Clinical Research Certificate Curriculum

To earn the Certificate, students must complete:

The Certificate Program can be completed in 3-4 semesters. Once accepted into the program, individuals have a maximum of 3 calendar years to complete the requirements. The program has rolling admissions and students may start taking courses in the summer or fall semester.

A grade of B or higher in each course is required for successful completion of the Certificate program. It is the responsibility of the student to complete and submit a Program Progress Checklist after completion of each course.

The coursework for the Certificate is listed on the student's official Case Western Reserve University transcript. The Certificate itself is issued by the Clinical Research Scholars program. Course credits earned could be transferred to fulfill requirements for advanced degrees at CWRU or another institution.

Required Courses

This course is designed to familiarize students with the language and concepts of clinical investigation and statistical computing, as well as provide opportunities for problem-solving and practical application of the information derived from the lectures. The material is organized along the internal logic of the research process, beginning with mechanisms of choosing a research question and moving into the information needed to design the protocol, implement it, analyze the findings and draw and disseminate the conclusion(s).

This course provides an introduction to the principles of epidemiology covering the basic methods necessary for population and clinic-based research. Students will be introduced to epidemiologic study designs, measures of disease occurrence, measures of risk estimation, and casual inference (bias, confounding, and interaction) with application of these principles to specific fields of epidemiology. Classes will be a combination of lectures, discussion, and in-class exercises. It is intended for students who have a basic understanding of the principals of human disease and statistics.

NURS 630

This course is focused on advanced procedures for data analysis and statistical inference in health research. The course is devoted to discussion of linear models, including simple and multiple regression, logistic regression and application to study design. The role of assumptions and theory in guiding the analysis plan is emphasized through lecture, readings, and critical evaluation of published research in the student's area of interest.

CRSP 431

This course focuses on the application of statistical techniques with particular emphasis on problems in the biomedical sciences. Basic probability theory, random variables, and distribution functions. Point and interval estimation, regression, and correlation. Problems whose solution involves using packaged statistical programs.

This course introduces students to the ethical, policy and legal issues raised by research involving human subjects. Topics include (among others): regulation and monitoring of research, research in the developing world; research with special populations; stem cell and genetic research; commercialization and conflicts of interest; informed consent; study recruitment; risk-benefit assessment; the use of deception and placebos.