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Medicine

Certificate Program

Graduate Certificate in Clinical Research

The Graduate Certificate in Clinical Research program combines knowledge from biostatistics, epidemiology and study design with training in ethical, legal and regulatory issues in patient-oriented research. Upon completion of the Certificate Program, individuals will achieve basic competency in the following domains:

  • Formulation of Clinical Research Questions
  • Literature Critique
  • Study Design
  • Analytic Methods
  • Research Ethics

Who should apply?

The Certificate program provides foundational training in clinical research methods to those individuals who are seeking an alternative to the Master of Science Program in Clinical Research. It is geared towards clinicians (physicians, nurses, dentists, pharmacists, etc.) and other health-science professionals who are interested in conducting clinical research or collaborating with other clinician-scientists who conduct clinical research. This program is also beneficial to health-science students, basic-science researchers and other health science professionals who would like to enhance their skills in patient-oriented research.

Program Structure

To earn the Certificate, students must complete:

  • 4 courses totaling 11 credit hours
  • The online CITI Basic course in the Protection of Human Research Subjects, or your institution's equivalent

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.

Grade of B or higher in each graded 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 (PDF)' after completion of each course to the Center for Clinical Investigation.

The coursework for the Certificate is listed on the official CWRU transcript. The Certificate itself is issued by the Center for Clinical Investigation. Course credits earned could be transferred to fulfill requirements for advanced degrees at CWRU or another institution.

Required Courses

CRSP 401 (3 credit hours) - Introduction to Clinical Research

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).

CRSP 402 (3 credit hours) - Study Design and Epidemiologic Methods

This course covers the methods used in the conduct of epidemiologic and health services research. The course begins with how to quantify disease frequency and compare it across populations, often as a way to generate hypotheses about what factors may cause a given condition. The course introduces methodological issues that need to be considered in the design and conduct of epidemiologic studies, including classification of disease and exposure status, types and consequences of misclassification, effect modification and related concepts. Additional sessions focus on the control of confounding and on the three main types of study designs: randomized trials, cohort studies and case-control studies. Topics include: Measures of disease frequency, measures of effect, classification and misclassification, cross-sectional studies, case-control studies, cohort studies, randomized controlled trials, confounding, bias and effect modification.

NURS 630 (3 credit hours) - Advanced Statistics: Linear Models

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 603 (2 credit hours) - Research Ethics and Regulation: Emerging Issues and Ongoing Challenges

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.

Reminder: When registering for Fall/Spring, please waive any unwanted fees for Health Insurance and/or One-to-One Fitness.

Admissions

  • All applicants for the Certificate Program should submit a Personal Statement describing the reasons for seeking clinical research training and a recent CV or resume.
  • Individuals who are not already graduate degree-seeking students at CWRU are admitted as non-degree-seeking candidates through CWRU School of Graduate Studies. An Application for Admission is required (for complete step-by-step application instructions view Non-Degree Application Guidelines (PDF)). Individuals who are not faculty, staff, or employees of CWRU must also submit a transcript or copy of their diploma, documenting completion of a baccalaureate degree.
  • All application materials should be e-mailed to the Center for Clinical Investigation Education Manager at ccieducation@case.edu or mailed to:

Contact Information

Angela Bowling, MA
Education Administrator
Center for Clinical Investigation
Case Western Reserve University
Iris S. & Bert L. Wolstein Building
2103 Cornell Road, Room 6133
Cleveland, OH 44106-7291

angela.bowling@case.edu
Telephone: 216.368.2601
Fax: 216.368.0207