Programme de Certificat d'Études Supérieures en Recherche Clinique en Ligne

Clinical research is the fastest growing discipline in the burgeoning medical device and pharmaceutical industries. Keeping pace with the ever-increasing body of knowledge and new regulatory procedures generated by advances in clinical research is critical to career success.

The objective of the Nondegree program is to provide an in-depth understanding of the scientific fundamentals of human research.

The Curriculum provides an in-depth understanding of key, fundamental elements of clinical research, including:

• Clinical trial design and conduct
• Clinical research regulations
• Good clinical practices of research
• Critical evaluation of the medical, research literature

Who can benefit from this program?

– Clinical and health professionals of all varieties, including:

• physicians, dentists
• research nurses
• study coordinators,
• managers in clinical research and site management,
• professionals in the pharmaceutical, biotechnology, and medical device industries, as well as CRO and SMO organizations

Benefits of this program:

• Earn a graduate certificate from Boston University’s School of Medicine, a leading research institution
• Qualify to sit for the Association of Clinical Research Professionals (ACRP) Clinical Research Coordinator exam AND waive the two-year work requirement
• Apply a portion of the credits earned toward a Master of Science in Clinical Research (MSCR) (Note: The MSCR program is comprised of campus-based courses and is not fully available in an online format.)
• Complete a valuable professional credential in just 2-4 full semesters of study while increasing your skills and knowledge in clinical research.

The certificate program consists of four online courses that explore:

GMS CI 675 OL Designing Clinical Research Studies – Fall Semester, 4 credits

This course covers important scientific and 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.

GMS CI 660 OL Good Clinical Practices – Fall Semester, 4 credits

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.

GMS CI 640 OL Regulatory and Compliance Issues – Spring Semester, 4 credits

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 an 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), an 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 healthcare products are also reviewed.

GMS CI 789 OL Critical Evaluation of the Medical Literature – Spring Semester, 4 credits

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.

CI 675 OL is a prerequisite for this course. [4cr]

Benefits of learning online

Interactivity

Boston University Online programs are filled with activities, animations, and simulations to ensure that students get the most out of their experience. Students participate actively in each course through a variety of means, including online discussions, quizzes, and assignments.

Flexibility

Versatility is a key feature of Boston University Online courses and programs. Online course materials are available twenty-four hours a day, seven days a week, from any location. Which means that students can learn where and when it works best—for them. Each student determines which hours are best for studying, attending lectures, and completing assignments. Though students must complete course requirements within an established time frame, the actual hours spent meeting those requirements are mostly at the convenience of each individual.

The Graduate Medical Sciences (GMS) at Boston University School of Medicine (BUSM) is a recognized leader in research and graduate education in biomedical sciences. Our more than 900 students can choose from 33 fields of study, with interdisciplinary programs available in many areas. Students may pursue Ph.D. or M.D./Ph.D. degrees in 15 different Departments and Programs. Masters degrees may be earned in many of these fields as well as in Medical Sciences, Mental Health Counseling and Behavioral Medicine, Clinical Research and other scientific and health services oriented disciplines. Certificates are also available in several areas of study.

GMS is located in the historic South End of Boston in the hub of a modern urban academic health center, Boston University Medical Center (BUMC), which includes Boston University School of Medicine , Boston University School of Public Health and the Boston University Henry M. Goldman School of Dental Medicine . Also on campus is Boston Medical Center , one of Boston’s leading teaching hospitals and the primary teaching affiliate of BUSM. Together, these institutions boast a world-class faculty with many established collaborations between clinical and basic science investigators. This provides a unique opportunity for students to participate in translational and cross-disciplinary research using state-of-the-art core facilities (e.g. imaging, flow cytometry, proteomics and gene expression analysis). Visit our Student Life page to learn more about life on campus and in Boston.

History

Boston University Medical School has a rich history dating back to 1848 when it began as the New England Female Medical College. Notably, it was the first institution in the world to offer medical education to women and also to graduate the first black woman physician. In 1873, the medical college merged with Boston University, becoming the first coeducational medical school in the nation.

BUSM is now home to nearly 1600 graduate and medical students who have chosen to pursue advanced degrees in an institution committed to excellence in training the scientists, physicians and biomedical educators of tomorrow guided by the institutional learning objectives, BU CARES .