Program Overview:

Clinical Research

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.

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.

Required Courses

To earn a certificate, students must complete the following four 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:

  • CLIN RES 402 - Drug and Device Development or
  • QARS 450 - Medical Device Regulations or
  • QARS 460 - Drug and Biologics Regulation or

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.

Courses:

  • QARS 460-0 Drug and Biologics Regulations
  • CLIN_RES 400-0 Clinical Research Essentials
  • CLIN_RES 401-0 Research Conduct
  • CLIN_RES 403-0 Clinical Research Design
  • QARS 450-0 Medical Device Regulations