Lesson Code: CTM-1102. Clinical trials are conducted to distinguish a drug’s effect from other influences in order to determine the safety and efficacy of that drug for a specific indication. This Lesson provides an overview of the structure and key activities of a clinical trial. It describes the trial process from the planning stages through to implementation and completion. The Lesson reviews key concepts and elements of clinical trial design and introduces basic trial design principles.
After taking this e-Lesson, you will be able to:
- Understand and explain at an overview level the stages of a clinical trial
- Describe the roles and responsibilities of the clinical trial team
- Explain the key steps involved in planning, designing and conducting clinical trials
- List the types of documentation in a clinical trial and describe the case reporting form and trial protocol
- Explain data management in a clinical trial