Comprehensive course analysis
Who should attend
Professionals who work in biomedical research and clinical trials and those who want to enter the field.
About the course
Conducting clinical trials is an essential part of ensuring the safety and efficacy of new pharmaceuticals and medical devices. With the large range and volume of studies required today, the field offers plenty of career opportunities for applying your skills to make a significant impact on our medical system.
In this three-course certificate program, you’ll gain a thorough understanding of the concepts that guide the design and implementation of different types of clinical trials. We’ll study the fundamental scientific, ethical, regulatory and economic principles connected with biomedical research. You’ll also explore the ethics involved in clinical trials, including the protection of human subjects and the integrity of data.
WHAT YOU'LL LEARN
- Preparation steps for implementing a well-run trial
- The essential elements of ongoing site management and the final study report
- Business dimensions of clinical trials, including principles of project management, planning, analysis, contingency and follow-up
- Practices for managing relationships among clinical trial constituencies
- Issues involved with ethical treatment of human subjects and Good Clinical Practice (GCP)
You’ll participate in group projects to develop Institutional Review Board documents, Informed Consent forms, trial management plans and budgets.
CHOOSE FROM NONCREDIT AND CREDIT OPTIONS
By completing this certificate program, you can earn up to 9 credits toward degree requirements should you later be accepted into the Master of Science in Biomedical Regulatory Affairs. To use these credits, you must enroll in the credit version of the certificate program and obtain graduate nonmatriculated status before you register for the first course. If you don’t plan to pursue a graduate degree, choose the noncredit offering. See Noncredit & Credit Options.
Eric Hayashi is president and CEO of LabConnect, a global provider of centralized laboratory testing services for the biopharmaceutical industry, and is an instructor in the UW Department of Pharmacy. He has more than 15 years of experience in the clinical trials industry, including experience at...
Education MS in Biomedical Regulatory Affairs, University of Washington David Hammond is the principal consultant of Hammond Clinical Trial Consulting and a lecturer in the Department of Pharmacy. A former clinical director, clinical study monitor and site coordinator, Hammond specializes in dev...
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