Clinical Research for Health Professionals MS

Major: Clinical Research for Health Professionals
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 MS in Clinical Research for Health Professionals program is a non-thesis curriculum designed for residents, fellows and clinicians seeking knowledge in the conduct of translational and investigator-initiated research. The degree often acts as an advanced preparation for independent investigators and other practicing researchers familiar with clinical research while developing their clinical careers.

The program is also available to other clinical health professionals such as nurses (with a minimum of a bachelor’s degree required), medical technologists, etc., to help advance their professional opportunities.

Online coursework coupled with supervised independent research activities will allow health care professionals in any academic hospital setting throughout the U.S. to receive an MS degree from Drexel University College of Medicine.

Research Project

While the MS in Clinical Research for Health Professionals program does not require a thesis, the program is consistent with a master’s-level education that challenges students to clearly express well-organized thoughts in written form. The collection, analysis and refinement of scientific information to produce a professional-level written document are crucial skills for those in the health professions. This requirement will expose students to the entire process of developing an independent research project and reporting on that research project up to and including experiencing a facsimile of the peer review and resubmission process. The research project will provide students with the opportunity to develop, test and report on research hypotheses.

It is anticipated that each student will conduct a minimum of 9 hours of research per week for 3.0 credits per semester. Research may include a broad spectrum of clinical studies such as retrospective studies, bench-top studies in conjunction or not with pharmaceutical companies, development of new clinical methodologies/techniques or development/evaluation of new medical devices. Research mentors must be established researchers with a doctoral degree. A key requirement of this mentored research is the support of a doctoral-level mentor/advisor located at the institution where the student's research will be conducted. A curriculum vitae of the proposed research mentor must be submitted with the student’s application for evaluation by the admissions committee and the program director. The appropriateness of the mentor will be evaluated by an ad hoc committee whose members come from the Graduate School of Biomedical Sciences and Professional Studies faculty. The student must submit a 7- to 10-page journal-format paper at the end of each semester, documenting their research and demonstrating that each successive semester’s work builds upon their prior work.

Additional Information

Robert Sterling, PhD
Director, Graduate Programs in Clinical Research
rcs336@drexel.edu
267.359.2310

For more information about the program and to apply, visit the Drexel University Online website.

Degree Requirements

The MS in Clinical Research for Health Professionals program requires completing a minimum of 15.0 semester credits composed of three required courses and two clinical research electives. In addition, students will register for a total of 21.0 research credits.

Research mentors must be established researchers with a doctoral degree. A curriculum vitae of the proposed research mentor must be submitted with the student’s application. The appropriateness of the mentor will be evaluated by an ad hoc committee whose members come from the Graduate School faculty.

The student must submit a 7-10 page journal-format paper at the end of each semester documenting their research and demonstrating that each successive semester’s work builds upon their prior work. Contact the program director for additional requirements.

Curriculum
Select three of the following:9.0
Epidemiology
Intro to Clinical Trials
Applications of Clinical Research Biostatistics
Scientific Writing and Medical Literature
Pharmaceutical Law
Fundamentals of Compliance
Select two of the following:6.0
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
Patient Generated Data in Clinical Research
International Regulatory Affairs
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
Research/Journal-type paper requirement (min 21.0 credits)
Each student conducts a minimum of 9 hours research/week for 3 credits per semester *21.0
Research Health Professions I
Research Health Professions II
Research Health Professions III
Research Health Professions IV
Research Health Professions V
Research Health Professions VI
Research Health Professions VII
Total Credits36.0
*

Research may include a broad spectrum of clinical studies such as: retrospective studies; bench-top studies in conjunction or not with pharmaceutical companies; development of new clinical methodologies/ techniques; or, development/evaluation of new clinical devices.

Sample Plan of Study

First Year
FallCreditsSpringCreditsSummerCredits
CRHP 501S3.0CR 500S3.0CRHP 503S3.0
CR 515S3.0CRHP 502S3.0CR 520S3.0
 6 6 6
Second Year
FallCreditsSpringCreditsSummerCredits
CRHP 504S3.0CRHP 505S3.0CRHP 506S3.0
Elective3.0Elective3.0 
 6 6 3
Third Year
FallCredits  
CRHP 507S3.0  
 3  
Total Credits 36

Note: Some terms are less than the 4.5-credit minimum required (considered half-time status) of graduate programs to be considered financial aid eligible. As a result, aid will not be disbursed to students these terms.

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.
  • Evaluate scientific and clinical research literature to effectively interpret the results of clinical research, thereby enhancing the decision-making process.
  • Demonstrate a basic understanding of fundamental principles in biostatistics and how they apply to clinical trials and medical data, choosing the appropriate study design, reviewing case report forms, report and analysis plans, and statistical sections of the clinical study report.
  • Effectively communicate the content and relevance of clinical research findings to the scientist and non-scientist community.