Introduction to Clinical Research: Clinical Trial Phases and Design

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.