Clinical investigation 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 Boston University Online Graduate Certificate in Clinical Investigation—designed and offered by the Boston University School of Medicine—is an opportunity for clinical researchers, health professionals, and those interested in clinical research to gain an in-depth understanding of the scientific fundamentals of human research. Courses in the curriculum provide an in-depth look at a number of the key elements in clinical investigation, including: trial design and conduct, clinical research regulations, good clinical practices of research, and the critical evaluation of clinical research in the medical literature.
The certificate program consists of four online courses that explore:
GMS CI 675 OL Designing Clinical Research Studies – Fall Semester
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. [4 cr]
GMS CI 660 OL Good Clinical Practices – Fall Semester
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]
GMS CI 640 OL Regulatory and Compliance Issues – Spring Semester
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.]
GMS CI 789 OL Critical Evaluation of the Medical Literature – Spring Semester
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]
Upon completion, students will have developed essential skills and understanding involving the elements and importance of good clinical research design, implementation and practices. Clinical and health professionals of all varieties—including physicians, research nurses study coordinators, managers in clinical research and site management, and professionals in the pharmaceutical, biotechnology, and medical device industries, as well as CRO and SMO organizations—will benefit from this opportunity to:
- Earn a graduate certificate from Boston University’s School of Medicine, a leading research institution
- Complete a valuable professional credential in just four full semesters of study
- Potentially apply a portion of the credits earned toward a Master of Science in Clinical Investigation (MSCI)
(Note: The MSCI program is comprised of campus-based courses and is not available in an online format.)
- Increase skills and knowledge in clinical investigation
- Qualify to sit for the Association of Clinical Research Professionals (ACRP) Clinical Research Coordinator exam
Online Certificate Tuition and Fees:
- Cost/credit hour = $925/credit hour = $3700/course
- Technology fee = $ 60/credit = $ 240/course
- Registration fee = $ 40
- Total cost per course = $3980/course
Important Dates – for information regarding registration and start dates for courses, please search here.
Requirements for the program include an undergraduate degree from an accredited institution and a completed application form.
Questions?? If you have any questions about the Online Graduate Certificate program, please contact the Program Director, Stacey Hess Pino at 617-638-5211 or firstname.lastname@example.org.