Graduate Certificate in
Clinical Investigation
Boston University School of Medicine - Division
of Graduate Medical Sciences
Courses
The Boston University Online Graduate Certificate in Clinical Investigation consists of four required online courses.
Visit the Boston University Online Course Schedule to view all current and upcoming courses.
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GMS AN 712 Biostatistics
This course will provide you with a working understanding of experimental design and statistical analyses that are appropriate for various types of relatively small sample based experiments such as those used in the biological, medical, pharmacological, psychological, and social sciences in general. 4 cr, 2nd sem. [ 4 cr.]
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GMS CI 640 Regulatory Compliance Issues (GMS CI 640 and GMS CI 640 OL)
Course explains the regulatory requirements for healthcare products, that is, drugs, biologics, diagnostics, and devices. Intended for those interested in regulatory affairs or in the clinical evaluation, development, manufacture, testing and/or commercialization of these products. Provides in-depth review of pertinent FDA regulations and guidelines and relationship to scientific and logistical activities involved in taking a product from research to market. Content and preparation of regulatory submissions, including an Investigation New Drug Application (IND), and Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologic License Application (BLA), a Pre-Market Approval Application (PMA), and a 510K Pre-Market Notification are described. International requirements for health care products are also reviewed. [ 4 cr.]
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GMS CI 660 Good Clinical Practices in Clinical Research
Prereq: consent of instructor. In-troduces regulatory responsibilities of sponsors, monitors, and investi-gators conducting clinical trials. Practical information and exercises are designed on GCP compliance from an industrial perspective. Topics include: selecting qualified investigators; obtaining ethical approval for patients, and initiating sites successfully. Group discussions and guest speakers help students learn practical skills. [ 4 cr.]
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GMS CI 675 Design and Conduct of Clinical Trians (GMS CI 675 and GMS CI 675 OL)
Covers the history and current methodologies used in the design and conduct of clinical triala. Topics include compliance, cost measures, and effectiveness. [ 4 cr.]
