Master of Science in Clinical Research Courses
MSCR required curriculum
MSCR 761 Introduction to Clinical and Translational Research [CTR] (2 credits)
This course introduces the fundamentals of human subjects research in CTR. It begins with the building blocks of hypothesis development, population and study sample selection, defining study measures, and power and sample size calculations. The course then conducts a broad survey of observational and experimental study designs, including systematic review and meta-analysis. Throughout the semester the team science aspect of CTR is emphasized with students working together in groups in organized class and on-line activities.
MSCR 530 Analytic Methods for Clinical and Translational Research I (3 credits)
Epidemiologic methods are covered for studying the determinants and distributions of health outcomes in human population with an emphasis on hypothesis formulation; causal inference; experimental vs. observational research; measurement; detection of interaction; study design (e.g. cohort, cross-sectional, case-control); evaluation of the sources and direction of bias; control of confounding factors; random error (frequentist vs. Bayesian approach); and epidemiology in clinical settings (screening, diagnosis, and therapy).
MSCR 500 Introduction to Biostatistics (3 credits)
Provides an introduction to applied biostatistical data analysis. Topics covered include numerical and graphical descriptive statistics, one-and two-sample inferences for means and proportions, simple and multiple linear and logistic regression, and one- and two-way analysis of variance. After completing the course, students are expected to be able to independently and rigorously implement the covered methods and to interpret results for standard analyses.
MSCR 533 Data Management (2 credits)
Provides an introduction to concepts in data management and analysis using SAS statistical software on personal computers. Topics covered include importing data, in-stream data entry, variable manipulation, subsetting, concatenating and merging data sets. Data management principles for maintaining data quality are presented. The course is coordinated with MSCR 500, and SAS procedures used to implement the statistical methods from that course are also presented. After completing the course, students are expected to be able to independently manage small or moderately large data sets and to analyze the data using SAS.
MSCR 591 Community Engagement and Health Disparities in Clinical and Translational Research (1 credit)
Led by Emory University (EU) and Morehouse School of Medicine (MSM) faculty, this course is an introduction to the concepts, methods, and issues involved in community engaged research with communities. Special emphasis is given to social and behavioral science concepts and methods; principles and historical roots of community engagement; clinical and translational research partnerships, multidisciplinary research collaborations; ethical issues; and practical considerations in planning, implementing, evaluating, and disseminating community-engaged research. Case studies and course projects are shaped to accommodate students with diverse interests in health disparities, communities, and/or translational research. Students are assumed to have a general research and clinical background, but the course emphasizes research theory and concepts with a goal to encourage thoughtful and effective community-based research collaborations.
MSCR 595 Health Services Research (1 credit)
This course provides students with an understanding of the nature, methods, scope, magnitude, and impact of Health Services Research (HSR). Students gain a better appreciation for the importance and relevance of HSR in improving healthcare delivery as well as key tools employed in HSR and areas of funding. Classes are designed to demonstrate the broad scope and multi-disciplinary nature of HSR by providing lectures from experts on a wide variety of topics that also provide practical examples of HSR.
MSCR 534 and MSCR 534 (Lab) - Analytic Methods for Clinical and Translational Research II (3 credits)
Continuation from analytic epidemiology and data management courses in the first semester. Aids students in developing analytic skills necessary to model data collected from experimental and observational studies in order to assess the role of multiple risk factors in association with health outcomes. The focus is on linear regression, logistic regression, and survival analysis. The goal is to provide a foundation for understanding the multivariable nature of human health events and develop the critical reasoning to apply these skills towards an overall analytic approach.
MSCR 536 Analysis of Clinical Research Data (2 credits)
Provides hands-on experience in the analysis, interpretation, and presentation of clinical research data. Topics covered include methods for data collection, data management and data cleaning in SAS, overview of descriptive and multivariable analysis techniques, strategies for addressing missing data, and the writing and communication of science in the format of a peer-reviewed manuscript and an oral, in-class scientific presentation. The goal is for the student to reach a level of skill with data collection, data analysis, and data presentation to begin and successfully complete the analysis and presentation of thesis research data.
MSCR 509 Overview of High Dimensional Data Analysis (2 credits)
To introduce modern bioinformatics techniques to researchers and practitioners, including statistical and computational techniques for the analysis of high dimensional data. This course will emphasize the statistical and computational concepts behind these techniques, and illustrate their applications to the medical field. Often, these illustrations will take the form of reading and discussing results from recently published medical studies dealing with high dimensional data.
MSCR 520 Clinical Trial Design (2 credits)
MSCR 520 is an introduction to fundamental and quantitative issues in clinical research and clinical trial design co-taught by a biostatistician and a clinician. Traditional and non-traditional study designs including aspects of experimental design and analysis are covered in this course. Study design, sample size, randomization, repeated measures, interim analyses, missing data and interpretation of results are emphasized. Major topics in clinical trial design including good clinical practice and challenges and successes associated with clinical trials conducted at Emory are highlighted. Students participate in class sessions with oral presentations on the advantages and disadvantages of a selected innovative clinical trial design.
MSCR 592 Clinical Research Colloquium (1 credit)
Seminar-style course that covers a wide array of practical issues in CTR including: research administration and grants management; federal funding process; IRB and HIPAA; Conflict of Interests; Legal Aspects of Translational Research; Drug Discovery; Industry interactions (drug discovery and device development); Multidisciplinary research and Team Science; Mentor and mentee training; Translational Research Informatics, Health Services and Implementation Science Research.
MSCR 593 Ethical, Legal, and Social Issues of Responsible Clinical and Translational Research (1 credit)
This course prepares students to engage in theoretically and practically based discourse and decision making in ethical issues involved in clinical and biomedical research. The course will survey a variety of ethical issues occurring in basic and applied research settings and analyze approaches that seek to prevent or resolve them. Classes will primarily consist of the faculty and students leading discussions around various articles and case studies.
MSCR 594A&B Scientific and Grant Writing (2 credits)
The goal of this class is to help you become an excellent grant writer. Some students will work on grant proposals that will be submitted to funding agencies such as the NIH while others will write a ‘practice’ grant proposal that will be of the quality of an actual competitive grant proposal. The final product for this course is a grant proposal with all the required components outlined in the table below. You will receive feedback from the instructors on all your writing throughout the course. Certificate students may submit a pure cell and/or animal-based research grant proposal, but it must include details on the translational significance of the proposed work for potential human investigation. Certificate students may also submit a proposal that includes human subject research as part of or as the entire proposal, if they choose. MSCR students MUST submit a grant proposal that includes human subject research as part of or as the entire proposal. The grant may thus also include cell/animal research components. NIH defines translational/human subject research as studies involving data derived from identifiable human subjects, and thus can include databases, blood/tissue biobank material, work with cells isolated from identifiable humans, including primary culture, etc. The grant proposal cannot be based solely on work with human cell lines or animal model/primate research.
MSCR 598 Big Data to Knowledge (BD2K) in CTR Research (1 credit)
The course will teach and expose students to fundamental data workflow principles universal to application of big data science in CTR. The elements of this workflow comprise the Big Data Pipeline and concern the generation, acquisition, processing, analysis, and presentation of Big Data. The application of this workflow will be taught through three extended case studies in the fields of clinical health informatics (electronic medical records), public health informatics, and “omics” with three corresponding projects to engage students in the acquisition and organization of data.
MSCR 596 Advanced Data Management in R – ELECTIVE (2 credits)
This course is an elective that KL2 scholars, TL1 trainees or other MSCR or CPTR students. This elective introduces the “R” statistical programming language with a focus on data management tasks (importing, cleaning, reshaping, transforming, and exploring data) and reproducible statistical analysis. R packages for the creation of publication-quality figures and tables are introduced, further extending the student’s capabilities to create a complete and reproducible data-processing pipeline from raw data to presentation and publication. Statistics available in “R” along with packages for logistic and time-to-event modeling are also covered.
MSCR 599R - Investigative Mentored Research Thesis (5 credits)
All MSCR participants conduct a mentored thesis project in clinical or translational research (PhD graduate students will complete a PhD thesis on a CTR related topic in lieu of the master's thesis). The thesis requires developing a hypothesis-driven research proposal to investigate a clinical/translational research question, followed by data collection, analysis of data and presentation of results (both oral and written in a format suitable for publication in the medical literature). It should incorporate appropriate procedures and skills learned in formal course work. The research thesis may focus on a therapeutic clinical trial, interventional study, observational study, an epidemiologic or molecular epidemiologic study, a clinical evaluation program (health services, outcomes, etc.), or a translational research project. Students provide an oral presentation to the Georgia CTSA Research Education Executive Committee and submit a written thesis which must be approved by the MSCR program and Dean of the Emory Laney Graduate School. MSCR students are strongly encouraged to present their thesis data at a national meeting and publish their thesis data in a peer-reviewed journal. The data may also impact and serve as the foundation for a career development grant submitted to NIH (e.g. F32, K-series) or a foundation.
Non-credit requirements include an Institutional Review Board (IRB) rotation, a monthly CTR Journal club as well as training in leadership, team science, mentorship and entrepreneurship.
Mentored Clinical Internship for PhD Graduate Students and PhD-level Scientists in the MSCR Program: Predoctoral PhD graduate students typically have little or no practical experience interacting with patients who have diseases relevant to their research interests. To address this gap, the program will arrange for individualized mentored clinical experiences for trainees who will work with one or more clinical research faculty who successfully perform funded multidisciplinary CTR at the Georgia CTSA institutions (e.g. Emory, MSM or UGA clinical research sites). This rotation will be tailored to be relevant to the trainee's research interests and can occur in the inpatient and/or the outpatient setting. The clinical mentor-investigator will provide practical training to the trainee, including how to interview and recruit patients for CTR studies, and bedside teaching of pathophysiologic concepts. The internship will occur over a course of the first year of PhD/MSCR training. The experience will include a minimum of 20 half-days of clinical exposure at clinical research sites. The variety of experiences that can be arranged include attending outpatient clinics with one or more physician-investigators; observing diagnostic or therapeutic procedures (e.g. imaging, surgery, physical examinations) in tertiary- and community-based research sites; state-of-the art clinical analytical technologies; shadowing multidisciplinary inpatient and/or outpatient teams caring for patients with disorders or diseases of interest; working with clinical research coordinators in conduct of ongoing clinical trials; and mentored examination of histologic sections of human tissues in the setting of a clinical pathology department. The goal is to provide the non-physician trainee with a new set of experiences relevant to both their understanding of disease and their research interests and to illuminate the impact of high-quality CTR in clinical outcomes of individuals with disease.