Hybrid Graduate Certificate Program

Getting Started:  Requirements for this non-Degree Graduate Certificate program include an undergraduate degree from an accredited institution and a completed online application.

Hybrid Program Design:  Students in this non-Degree program will be taking hybrid of courses on the medical campus with the masters degree students and online. The certificate program consists of four courses that explore:

GMS CI 675 Designing Clinical Research Studies – Fall Semester, On-campus

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.

Fish & Hess Pino. Fall, 4 cr.

GMS CI 660 Good Clinical Practices in Clinical Research – Fall Semester, Online

Prereq: GMS CI 675 Designing Clinical Research Studies

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.

Merhaut. Fall, 4 cr.

GMS CI 640 Regulatory and Compliance Issues – Spring Semester, Online

This 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.  Spring, 4cr.

GMS CI 790 Seminar in Clinical Investigation – Spring Semester, On-campus

**Prereq: GMS CI 675 Designing Clinical Research Studies

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.

Hess Pino & Weinberg, Spring, 2 cr.


Students have the potential to complete the program in one academic year including.  Students may also opt to take just one course per semester.

The Hybrid Graduate Certificate program in Clinical Investigation is a non-Degree program.  This is an important distinction because financial aid is not available to students in non-Degree programs. Find information about the cost per credit here.

Questions??  If you have any questions about the Hybrid Graduate Certificate program, please contact the Program Director, Stacey Hess Pino at sahess@bu.edu.