Courses

• GMS BN 891: Case Studies
  2 cr, Fall & Spring sem.
• GMS BN 892: Case Studies
  2 cr, Fall & Spring sem.
• GMS BN 893: Child Clinical Neuropsychology
  Covers general theoretical issues (e.g., intrauterine and postnatal development of the brain, handedness and lateralization of function, and recovery of function and neurobehavioral plasticity); diagnostic entities (e.g., attention deficit disorder, effects of early brain damage, developmental language disorders, dyslexia, and effects of malnutrition); and assessment and treatment (development of attention, social, spatial abilities, and language). 4 cr, on demand.
• GMS BN 991: Research in Behavioral Neuroscience
  Var cr, Fall sem.
• GMS BN 992: Research in Behavioral Neuroscience
  Var cr, Spring sem.
• GMS BY 760: Foundations of Structural Biology, A and B
  The course provides thorough grounding in theory and practice of the major, fundamental methods of biophysics and structural biology. The course covers thermodynamics, spectroscopy, electron microscopy, x-ray diffraction and crystallography, and nuclear magnetic resonance from the standpoint of modern molecular and structurally based research. 2 cr each, Fall & Spring sem, in either order.
• GMS BY 771: Macromolecular Assemblies, A and B
  Assembly of biomacromolecules, their structure and stabilizing forces; biological function as related to structure, with examples drawn from assemblies of proteins, lipids, lipoprotein systems, nucleic acid/protein assemblies, and membranes. 2 cr each, Fall & Spring sem, in either order.
• GMS BY 871: Biophysics Special Topics/Student Seminar
  A weekly program in which students present seminars on assigned or selected current scientific literature, and learn grant-writing skills. Emphasis is placed on class participation by all students. 2 cr, Fall & Spring sem.
• GMS BY 872: Biophysics Special Topics/Student Seminar
  A weekly program in which students present seminars on assigned or selected current scientific literature, and learn grant-writing skills. Emphasis is placed on class participation by all students. 2 cr, Spring sem.
• GMS BY 945: Research Biophysics
  Var cr
• GMS BY 946: Research Biophysics
  Var cr
• GMS CI 631: The Management of Clinical Research
  This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles with an explanation and analysis of selected portions of the Code of Federal Regulations (CFR), applicable to clinical research during the new drug development process. The case study approach is used in this course since the drug development industry translates these regulations into both written and unwritten standards, practices, and guidelines. Each session will use activities to expand the interpretation of the regulations, into an operational and organizational focus, further integrating real-life issues into the classroom. In order to ensure that classroom learning is linked with the students' work experiences, there will be an outside project required which will incorporate the course work with the simulated on-the-job situations, and a final presentation to share the learning with the entire class. 4 cr, Spring sem.
• 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, Summer II 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 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.

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