Courses

• GMS BT 540: Regulatory and Compliance Issues
  Clinical research is conducted to meet the needs of the intended patient population with an investigational medical intervention. But a favorable medical outcome is not the only criterion that is used to judge whether a product can be marketed. Clinical research needs to meet the rigorous standards of the regulators, the ethicists, and the auditors. This course reviews the laws that are in place that are designed to guide the complexities of clinical research. We will use case studies to illustrate what can really happen when clinical studies are conducted -- you may be surprised with what you find. Using group activities and exercises, we will explore the options and approaches used to manage these clinical research issues. 4 cr.
• GMS BT 550: Clinical Data Management
  Introduces students to the technology, process, and responsibilities of clinical data management. Students examine study setup, case report form (CRF) design, and the data life cycle, including data collection, data validation, coding of adverse events using standard dictionaries (such as ICD-9 or MedDRA), data review, and database lock. Data Management SOP's are discussed within this context. An industry-leading clinical data management system (CDMS) is utilized. Students also explore how new technologies, such as electronic data capture (EDC), affect these processes.
• GMS BT 560: Good Clinical Practices (GCP) in Clinical Research
  This course introduces the international standards for ethical conduct of research and maintaining the highest level of scientific quality when conducting clinical trials. Topics include the regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials; the phases of clinical trials leading up to FDA approval of a new drug or device; and how to get a trial up and running including the selection of qualified investigators, obtaining approval to conduct the study from an ethics committee, and completing the regulatory documentation that is required for getting a site ready to enroll patients. The course also covers ensuring data integrity, handling ethical dilemmas, and reporting of serious adverse events. Case studies, review of current media, and exercises will be used to practice the application of information provided in class and to demonstrate GCP compliance from an industry perspective. Group discussions, individual and group projects, and guest speakers help students learn the practical skills used in the field.
• GMS BT 575: Design and Conduct of Clinical Trials
  Prereq: knowledge of biostatistics. This course covers basic principles and current methodologies used in the design and responsible conduct of clinical trials. Topics include statistical design of clinical trials, sample selection, data collection and management, patient recruitment strategies, adverse event reporting, and compliance monitoring. Practical exercises include writing clinical research protocols and informed consent forms, and designing case report forms.
• GMS BT 591: Biomedical Externship
  for Fall and Summer 1 semesters. The externship is the capstone project of the Bachelor of Science degree in the BLCS program. The externship objectives are for students to apply knowledge gained from coursework, learn new and challenging biomedical skills and procedures, and understand the purpose for performing these. In addition, students are expected to articulate the goals of their project and how their project fits within the overall mission of the host institution or department. Students also need to demonstrate initiative and curiosity, and be proactive in researching and learning the science behind their project. Directed study for matriculated students only; register via the program director.
• GMS BT 592: Biomedical Externship
  for Spring and Summer 2 semesters. The externship is the capstone project of the Bachelor of Science degree in the BLCS program. The externship objectives are for students to apply knowledge gained from coursework, learn new and challenging biomedical skills and procedures, and understand the purpose for performing these. In addition, students are expected to articulate the goals of their project and how their project fits within the overall mission of the host institution or department. Students also need to demonstrate initiative and curiosity, and be proactive in researching and learning the science behind their project. Directed study for matriculated students only; register via the program director.
• GMS BT 594: Clinical Research Practicum
  for Fall and Summer 1 semesters. Prereq: 16 credits in clinical research. Directed study offering direct experience with the conduct of a clinical trial. Student will work on a supervised project within an approved clinical research site. For matriculated students only; register via the program director.
• GMS BT 595: Clinical Research Practicum
  for Spring and Summer 2 semesters. Prereq: 16 credits in clinical research. Directed study offering direct experience with the conduct of a clinical trial. Student will work on a supervised project within an approved clinical research site. For matriculated students only; register via the program director.
• GMS BY 762: Foundations of Structural Biology I
  This graduate-level course provides a thorough grounding in the theory and major experimental methods of Structural Biology. The Fall semester (BY762) covers x-ray crystallography and electron microscopy. The Spring semester (BY763) covers NMR, protein thermodynamics, and spectroscopy. Semesters are independent and may be taken in either order. 2 cr, Fall sem.
• GMS BY 763: Foundations of Structural Biology II
  This graduate-level course provides a thorough grounding in the theory and major experimental methods of Structural Biology. The Fall semester (BY762) covers x-ray crystallography and electron microscopy. The Spring semester (BY763) covers NMR, protein thermodynamics, and spectroscopy. Semesters are independent and may be taken in either order. 2 cr, Spring sem.
• GMS BY 776: Macromolecular Assemblies I
  This graduate course covers the concepts of the assembly of biomacromolecules, their structure and stabilizing forces, and biological function as related to structure. Examples are drawn from assemblies of proteins, lipids, lipoprotein systems, membranes and viruses. The Fall semester (BY776) covers protein assemblies, protein-nucleic acid assemblies, and membrane proteins. The Spring semester (BY777) covers lipid-protein assemblies. Semesters are independent and may be taken in either order. 2 cr, Fall sem.
• GMS BY 777: Macromolecular Assemblies II
  This graduate course covers the concepts of the assembly of biomacromolecules, their structure and stabilizing forces, and biological function as related to structure. Examples are drawn from assemblies of proteins, lipids, lipoprotein systems, membranes and viruses. The Fall semester (BY776) covers protein assemblies, protein-nucleic acid assemblies, and membrane proteins. The Spring semester (BY777) covers lipid-protein assemblies. Semesters are independent and may be taken in either order. 2 cr, Spring sem.
• 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 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.

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