Clinical Research Organization and Management MS
Major: Clinical Research Organization and Management
Degree Awarded: Master of Science (MS)
Calendar Type: Semester
Minimum Required Credits: 36.0
Classification of Instructional Programs (CIP) code: 51.0000
Standard Occupational Classification (SOC) code: 11-9199
About the Program
The Master of Science in Clinical Research Organization and Management is an online program designed for individuals already trained in the area of clinical sciences, as well as for others who desire a focused education in the proper conduct of clinical research.
The Master of Science in Clinical Research Organization and Management program offers students a rigorous graduate education taught by leaders from the pharmaceutical, biotechnology and medical device industries, as well as from academic research centers. The program provides online courses that include scientific rationale related to the design and analysis of clinical trials, epidemiology and biostatistics, ethics-based reasoning for the conduct of research, clinical trial management and monitoring processes, and federal regulatory rules and policies, all of which are essential to the development of a broadly educated and well-prepared professional in clinical research and new therapeutic product investigation.
The program is designed so that graduates will be able to:
- Successfully apply the framework and philosophies of research to the management of clinical trials, employing quality principles of current good clinical practice to produce valid and useful data
- Ensure that sound ethical principles and values are always recognized and upheld in research involving a human population
- Use current statistical knowledge and methods in the design, implementation, conduct and assessment of clinical trial programs
- Describe the scientific and clinical research literature to effectively interpret the results of clinical research, thereby enhancing the decision-making process
Students work with advisors to customize their course plans to meet their career goals.
Program Delivery Options
All clinical research courses are offered solely online. Visit Drexel University Online for details.
Additional Information
Robert Sterling, PhD
Director, Graduate Programs in Clinical Research
rcs336@drexel.edu
267.359.2310
For more information about the program, visit the Drexel University Online Master of Science in Clinical Research Organization and Management web page.
For information about applying to the program, visit the Drexel University Online Admissions Criteria web page.
Degree Requirements
The Master of Science in Clinical Research Organization and Management program consists of 12 courses (36.0 credits). Any courses offered by the Clinical Research Organization and Management program (subject code "CR") may be applied to fulfill the requirements of this major. No master's thesis is required.
The program is organized into five areas of study devoted to clinical research and related administrative and regulatory issues. Students may take courses within their preferred area of study, a cross-section of courses within other areas of study, or any other Clinical Research (CR) courses being offered.
| Program Requirements | 36.0 | |
| New Product Research and Development | ||
| Intro to Clinical Trials | ||
| Scientific Writing and Medical Literature | ||
| Designing the Clinical Trial | ||
| Innovative Product Development | ||
| Introduction to Clinical Pharmacology | ||
| Regulatory, Scientific and Social Issues Affecting Biotech Research | ||
| Compliance and Safety Surveillance | ||
| Compliance & Monitoring Issues | ||
| Principles and Practice of Pharmacovigilance | ||
| Fundamentals of Compliance | ||
| Quality Assurance Audits | ||
| Ethics and Law | ||
| Ethical Issues in Research | ||
| The History of Misconduct in Biomedical Research | ||
| Pharmaceutical Law | ||
| Contemporary Issues in Human Research Protection | ||
| Healthcare Inequities in Biomedical Research | ||
| Regulatory | ||
| Emerging Trends in Medical Device Regulation | ||
| Medical Device Combination Product Regulation | ||
| World Wide Regulatory Submissions | ||
| Current Issues in Review Boards | ||
| Current Federal Regulatory Issues in Biomedical Research | ||
| International Regulatory Affairs | ||
| Patient Generated Data in Clinical Research | ||
| Biostatistics and Data Management | ||
| Epidemiology | ||
| Applications of Clinical Research Biostatistics | ||
| Clinical Data Management | ||
| Health Information Technology in Biomedical R&D | ||
| Applications of Clinical Research Biostatistics II | ||
| Clinical Research Management | ||
| Sponsored Projects Finance | ||
| Fundamentals of Academic Research Administration | ||
| Clinical Project Management | ||
| Patient Recruitment and Informed consent | ||
| Leadership Skills | ||
| Risk Management in Clinical Research | ||
| New Therapeutic Product Business and Strategic Planning | ||
| Business Processes and Contemporary Concerns in Pharmaceutical R & D | ||
| Clinical Trial Budgeting | ||
| Clinical Outsourcing | ||
| Informatics in Pharm Res & Development | ||
| Health Policy and Economics | ||
| Strategic Planning | ||
| Total Credits | 36.0 | |
Sample Plan of Study
| First Year | |||
|---|---|---|---|
| Fall | Credits | Spring | Credits |
| Program Requirements | 6.0 | Program Requirements | 6.0 |
| 6 | 6 | ||
| Second Year | |||
| Fall | Credits | Spring | Credits |
| Program Requirements | 6.0 | Program Requirements | 6.0 |
| 6 | 6 | ||
| Third Year | |||
| Fall | Credits | Spring | Credits |
| Program Requirements | 6.0 | Program Requirements | 6.0 |
| 6 | 6 | ||
| Total Credits 36 | |||
Program Level Outcomes
- Successfully apply the framework and philosophies of research to the management of clinical trials, employing quality principles of current good clinical practice to produce valid and useful data.
- Demonstrate sound ethical principles and values as they are recognized and upheld in research involving a human population.
- Use current statistical knowledge and methods in the design, implementation, conduct, and assessment of clinical trial management.
- Explain the elements of clinical study design, implementation, and data integrity and quality assurance.
- Summarize the legislative and regulatory framework that supports the development and registration of new medicines, devices, and biologics.
- Describe and evaluate the design conduct and documentation of clinical trials as required for GCP guidelines.