Clinical Trials Design and Management
Issued by
UCSC Silicon Valley Extension
Individuals in this program have mastered the practical aspects of running and managing a clinical trial, such as trial design and phases, good clinical practices, the drug discovery and development process, and quality control and assurance. They are familiar with the numerous legal and ethical issues of clinical research, including FDA regulations and ICH guidelines, compliance, and bioethics.
- Type Learning
- Level Advanced
- Time Months
- Cost Paid
Skills
Earning Criteria
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Completed two prerequisites: Human Physiology in Health and Disease and Medical / Clinical Terminology; five core courses: Principles of Drug Discovery and Development; Clinical Statistics for Non-Statisticians; Clinical Trials Site Monitoring; Good Clinical Practices; Science of Clinical Trials Design; either Medical Devices: Regulatory Strategies and Marketing Pathways or Regulation of Medical Devices and Diagnostics; minimum two electives. Earned 19 units. Met all certificate requirements.
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Many Clinical Trials Design and Management courses qualify for continuing education credit for professional organizations and credentials, including the Association of Clinical Research Professional (ACRP), the California Board of Registered Nursing (BRN); and the the Regulatory Affairs Certification (RAC) exam.