Clinical Research I: Understanding Concepts and Processes
This course is designed to provide a thorough overview of clinical research conduct, the drug development process, the roles of the Clinical Research Associate and Clinical Research Coordinator, and other key roles in the conduct of clinical research.
Session 1: Overview of the Clinical Research Process
Session 2: Clinical Research Personnel, Service Providers, and the Site Selection Process
Session 3: Human Subject Protections and Regulatory Oversight
Session 4: Components of Ethical Evaluation of Human Research and Privacy Considerations
Session 5: Roles and Responsibilities of Clinical Research Coordinators (CRC) and Clinical Research Associates (CRA)
Session 6: Recruitment and Retention, Drug Compliance and Accountability, and Study Close-Out Procedures