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“Live”/Medical Campus Graduate Certificate Program
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 Live/Medical Campus 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. Students in this program will be taking courses on the medical campus with the masters degree students. 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 “Live” certificate program consists of four courses that explore:
GMS CI 675 Designing Clinical Research Studies
Prereq: Consent of instructor.
This course 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, sample size determination, and statistical analysis issues. Students will design and present a clinical research study during the course.
GMS CI 640 Regulatory and Compliance Issues
Prereq: Premedical course requirements and Consent of Instructor.
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. Provided is an in-depth review of the pertinent FDA regulations and guidelines and links these to the scientific and logistical activities involved in taking a product from research to market.
Content and preparation of regulatory submissions, including an Investigational 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 PreMarket Notification are described. International requirements for health care products are also reviewed.
Aulwes. Fall, 4cr.
GMS CI 790 Seminar in Clinical Investigation
Prereq: GMS CI 675 Designing Clinical Research Studies and Consent of instructor.
The goal of this course is to provide students experience in reading and evaluating current l literature that may be pertinent to the origination, design, implementation and evaluation of clinical research. The course is conducted in a seminar format.
Each week, students read and critically analyze assigned readings of recent literature which may be relevant to clinical research about human diseases. Teams of students then read the discussion in seminar and the entire class participates. This format provides an opportunity to learn to critically evaluate the scientific literature and to develop oral presentation skills.
Fish, Hess Pino, Spring, 2 cr.
GMS CI 660 Good Clinical Practices in Clinical Research
Prereq: consent of instructor.
Introduces regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials. Practical information and exercises are designed on GCP compliance fro m 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.
Malikova. Summer, 4 cr.
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
- Apply a portion of the credits earned toward a Master of Arts in Clinical Investigation (MACI)
- Increase skills and knowledge in clinical investigation
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 Live Graduate Certificate program, please contact the Program Director, Stacey Hess Pino at 617-638-5211 or firstname.lastname@example.org.