Clinical Investigation, Graduate Certificate

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.

Boston University’s online Graduate Certificate in Clinical Investigation—designed and offered by BU’s 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.

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.

Why Choose BU’s Graduate Certificate in Clinical Investigation?

  • 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.
  • Increase skills and knowledge in clinical investigation.
  • Qualify to sit for the Association of Clinical Research Professionals (ACRP) Clinical Research Coordinator exam.

Cost

Boston University offers competitive tuition rates that meet the needs of part-time students seeking an affordable education. These rates are substantially lower than those of the traditional, full-time residential programs yet provide access to the same high-quality BU education. To learn more about current tuition rates, visit the Tuition & Fees page.

Curriculum

Students can apply a portion of the credits earned in Boston University’s Graduate Certificate in Clinical Investigation program 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.)

Requirements for the Graduate Certificate in Clinical Investigation program include an undergraduate degree from an accredited institution and a completed application form.

GMSCI640 Regulatory and Compliance Issues

This course explains the regulatory requirements for health-care products, that is, drugs, biologics, and devices. It is intended for those interested in regulatory affairs or the clinical evaluation, development, manufacture, testing and/or commercialization of these products. Provides an in-depth review of pertinent FDA regulations and guidance and links these to the scientific and logistical activities involved in taking a medical 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 Pre-Market Notification are described. 4 cr, Fall sem. [4 credits]

GMSCI660 Good Clinical Practices in Clinical Research

This course introduces students to the regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials. Practical information and exercises are designed to demonstrate GCP compliance from an industry perspective as well as from an academic perspective. Topics Include: Human protection in clinical trials, institutional review boards, selecting and qualifying investigators, consenting subjects, initiating, monitoring and closing out sites successfully and safety monitoring in clinical trials. Group discussions and exercises help students learn practical skills. 4 cr, Summer II sem. [4 credits]

GMSCI675 Designing Clinical Research Studies

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, sample size determination, and statistical analysis issues. Students will design and present a clinical research study during the course. 4 cr, Fall sem. [4 credits]

GMSCI789 Critical Evaluation of the Medical Literature

Prereq: GMS CI 675 Designing Clinical Research Studies. The goal of this course is to provide students experience in reading and evaluating current literature that may be pertinent to the origination, design, implementation and evaluation of clinical research. The course is conducted in a seminar-type format. Each week, students read and critically analyze assigned readings of recent literature which may be relevant to clinical research about human diseases. Students present their reviews of the assigned article and then lead the discussion during which the entire class participates. This format provides an opportunity to learn to critically evaluate the scientific literature and to develop presentation skills. Students will also be required to write three article critiques. Pairs of articles will be available for critique, each pair consisting of an article from the biomedical literature and a corresponding article from the newspaper or internet. Students will learn that nothing is as it always appears to be, especially in clinical research. Hess-Pino. 4 cr, Spring sem. [4 credits]

Requirements for the Graduate Certificate in Clinical Investigation program include an undergraduate degree from an accredited institution and a completed application form.

 

Getting Started

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