MCR Curriculum

Clinical Research Management Specialization

The Clinical Research Management Specialization focuses on the management of systems and processes in the conduct of clinical trials to prepare graduates to lead complex national and international clinical research operations. Graduates of this track will have attained the skills to work as Clinical Research Coordinators (CRCs) or Clinical Research Associates (CRAs) representing the study sponsor or investigation site and to advance their careers as clinical research administrators.

Clinical Research Management specialization courses

In addition to the core coursework, students in the Clinical Research Management Specialization will complete the following courses:

Required specialization courses:

• MCR 7404 Project Management for Healthcare and Clinical Research
• MCR 7481 Data Management and Informatics in Clinical Research
• MCR 7402 Economic Evaluation of Healthcare Interventions (cost-effectiveness studies)
• Pharmacy 7570 Pharmaceutical Safety & Risk Management
• MCR 7599 Culminating Project in Clinical Research

Regulatory Affairs Specialization

Regulatory Affairs is an expanding area in medical product development in the U.S. and globally. Regulatory Affairs professionals represent a diverse array of roles, with the commonality of being a key point of contact between companies and regulatory bodies such as the U.S. FDA. Areas of focus are vast and may include quality assurance, clinical trial reporting (e.g., regulatory writing), medical product development and promotional review.

Coursework in the Regulatory Affairs Specialization emphasizes the assurance of the safe and effective medical product development and use throughout the product life cycle – from conception to commercialization. Topics in the specialization cover regulatory strategy during medical product development, regulatory oversight and documentation and report generation. Graduates from this track may work in many settings, including academic institutions, government, pharmaceutical companies, institutional review boards (IRBs) and clinical research organizations (CROs).

Regulatory Affairs specialization courses

In addition to the core coursework, students in the Regulatory Affairs Specialization will complete the following courses:

Required specialization courses:

• Pharmacy 7460 Regulatory Strategy, Writing and Leadership
• Pharmacy 7570 Pharmaceutical Safety & Risk Management
• Pharmacy 7572 Federal Regulations of Medical Products
• Pharmacy 7580 Principles of Safety Pharmacology
• MCR 7599 Culminating Project in Clinical Research

Full-Time Plan of Study:

Year 1

Autumn

• Product Development and Regulation (3 credits)
• Research Design and Methods (3 credits)
• Data Analysis (3 credits)
• Safety and Risk Management (3 credits)

Spring

• Responsible Conduct of Research (3 credits)
• Research Study and Site Management (3 credits)
• Specialty Coursework (3 credits)
• Specialty Coursework (3 credits)

Summer

• Pharmacology (3 credits)
• Quality Management (3 credits)
• Specialty Coursework (3 credits)
• Final Project (3 credits)

Part-Time Plan of Study:

Year 1

Autumn

• Product Development and Regulation (3 credits)
• Research Design and Methods (3 credits)

Spring

• Responsible Conduct of Research (3 credits)
• Research Study and Site Management (3 credits)

Summer

• Pharmacology (3 credits)
• Quality Management (3 credits)

Year 2

Autumn

• Data Analysis (3 credits)
• Safety and Risk Management (3 credits)

Spring

• Specialty Coursework (3 credits)
• Specialty Coursework (3 credits)

Summer

• Specialty Coursework (3 credits)
• Final Project (3 credits)

The MCR program was the second graduate clinical research program in the United States accredited by CAAHEP. All MCR students attain applied competencies as defined by the Joint Task Force for Clinical Trial Competency.

If you have questions about this program, please reach us at OnlineEnrollment@osu.edu.