MCR Curriculum

The MCR is designed with a set of core courses covering the application of clinical research principles and a set of specialization courses providing in depth learning in an area of focus. The program requires 36 credits of coursework that may be completed on either a full- or part-time schedule in 12-24 months (12-month option available for students entering in autumn only). The program concludes with a culminating project. Students who are novices to clinical research report rapid entry to the clinical research enterprise during or post-graduation.

Core curriculum

All MCR students will complete the following core courses to build a solid foundation in the theory and conduct of clinical research.

Core courses
  • Nursing 7781 Responsible Conduct of Research
  • Nursing 7770 Fundamentals of Medical Product Development and Regulation
  • Nursing 7782 Clinical Research Design and Methods
  • Nursing 7405 Clinical Research Study and Site Management
  • Nursing 7482 Principles of Quality Management for Medical Product Development
  • Pharmacy 7784 Data Analysis and Interpretation in Clinical and Preclinical Research
  • Pharmacy 5010* Fundamentals of Pharmacology

* Pharmacology may be substituted for pharmacology, if students have had prior pharmacology coursework at the graduate or upper undergraduate level.

You may select from one of two specializations in the MCR program: 

  • Clinical Research Management
  • Regulatory Affairs

 

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:

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

 

Sample Plan of Study

The MCR is designed with a set of core courses covering the application of clinical research principles and a set of specialization courses providing in depth learning in an area of focus. The program requires 36 credits of coursework that may be completed on either a full-time or part-time schedule. Below is a sample part-time 24-month plan of study.

Year 1
Autumn

Nursing/Pharmacy 7770 Medical Product Devpt. and Regulation (3 credit hours)
Fundamentals of Medical Product Development and Regulation Function of clinical research in medical product development and the regulatory process of new medical products. Laws and regulations concerning the development, testing, commercialization, and total product life cycle for medical products. Regulations governing the conduct of clinical research, including study sponsors, investigators, and Institutional Review Boards.
Prerequisites: none

Nursing/Pharmacy 7782 Clinical Research Design and Methods (3 credit hours)
Study of research design and methods used in clinical research. Measurement issues, bias and confounding, statistical considerations, evaluation of published clinical research designs, and protocol and proposal development.
Prerequisites: none

Spring

Nursing 7781 Responsible Conduct of Research (3 credit hours)
Concepts and policies for the responsible conduct of research (RCOR) and Institutional Review Boards, including leadership and team science.
Prerequisites: none

Nursing/Pharmacy 7405 Clinical Research Study and Site Management (3 credit hours)
Fundamental principles of clinical research operations from study site selection to study closure from the perspective of sponsors and clinical research sites including an introduction to database design, management, quality assurance and reporting for site and sponsor operations.
Prerequisite: Nursing/Pharmacy 7770

Summer

Pharmacy 5010 Fundamentals of Pharmacology (3 credit hours)
This course presents an overview of basic principles underlying drug action including an investigation of current treatments for a variety of common diseases. In addition, this course will implement activities that emphasize the ethical aspects an implications of a variety of drug therapies.
Prerequisites: none

Nursing 7482 Principles of Quality Management for Medical Product Development (3 credit hours)
Concepts and application of total quality management for federal regulation of medical product development including drugs and medical devices.
Prerequisite: Nursing/Pharmacy 7405

Year 2
Autumn

Pharmacy 7784 Data Analysis and Interpretation in Clinical and Preclinical Research (3 credit hours)
Introduction to the principles of biostatistical methods used in biomedical research. Analysis of clinical and preclinical research data and interpretation of statistical results in biomedical studies.
Prerequisite: none

Pharmacy 7570 Pharmaceutical Safety & Risk Management (3 credit hours)
Comprehensive investigation of pharmacovigilance initiatives and pharmaceutical safety regulation. Pharmaceutical risk management in premarket testing and development, recognition of safety signals, post-approval experience, drug production, risk mitigation, and administration of pharmaceuticals.
Prerequisite: Nursing/Pharmacy 7770

Spring

Nursing 7481 Data Management and Informatics in Clinical Research (3 credit hours)
Introduction to fundamental principles of clinical research data management and informatics to include the acquisition and management of data during clinical research studies, including source data, data entry, data quality assurance, reporting, and security.
Prerequisite: Nursing/Pharmacy 7782

Nursing 7402/Pharmacy 5402 Economic Evaluation of Healthcare Interventions / Introduction to Pharmacoeconomics (3 credit hours)
Introduction to economic evaluation of (pharmaceutical) healthcare interventions and services, including evaluating costs and health outcomes, using results to inform resource allocation, interpretation and evaluation of economic evaluations in the literature, and decision analysis in healthcare.
Prerequisite: none

Summer

Nursing 7404 Project Management for Healthcare and Clinical Research (3 credit hours)
Principles of project management and strategic planning in healthcare, clinical research, and regulatory settings.
Prerequisite: Nursing/Pharmacy 7782

Nursing/Pharmacy 7599 Culminating Project in Clinical Research (3 credit hours)
The culminating project is an independent scholarly project that allows students to apply skills and competencies acquired across the master’s program in clinical research. During the course, students will also complete their professional ePortfolio.
Prerequisite: Admission to the master’s program in clinical research or permission of the instructor

 

Core Competencies

On completion of the core coursework in the MCR program, students will have attained competencies as defined by the Consortium of Academic Programs in Clinical Research and the Joint Task Force for Clinical Trial Competency:

  • Scientific Concepts and Research Design
  • Ethical and Participant Safety Considerations
  • Medical Product Development and Regulation
  • Clinical Trials Operations (Good Clinical Practices)
  • Study and Site Management
  • Data Management and Informatics
  • Leadership and Professionalism
  • Communication and Teamwork

Additional skills will be gained in the student’s chosen area of specialization through courses taught by faculty and practicing clinical research professionals with expertise in these areas.

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