Clinical Research (MS)

Required Core Courses (20 credits)

Students are required to complete 20 credits of core coursework.  This includes all of the following courses:

• CRE - 556 Clinical Research Design Credit(s): 4
• CRE - 561 Introduction to Epidemiology Credit(s): 2
• GCC - 546 Principles of Biostatistics I Credit(s): 2
• GCC - 548 Bioinformatics Credit(s): 1
• GCC - 551 Ethics and IRB Credit(s): 2
• PHR - 556 Tools for Research Credit(s): 1
• CRE - 900 Independent Study Credit(s): 1-9 (Note: CRE-900 is a variable credit course.  Clinical Research students must take a minimum of 4 credits of CRE-900 to earn their degree.)    

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  Students also select an additional 5 credits of coursework from the following courses. Students select courses based on their specific career goals:

• GCC - 552 Intro to Regulatory Process Credit(s): 2
• CRE - 562 Advanced Epidemiology Credit(s): 2
• CRE - 559 Readings in Special Populations Credit(s): 1
• GCC - 547 Principles of Biostatistics II Credit(s): 2
• GCC - 549 Bioinformatics II Credit(s): 1
• GCC - 593 Introduction to Grantsmanship Credit(s): 1

Additional Required Coursework (12 credits)

• CRE - 597 Thesis Research Credit(s): 1-9

Example Curricula

Example Curricula

The program curricula is personalized and will depend on the prior training and interests of each student.

The following are examples of curricula choices:

Track 1. Clinically-trained students that are interested in becoming physician-researchers might choose to enroll in:

1. Tools for Research
2. Biostatistics I (and II)
3. Bioinformatics I (and II)
4. Ethics and IRB
5. Clinical Trials I and II
6. Introduction to Grantsmanship
7. Epidemiology
8. Readings in Special Populations
9. Healthcare Outcomes

Track 2. A student interested in Analytics focusing on Quality, Safety and Value might choose:

1. Tools for Research
2. Biostatistics I (and II)
3. Bioinformatics I (and II)
4. Clinical Trials I and II
5. Ethics and IRB
6. Introduction to Grantsmanship
7. Epidemiology
8. Healthcare Outcomes

Track 3. Non-clinically trained students interested in becoming a clinical research professional might choose:

1. Tools for Research
2. Biostatistics I (and II)
3. Bioinformatics I (and II)
4. Clinical Trials I and II
5. Ethics and IRB
6. Intro to Regulatory Process
7. Epidemiology
8. Readings in Special Populations
9. Practicum in Clinical Research

Practicum

Students can choose to participate in an optional Practicum or Independent Study in Clinical Research in addition to their capstone/thesis research project.  The goal of the practicum is to provide the student hands-on exposure to clinical research.  The student will work with a mentor and will be actively involved in the development, execution, and evaluation of a clinical research project or projects.  During the internship/practicum, the student will be exposed to a variety of research activities that may include: clinical research planning, protocol preparation, interaction with Institutional Review Boards, regulatory requirements, selection of subjects/patients for the clinical trial, study monitoring, and data analysis.  The practicum may be completed with a mentor who is actively conducting clinical research studies within a clinical research or hospital setting.  It may also be performed under the direction of a clinical research professional within a drug, device or biotechnology company, a clinical research organization (CRO), or site management organization (SMO) actively involved in clinical trials.  A minimum of 8 weeks of participation is required for completion of the practicum course.

Capstone/Thesis Research

Students in the MSCR program are required to complete a capstone/thesis that provides a culminating experience and applies the principles and methods learned in the coursework to a real-life research project.  The goal of the capstone/thesis is to demonstrate the student’s understanding of the clinical research process from both a theoretical and a practical point of view. Students can conduct their thesis research in a wide variety of settings including, but not limited to, academia, biotechnology, pharmaceutical or device companies. 

Students generally identify their mentor and advisory committee, and develop their research proposal while they are completing their coursework. The research project must involve the analysis and interpretation of data. Students are encouraged but are not required to conduct primary data collection (e.g. preexisting patient health information). Students must meet with their advisory committee at least once every six months, and the committee is responsible for reviewing and approving the capstone/thesis. Once approved, the student defends the thesis in a 45-minute public defense that includes their committee, capstone mentor, MSCR students and faculty members and any other interested parties.  The public defense is immediately followed by a closed-door defense with their committee only.  The purpose of the oral presentation is to demonstrate the student’s ability to (1) clearly describe the research topic, methods and results; (2) demonstrate their understanding of study design and analytic principles and methods; and (3) place their research into a clinical context.

All students will be required to submit the capstone/thesis to ProQuest to be eligible for graduation. All students are encouraged to formulate their original research into a scientific journal article and submit the manuscript as a publication in a peer-reviewed journal.

Course of Study

The MSCR Program can be completed either part-time or full-time depending on the goals of the student.  Courses will take place either online, asynchronously, or in the late afternoons or early evenings.  The Program is designed so that a full-time student may complete their coursework in one academic year, including summer. Practicum and capstone components of the program should begin as soon as mentors have been identified, and the time frame for finishing requirements will be determined on a student-by-student basis by the research mentor, committee, and Program Directors.   Part-time students must register for at least four but not more than 11 credits each academic term until all course requirements are fulfilled.