Regulatory Compliance, MS Clinical Research Specialization

Students specializing in clinical research are given a solid framework from which to understand clinical research. A graduate’s understanding of clinical study 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.


Core Courses (6 units)

Course Title
MSRC 401-DLQuality Systems
MSRC 405-DLApplied Research and Writing
MSHA 409-DLStatistical Analysis
MSRC 435-DLRisk and Decision Management
MSRC 481-DLLeadership in the Regulatory Environment
MSRC 498-DLCapstone
or MSRC 590-0 Thesis Research

Specialization Courses (4 units)

Course Title
CLIN_RES 400-DLEssentials of Initiating Clinical Research
CLIN_RES 401-DLResponsible Conduct of Research
CLIN_RES 403-DLClinical Research Design & Methodology
QARS 450-DLMedical Device Regulations
or QARS 460-DL Drug and Biologics Regulations

Cross Specialization Elective (1 unit)

Course Title
Choose one
Healthcare Regulatory Environment
Healthcare Programs and Enforcement
Healthcare Billing Models & Systems
IT Systems Compliance
Practical Quality Management
Applied Quality & Regulatory Practices
Quality Assurance Project Management
Medical Device Regulations 1
Drug and Biologics Regulations

Whichever of the two courses (450 or 460) that was not taken as part of the specialization

About the Final Project

Students pursue their capstone experience independently or as part of a team. As their final course, students take either the individual research project in an independent study format or the classroom final course in which students integrate the knowledge they have gained in the core curriculum in work assigned by the instructor. In both cases, students are guided by faculty in exploring the body of knowledge on regulatory compliance while contributing research of practical value to the field. The capstone independent project and capstone class project count as one unit of credit.

Course Title
Choose one
Thesis Research