Courses

The listing of a course description here does not guarantee a course’s being offered in a particular semester. Please refer to the published schedule of classes on the Student Link for confirmation a class is actually being taught and for specific course meeting dates and times.

• GMS CI 640: Regulatory and Compliance Issues
  This course explains the regulatory requirements for health-care products, that is, drugs, biologics, and devices. It is intended for those interested in regulatory affairs or the clinical evaluation, development, manufacture, testing and/or commercialization of these products. Provides an in-depth review of pertinent FDA regulations and guidance and links these to the scientific and logistical activities involved in taking a medical product from research to market. Content and preparation of regulatory submissions, including an Investigational New Drug Application (IND), an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologic License Application (BLA), a Pre-Market Approval Application (PMA), and a 510K Pre- Market Notification are described. 4 cr, Fall sem.
• GMS CI 660: Good Clinical Practices in Clinical Research
  This course introduces students to the regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials. Practical information and exercises are designed to demonstrate GCP compliance from an industry perspective as well as from an academic perspective. Topics Include: Human protection in clinical trials, institutional review boards, selecting and qualifying investigators, consenting subjects, initiating, monitoring and closing out sites successfully and safety monitoring in clinical trials. Group discussions and exercises help students learn practical skills. 4 cr, Fall sem.
• GMS CI 670: Biostatistics with Computing
  This course is designed for students with no prior experience with statistics who want to utilize computer software in performing statistical analysis. Topics include the collection, classification, and presentation of descriptive data; the rationale of hypothesis testing; t-tests and chi-square tests; correlation and regression analysis; sample size calculations, and analysis of contingency tables. Computer Laboratory course. 4 cr, Fall sem.
• GMS CI 671: Intermediate Statistical Analysis and Computing for Clinical Research
  This course covers analytic and computational methods for modeling and regression analysis in the biomedical sciences. Emphasis is on fitting exploratory and inferential models to data in epidemiology and clinical trials. Topics include tabular and graphical summary; the linear, logistic and Poisson regression models; the Kaplan-Meier method and Cox proportional hazards analysis; power calculation; estimation of effect size. Analyses are presented and completed using R and SAS software packages. Lecture and laboratory exercises are structured around worked examples from the recent biomedical literature. Acquired competency in statistical programming is a major focus of this course. 3 cr, Spring sem.
• GMS CI 675: Designing Clinical Research Studies
  This course covers important scientific and epidemiologic principles necessary for designing clinical research studies. Topics include bias, confounding, developing the research question, defining an appropriate study population, choosing outcome measures, clinical research ethics and regulation, sample size determination, and statistical analysis issues. Students will design and present a clinical research study during the course. 4 cr, Fall sem.
• GMS CI 680: Legal and Ethical Issues in Clinical Research
  This course examines evolving ethical and legal issues in the biosciences. Students will study the legal and ethical issues pertaining to work with human subjects both existing and historical. They will go through the historical background that set the standard for today's existing regulations and how those regulations are still in flux. Each student will do a presentation on a topic that relates to his or her own interest or existing research. Legal cases that have come from clinical research will also be covered. The course will involve class discussions, student presentations, case analyses and in-class lectures. 2 cr, Spring sem.
• GMS CI 691: Directed Studies in Clinical Research
  Directed study provides the opportunity for students to explore a special topic of interest identified by the student under the direction of a MSCR faculty member. Students may register after the MSCR faculty member has agreed to work with the student on a specific project. 2-4 cr, Fall sem.
• GMS CI 692: Directed Studies in Clinical Research
  Directed study provides the opportunity for students to explore a special topic of interest identified by the student under the direction of a MSCR faculty member. Students may register after the MSCR faculty member has agreed to work with the student on a specific project. 2-4 cr, Spring sem.
• GMS CI 789: Critical Evaluation of the Medical Literature
  Prereq: GMS CI 675 Designing Clinical Research Studies. The goal of this course is to provide students experience in reading and evaluating current literature that may be pertinent to the origination, design, implementation and evaluation of clinical research. The course is conducted in a seminar-type format. Each week, students read and critically analyze assigned readings of recent literature which may be relevant to clinical research about human diseases. Students present their reviews of the assigned article and then lead the discussion during which the entire class participates. This format provides an opportunity to learn to critically evaluate the scientific literature and to develop presentation skills. Students will also be required to write three article critiques. Pairs of articles will be available for critique, each pair consisting of an article from the biomedical literature and a corresponding article from the newspaper or internet. Students will learn that nothing is as it always appears to be, especially in clinical research. Hess-Pino. 4 cr, Spring sem.
• GMS CI 790: Seminar in Clinical Research
  The goal of this course will be to provide students experience in the reading and evaluation of recent basic science literature that may be pertinent to the origination and design of clinical research. The course will be a seminar format. It will consist of the evaluation of assigned readings of recent literature which may be relevant to the treatment of human diseases and which might be expected to lead to further animal experiments and to culminate in human trials. This format will provide an opportunity to learn to critically evaluate basic science literature and to develop oral presentation skills essential to function as a manager of clinical trials. 2 cr, Spring sem.
• GMS CI 794: Clinical Research Practicum
  The goal of the practicum experience is to provide the student hands-on exposure to clinical research. The student will work with a research mentor and will be actively involved in the development, execution, and evaluation of a clinical research project or project(s). During the practicum, it is expected that the student will be exposed to: clinical research planning, protocol preparation, interaction with Institutional Review Boards, regulatory requirements, selection of subjects/consent process, data collection, study monitoring, and data analysis. These various activities will most likely require involvement in more than one research project. Variable 2-4 cr, Fall sem
• GMS CI 795: Clinical Research Practicum
  The goal of the practicum experience is to provide the student hands-on exposure to clinical research. The student will work with a research mentor and will be actively involved in the development, execution, and evaluation of a clinical research project or project(s). During the practicum, it is expected that the student will be exposed to: clinical research planning, protocol preparation, interaction with Institutional Review Boards, regulatory requirements, selection of subjects/consent process, data collection, study monitoring, and data analysis. These various activities will most likely require involvement in more than one research project. Variable 2-4 cr, Spring sem
• GMS CI 796: Professionalism & Scientific Writing
  The objective of this elective course is to (1) provide students with knowledge of and experience in professional standards, and (2) guidance in developing a capstone proposal and writing a masters level capstone paper. Topics will include professionalism & professional standards including professional communication, formal and scientific writing skills, guidance in developing a research topic, and writing a capstone proposal and capstone paper. The primary aim of this course is to help students adjust from an informal writing style to that required for scientific communication, presentations and papers. 2 cr, Summer I
• GMS CI 802: Capstone Research
  Students in the MSCR program are required to complete a capstone project that applies the principles and methods learned in the coursework to a real- life clinical study. The goal of the capstone project is to demonstrate the student's understanding of the clinical research process from both a theoretical and a practical point of view. The capstone project is not a literature review. 2 cr, Spring.
• GMS FA 700: Professional Skills and Thesis Research Development for Forensic Anthropology
  This course is designed to provide students with knowledge and experience in professional skills, including writing skills, professional communication, requesting letter of recommendation, applying to PhD programs, interview skills, and reading and interpreting journal articles. In addition, considerable class time will be spent on developing a research topic and hypothesis, preparing a thesis proposal and in introduction to data collection, statistical analysis and the use of several instruments and tools commonly used by forensic anthropologists. 3 cr, Fall sem.
• GMS FA 703: Zooarchaeology and Comparative Vertebrate Osteology
  This course will provide students with an advanced basis for vertebrate zooarchaeological analysis including terminology, data gathering, data analysis, and practical identification skills for both whole and fragmentary vertebrate remains. These skills will be of direct use in archaeology, paleontology, and forensic anthropology. 4 cr, Fall & Spring sem.
• GMS FA 704: Bioarchaeology
  This course examines how bioarchaeologists utilize skeletal data to reconstruct patterns of human behavior from diverse geographical and temporal contexts. This course will survey topics such as age and sex estimation, paleodemography, pathology, and trauma, levels of physical activity and evidence for habitual behavior, paleodietary analyses, identity, and ethics. The goal of this seminar is to ask what bioarchaeology is, understand how t has developed historically, and recognize how it contributes to our understanding of the past. 2 cr, Spring sem.
• GMS FA 705: Forensic Anthropology Techniques
  This course will provide students with a detailed history of forensic anthropology, including pioneers in the field, bone growth and development, and an extensive knowledge of protocols, methods, and procedures used by forensic anthropologists, to include distinguishing osseous from non-osseous material, distinguishing human from non-human remains, and estimating the biological profile. Students will be provided hands on experience in casework and will prepare several forensic anthropology case. 3 cr, Fall sem.
• GMS FA 712: Human Anatomy and Osteology
  This course is designed to provide the student with an overview of basic human osteology with an emphasis on structure and function of various bones typically used by forensic anthropologists in human identification and in the investigation of traumatic and sudden deaths. At the completion of this course the student will be well versed in the anatomy, growth, landmarks and surface anatomy of all bone in the human skeleton. They will have completed hands-on experience with handling, measuring and identifying real human skeleton components. In addition, the methods of recovery and preservation of human skeletal remains will be practiced. 4 cr, Fall sem.
• GMS FA 715: Forensic Pathology
  This lecture- based course will provide the student with an overview of the role of the medical examiner as it relates to death investigations. Specific lectures will cover autopsy procedures in the investigation of gunshot wounds, sharp and blunt trauma, drowning, asphyxia, child deaths, motor vehicle accidents and time since death determination. A general knowledge of anatomy is strongly suggested. 2 cr

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