The content of 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.

This course meets for 10, three hour sessions:
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: Clinical Trial Conduct, Monitoring and Record Keeping
Session 5: Components of Ethical Evaluation of Human Research and Privacy Considerations
Session 6: Recruitment and Retention, Drug Compliance and Accountability, and Study Close-Out Procedures
Session 7: Pharmacovigilance in Drug/Device Development
Session 8: Audits & Inspections: Ensuring Clinical Research Quality
Session 9: The Role of Data Management in Clinical Research
Session 10: Study Budgets and Contracts: Evaluation and Negotiation