Master of Science and Certificate Programs in Clinical Research

With over 60 courses currently offered in clinical research and more under development, the ICRE provides didactic training for students with a wide variety of career goals relating to clinical research. Initially funded in 1999 under the K30 mechanism of the National Institutes of Health (NIH), the program leading to an MS or certificate in clinical research has become a national model for programs to educate clinical trainees at multiple levels, including junior faculty, fellows, residents, and medical students.

The core curricula of the MS and certificate programs provide basic knowledge and skills that are fundamental to all fields of clinical research. For both programs, the core courses include computer methods in clinical research, clinical research methods, biostatistics, measurement of outcomes, and ethics and regulation of clinical research. The ethics course, which can be taken either online or in the classroom, engages students in consideration and evaluation of the ethical dimensions of clinical research.

For the MS program, the core curriculum also includes a course in grant writing in which students learn how to develop a research question into an NIH-style grant proposal. The final product is a completed grant application that follows the PHS-398 application format and that has undergone significant peer and faculty review.

There are four tracks in which MS students can specialize to fulfill their remaining credit requirements.

• The Clinical Trials Research Track trains students in the design, performance, and analysis of clinical studies and relevant principles of pharmacology. Students are encouraged to develop a protocol for a study involving human subjects and then to direct the study and analyze the results.
• The Comparative Effectiveness Research (CER) Track addresses the emerging need for training in key disciplines within CER, including meta-analysis and systematic review, analysis of electronic records, and decision modeling and cost-effectiveness, as well as development of fundamental skills specific to clinical trials and statistical analysis of observational data. The track’s capstone course leads students through the development of a CER project and ties together fundamental principles of CER.
• The Health Services Research Track trains students in the effectiveness, cost, and quality of the provision of health care services. Training in research methodology, observational analysis, cost-effectiveness, and health care economics provides students in this track with the skills necessary to evaluate the impact of society’s health care services and associated costs.
• The Translational Research Track focuses on T1 translation and is appropriate for students interested in how discoveries and findings from basic research can be turned into studies of human subjects. Discoveries in basic sciences, especially the sequencing of the human genome and microbiologic advances, offer extensive opportunities for applications related to new and improved strategies for the prevention, diagnosis, and treatment of diseases.

Students in the certificate program complete a total of 15 credits. Elective courses for both the MS and certificate programs are listed as follows.

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