trials
- Clinical study design methods
- Clinical trial regulations and internationally accepted practices
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields
Participants who complete this course should be able to:
- Recognize historical milestones of clinical trials
- Clarify the roles and responsibilities of parties involved in clinical trials
- Identify clinical studies in the drug development process
- Understand the different types of clinical trial design
- Provide detailed information on the selection of study objectives, endpoints, subjects recruitment and sample size
- Outline the conduct of clinical trials
The course takes an average of one hour to complete.