Clinical Investigation

• GMS CI 631: Clinical Trials Management
  Prereq: consent of instructor. This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles with 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. Halloran, Roth. 4 cr, Spring sem.
• 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
  

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