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Program Overview

Clinical Research

Clinical Research Advanced Certificate

Students in this certificate program are given a solid framework from which to understand clinical research. A graduate’s understanding of clinical trial design, drug development and regulatory requirements allows them to manage many facets of the clinical research endeavor, whether developing and implementing clinical research protocols or overseeing GCP, compliance and financial matters at an individual or multi-site level.



About the Clinical Research Advanced Certificate

Clinical Research Course Schedule

The Clinical Research Course Schedule page provides you with detailed information on the program's offerings.

Clinical Research Faculty

You can find a full listing of our instructors in this certificate program on the Clinical Research Faculty page.

Admission for the Clinical Research Advanced Certificate

Applicants to this certificate program must hold a graduate degree from an accredited U.S. college, university or its foreign equivalent. A competitive graduate record that indicates strong academic ability is required. Work or research experience in clinical, computing or information technology fields is highly desirable but not a requirement for admission.

This certificate program requires prerequisite coursework or knowledge. For more information, view the "additional information" section on the program overview page of your chosen certificate.

A list of admission requirements can be found on our Clinical Research Admission page.

Clinical Research Tuition

Tuition costs can vary for each of our programs. For the most up-to-date information on financial obligations, please visit our Clinical Research Tuition page.

Clinical Research Registration Information

Our Clinical Research Registration Information page outlines important dates and deadlines as well as the process for adding and dropping courses.

Additional Information

Applicants must possess a graduate degree and must demonstrate the knowledge and skills equivalent to the following course prior to applying to this program. Please see below for more information:

  • MSRC 409 Biostatistics: This course is an introduction to biostatistics. Students learn to apply statistical techniques to the processing and interpretation of data from health studies. Topics covered include probability, descriptive statistics, study design, and linear regression, among others.
  • MSRC 435 Risk and Decision Management: This course explores theories and practical applications of risk management, risk communication, decision management, and crisis management in life science industries. Topics include failure modes and effects analysis; fault-tree analysis; human factors analysis, and hazard analysis and critical control points.

Applicants who do not have this prior knowledge and who want a more comprehensive course of study should consider the Master of Science in Regulatory Compliance degree.

Find out more about Northwestern's Clinical Research Advanced Certificate

Clinical Research Required Courses

To earn a certificate, students must complete the following three courses.

  • CLIN RES 400 Essentials of Initiating Clinical Research
  • CLIN RES 401 Responsible Conduct of Research
  • CLIN RES 403 Clinical Research Design and Methodology

and one of the following courses:

  • QARS 450 Medical Device Regulations or
  • QARS 460 Drug and Biologics Regulation

In some cases, students who have completed equivalent coursework previously may be allowed to replace the required course with another course in the field.

Please note that courses completed in the certificate program cannot be transferred to the corresponding graduate degree.

Elective Courses:Course Detail
Drug and Biologics Regulations QARS 460-0

Students discuss current policies and guidelines under which pharmaceutical and biological products are developed for human use and regulated while in commerce. Topics include regulatory requirements for patented and generic pharmaceuticals, over-the-counter drugs, legal and ethical issues, and biological products. Students examine the newly implemented steps to harmonize international regulations. .

Quality Systems and Clinical Research track course. Elective for MQARS and MCRRA students.


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