The Boston University Online Graduate Certificate in Clinical Investigation consists of four required online courses.
Covers important epidemiologic principles necessary for designing clinical research studies. Topics include bias, confounding, developing the research question, defining an appropriate study population, choosing outcome measures, clinical research ethics and regulation, and statistical analysis issues. [4 cr]
Introduces regulatory responsibilities of sponsors, monitors, and investigators 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. [4cr]
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.]
Provides students experience in reading and critically evaluating current research published in the medical literature pertinent to the origination, design, implementation and evaluation of clinical research. [4cr]
Visit the Boston University Online Course Schedule to view all current and upcoming courses.