Courses

• GMS CI 640: Regulatory and Compliance Issues
  Prereq: Premedical course requirements and consent of instructor. Course explains the regulatory requirements for health care products, that is, drugs, biologics, and devices. 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. Gloff. 4 cr, Fall sem.
• GMS CI 660: Good Clinical Practices in Clinical Research
  Prereq: consent of instructor. 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. Oommen. 4 cr, Summer sem.
• GMS CI 670: Biostatistics with Computer
  Prereq: consent of instructor. 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. Laboratory course. Travison. 4 cr, Fall sem.
• GMS CI 675: Designing Clinical Research Studies
  Prereq: consent of instructor. 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. Fish, McNair. 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 (such as Moore v. Regents of CA) will also be covered. Class discussions, student presentations, case analysis and in-class lectures will be supplemented with online activities as well as the composition of a legal brief. Yashon. 2 cr, Summer sem.
• GMS CI 691: Directed Studies in Clinical Investigation
  Directed study provides the opportunity for students to explore a special topic of interest identified by the student under the direction of a MACI faculty member. Students may register after the MACI faculty member has agreed to work with the student on a specific project. 2-4cr, all sem.
• GMS CI 692: Directed Studies in Clinical Investigation
  Directed study provides the opportunity for students to explore a special topic of interest identified by the student under the direction of a MACI faculty member. Students may register after the MACI faculty member has agreed to work with the student on a specific project. 2-4cr, all sem.
• GMS CI 789: GMS CI 789 OL 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.
• GMS CI 790: Seminar in Clinical Investigation
  Prereq: CI 675. 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. Fish, Hess Pino. 2 cr, Spring sem.
• GMS CI 791: Clin Inv Prac
  
• GMS CI 792: Clin Inv Prac
  
• GMS CM 761: Critical Thinking in Cell and Molecular Biology
  The purpose of this course is to train students in the art of reasoning and critical thinking in the pursuit of answers to biological questions. The goal of 761 is to examine a field of science and evaluate/understand how it developed at critical branch points. The goal of 762 is to use the framework of the scientific literature to develop Critical Thinking Skills to generate novel hypotheses in any area of Cell and Molecular Biology. Critical Thinking skills will be used to examine research findings and theories to uncover inconsistencies, bias, or faulty logic. The student will be expected to build on their careful evaluation and analysis of the papers to create a new hypothesis. Brecher, Layne. 2 cr, Fall and Spring sem.
• GMS CM 762: Critical Thinking in Cell and Molecular Biology
  The purpose of this course is to train students in the art of reasoning and critical thinking in the pursuit of answers to biological questions. The goal of 761 is to examine a field of science and evaluate/understand how it developed at critical branch points. The goal of 762 is to use the framework of the scientific literature to develop Critical Thinking Skills to generate novel hypotheses in any area of Cell and Molecular Biology. Critical Thinking skills will be used to examine research findings and theories to uncover inconsistencies, bias, or faulty logic. The student will be expected to build on their careful evaluation and analysis of the papers to create a new hypothesis. Brecher, Layne. 2 cr, Fall and Spring sem.
• GMS CM 764: Cell and Molecular Biology Professional Presentation Skills
  The course is designed for first year graduate students. The goal of this course is to teach students how to present their research in written and oral form. Students will give multiple short oral presentations and be critiqued. They will also give one longer presentation. Students will learn to give presentations with and without slides. Students will also begin to acquire written skills in preparation for the Proposal writing course in the second year. The course will meet weekly. Trinkaus-Randall. 2 cr. Fall sem.
• GMS CM 766: Mini-Courses in Cell and Molecular Biology
  Prereq: consent of instructor. Two six-week courses are presented. I. Imaging of Biological Systems: The goal is to discuss and demonstrate principles of fluorescence microscopy. There is both a classroom and hands on component. If time permits a small independent project may be conducted by students to enhance familiarity with instrumentation. II. Proposal Writing: The goal is for students to learn how to write the components of a proposal. Sessions include evaluation of writing. The culminating project is a proposal on their work. In the past a member of the NRSA study section has been invited to answer questions. Trinkaus-Randall. 2 cr, Spring sem.
• GMS CM 951: Res Cell & Mol
  
• GMS CM 952: Res Cell & Mol
  
• GMS FA 705: Forensic Anthropology Techniques
  Prereq: consent of instructor. 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. Prince Zinni. 3 cr, Fall sem.
• GMS FA 706: Forensic Anthropological Procedures
  Prereq: Forensic Anthropology and Osteology. This course provides in-depth knowledge of the protocols, methods, and procedures used by forensic anthropologists and entomologists in the recovery of human skeletal material, identification of human skeletal remains and to identify and analysis of types of bone and soft tissue trauma and the stages and processes of human decomposition. In addition, students will have gained experience in the identification and classification, timing and nature of trauma to bones and the estimation of time since death. Prince Zinni. 3 cr, Fall sem.
• GMS FA 708: Homicide Invest
  

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