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Gain a solid foundation in clinical research by reviewing the drug development process, the principles of good clinical practice, clinical trial phases and design, the principal players in clinical research and regulatory oversight of medical devices.
Course Outline
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Course Objectives
- Understand the overall drug development process
- Identify the stages of drug development
- Describe and decipher medical terms
- Describe the principles of good clinical practice, as well as regulations and guidelines applicable to clinical trials
- List and describe the clinical phases of drug development
- Discuss post-marketing drug trials
- Discuss the roles of the FDA and ICH
- Describe the role and responsibilities of clinical trial investigators, clinical trial sponsors and contract research organizations (CROs)
- Understand the constitution, roles and responsibilities of institutional review boards (IRBs) and independent ethics committees (IECs) with regard to human subject research
- Understand the relationships between sponsors and vendors such as CROs
- Understand clinical trial design considerations
- Discuss the role of evidence-based medicine in trial designs
- List the components of investigational new drug (IND) applications, and describe the application development and submission processes
- Describe regulatory guidelines for medical devices and medical device clinical trials
How You Learn
- Multimedia lectures
- Reading assignments
- Research discussion forums and assignments
- Written assignments
- Review quizzes
- Midterm and final exams
Is This Course Right for Me?
This class is geared for those who are new to clinical trials and to those entering the clinical research field.