Master's in Clinical Research and Regulatory Affairs Program Overview, Northwestern University School of Continuing Studies

Program Overview:

Clinical Research and Regulatory Administration

Please note: This program is no longer accepting new students. Prospective students should review our new Master of Science in Regulatory Compliance program. Both the Clinical Research/Regulatory Administration and the new Regulatory Compliance degree programs are offered in partnership with the Northwestern University Clinical and Translational Sciences Institute.

Curriculum Requirements

Current students should refer to curriculum requirements for the Master of Science in Clinical Research and Regulatory Affairs in place at time of entry into the program.

Core Courses:

CLIN_RES 401-0 Research Conduct
This course examines the primary regulatory and ethical requirements for researchers, research staff members and institutions engaged in human, animal and laboratory research. It includes various legal and ethical issues, and emphasizes the responsibilities of investigators and research staff within the research enterprise.
Clinical Research track course. Core course for MCRRA, elective for MQARS students.

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CLIN_RES 402-0 Drug and Device Development

Introduces the rational for, practical aspects of and new issues in, drug and device development, as well as relevant industry and government policies and regulations. Course topics include illness targets, unmet medical need and the pharmaceutical life cycle, scientific basis for drug development (e.g., drug discovery, preclinical drug development and the patient studies including pharmacology), protocol and budget preparation, phramacoeconomics and quality of life, regulatory aspects, pharmacogenetics and information technology, biotechnology and technology transfer, and the role of academia in drug development.

Clinical Research track course. Core course for MCRRA, elective for MQARS students.

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CLIN_RES 404-0 Reg Support and Admin

This course explores federal policies and regulations related to sponsored research and responsible conduct of clinical trials as well as the design of institutional processes and systems for assuring compliance. The focus in this course will be on the roles and responsibilities of research administration and the oversight of sponsored research and clinical trials.

This class may be taken as an elective for MQARS.

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CLIN_RES 590-0 Thesis Research

This final project is meant to represent the culmination of students’ experience in the program and must demonstrate mastery of the curriculum and ability to conduct sustained independent research and analysis. The project may be applied or may be a traditional scholarly paper, in both cases a write-up following the paper’s program-specific guidelines is required. Students must submit a proposal and secure a first reader in order to register; for further details students are advised to review the student handbook and contact their academic advisor.

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LEADERS 481-0 Leadership

The purpose of this course is to identify the fundamental leadership behaviors that enable people to excel in their careers, and to help students apply these behaviors to personal and professional success. The course builds from the basic premise that leadership is learned and looks at the theory and practice of leadership at the individual and organizational level. The course will explore definitions of leadership, the importance of leadership, leadership styles, the role of vision and integrity, the importance of giving and receiving feedback, how to lead change and solve problems, effective teamwork, and communication strategies. The culmination of the class will be a personal leadership development plan formulated by each student.

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Clinical Research and Regulatory Administration

Curriculum Requirements

Core Courses:

Elective Courses:

Clinical Research and Regulatory Administration

Graduate Options

Northwestern University SCHOOL OF CONTINUING STUDIES

Clinical Research and Regulatory Administration

Curriculum Requirements

Core Courses:

Elective Courses:

Clinical Research and Regulatory Administration

Graduate Options