CRRA Curriculum
Students will be required to complete four courses for the Graduate Certificate, including three core courses and a fourth elective, comprising their specialty track.
The three core courses are:
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CLIN RES 400 Essentials of Initiating Clinical Research
This course provides a comprehensive analysis of the fundamental concepts and activities in the clinical research process. Emphasis is on the regulatory and compliance standards that underscore the clinical research process as well as practical application of international and federal guidelines that govern clinical research activities.
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CLIN RES 401 Responsible Conduct of Research
This course examines the primary regulatory and ethical requirements for researchers, research staff members, and for institutions engaged in human, animal, and laboratory research. The course will emphasize the responsibilities of investigators and research staff within the research enterprise.
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MSCI 303 Drug and Device Development (a Feinberg School of Medicine course)
This course introduces the rationale for, practical aspects of, and new issues in drug and device development as well as the relevant industry and government policies and regulations.
To specialize in Clinical Trials Conduct, students will take:
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CLIN RES 403 Clinical Research Design and Methodology
This course explores the application of research design and methodology theories and concepts to the practical conduct of a clinical trial. Topics include: commonly used research designs, methods for randomization and blinding, data collection methods including electronic data capture, implications of design and methodology for clinical trial operations from study initiation to data lock.
To specialize in Regulatory Administration, students will take:
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