Program Overview
The Clinical Investigations MS program is a 33-credit hour master’s degree program that seeks to provide transformative education that will create a cadre of health professionals adept at designing, conducting, and reporting clinical investigations that further the human health. The program creates a unique opportunity to understand these concepts contextually in a pediatric and young adult research setting. The three educational pillars of the program are (1) basic and applied knowledge of clinical investigation design and conduct, (2) familiarity with the ethical and legal requirements for conduct of human subjects research, and (3) basic and advanced analytic methods that support clinical investigation. The duration of the program is two years. In the first year, students complete required coursework in biostatistics, epidemiology, patient-oriented research, advanced clinical and translational research methods, and scientific writing to develop competencies in foundations of clinical investigation. In the second year, students move to more specialized studies with the selection of an elective course focused on a specific area of clinical investigation, as well as training in ethical and legal issues in conducting clinical investigation. The program culminates with a thesis research project under the guidance of a thesis advisor and thesis committee. Upon completion of the Clinical Investigations MS program, graduates will be able to critically appraise existing and new clinical research identifying new interventions and strategies to improve human health. They will also have the necessary skills to develop novel clinical research following scientifically sound and ethical principles.
Student Learning Objectives
SLO 1: Apply an understanding of the fundamental concepts of biostatistics, epidemiology, clinical research, and research methods to a research project.
SLO 2: Critically evaluate scientific literature in clinical research, including the choice of methods applied to problems and the interpretation of results.
SLO 3: Design and conduct clinical research using advanced research skills, data acquisition, data management, and analysis to investigate a selected research problem.
SLO 4: Communicate clearly, accurately, and professionally to disseminate scientific concepts and research results in visual, oral, and written form to diverse audiences.
Thesis Core Curriculum
The thesis is the demonstration of the student’s mastery of both a specific content area as well as the methodology necessary to make significant contributions to medical literature. It serves as the primary locus for translation of the knowledge, tools, and skills that students acquire through the program. There are two options for the thesis in the Clinical Investigations program – the Completed Research Option and the Prospective Clinical Trial Option. Both options demonstrate the student’s exercise in research, make a substantial contribution to the field, and provide the opportunity to work closely with the student’s thesis committee.
- Completed Research Option: The Completed Research Option will represent a completed research project that demonstrates an in-depth understanding of the subject matter, development of a hypothesis, collection/analysis of data to test the hypothesis and ability to place the results within the context of previously published literature. Broadly, the final thesis will consist of an introduction outlining the importance of the specific research, a summary of existing literature, statement of a scientific hypothesis, description of methods used, including analytic methodology, results, and a discussion that places the thesis findings in the context of current knowledge with recommendations for future research and potential recommended changes in clinical management, measurement, or other interventions. Because this Thesis option requires collection and analysis of data, existing data or publicly available datasets are often used.
- Prospective Clinical Trial Option: For the Prospective Clinical Trial, the student will write and submit a protocol for consideration as thesis work. The project should demonstrate the student’s ability to apply the principles learned in the program’s curriculum to their own research project. The submitted Prospective Clinical Research Study should benefit from the advice of colleagues and experts in the field. It should include sufficient details to ensure a uniform and standardized approach to carrying out the study with good quality control. A well-thought out and well-written protocol can be judged according to three main criteria:
- Is it adequate to answer the research question(s), and achieve the study objective?
- Is it feasible?
- Does it provide enough detail that another investigator can undertake the study and arrive at comparable conclusions?
The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analyzed. It should highlight how ethical issues have been considered, and, where appropriate, how inclusion across different age groups and gender issues are being addressed. If the protocol is an interventional trial (therapeutic or non-therapeutic), it should follow protocol guidelines available in the literature to standardize the approach and outline its contents.
MS – Clinical Investigations Core Curriculum
Year 1 – Fall (9 Credits)
| CLI 8101 | Biostatistics for the Health Sciences I | 3 |
| CLI 8301 | Introduction to Epidemiology | 3 |
| CLI 8401 | 'Introduction to Patient-Oriented Research | 3 |
Year 1 – Spring (9 Credits)
| CLI 8102 | Biostatistics for the Health Sciences II | 3 |
| CLI 8302 | Advanced Clinical and Translational Research Methods | 3 |
| CLI 8402 | Scientific Writing and Communications | 3 |
Year 2 – Fall (9 Credits)
| CLI 8501 | Ethical and Legal Issues in Clinical Research | 3 |
| Elective (see below) | 3 |
| CLI 8701 | Critical Assessment of Contemporary Clinical Trials | 1 |
| CLI 8814 | Thesis Research Project | 6 |
Year 2 – Spring (6 Credits)
Electives