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.
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 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.
CRSP 401, " Introduction to Clinical Research"
(3 credit hours offered during the Summer semester)
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, "Study Design and Epidemiologic Methods"
(3 credit hours offered during the Fall semester)
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, "Advanced Statistics: Linear Models"
(3 credit hours offered during the Fall semester)
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, "Research Ethics and Regulation: Emerging Issues and Ongoing Challenges"
(2 credit hours offered during the Fall semester)
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.
All applicants for the Certificate Program should submit:
- A recent CV or resume,
- Official transcripts - For the Admissions Committee's purposes, unofficial transcripts can be used to review your application. However, if you are accepted, the School of Graduate Studies will require official transcripts.
- A Personal Statement describing the reasons for seeking clinical research training
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.
All application materials should be e-mailed to the Graduate Certificate in Clinical Research Education Administrator at email@example.com or mailed to the Education Administrator at the Population and Quantitative Health Sciences office.
Reminder: When registering for Fall/Spring, please waive any unwanted fees for Health Insurance and/or One-to-One Fitness.
Population and Quantitative Health Sciences
Case Western Reserve University
10900 Euclid Ave.
Wood Building, Room WG 74A
Cleveland, OH 44106-4945