Clinical Investigation
List of Courses

GMS CI 630 Introductory Pharmacology

Prereq: consent of instructor.   Principles of pharmacology are covered and mechanisms of action and clinical pharmacology are addressed, including the drug development process, drug delivery systems, and population variability in drug response.   Learning objectives include competency in evaluating studies of clinical pharmacokinetics and efficacy. Walsh. 4 cr, 2 nd sem.

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, 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 on-the-job situations, and a final presentation to share the learning with the entire class. Halloran. 4 cr, 1 st 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, diagnostics, and devices. Intended for those interested in regulatory affairs or in the clinical evaluation, development, manufacture, testing and/or commercialization of these products. Provided and in-depth review of the pertinent FDA regulations and guidelines and links these to the scientific and logistical activities involved in taking a product from research to market. Content and preparation of regulatory submissions, including an Investigation 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.  International requirements for health care products are also reviewed. Gloff   4 cr, 1 st sem

GMS CI 660 Good Clinical Practices in Clinical Research

Prereq: consent of instructor. Introduces regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials. Practical information and exercises are designed on GCP compliance fro m an industrial perspective. Topics include: selecting qualified investigators; obtaining ethical approval for patients, and initiating sites successfully. Group discussions and guest speakers help students learn practical skills.  Halloran. 4 cr, 1 st sem.

GMS CI 670 Biostatistics with Computer

Prereq: consent of instructor. This course is designed for Clinical Research Associates and other 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; experimental design; t-tests; correlation and regression analysis; and analysis of contingency tables. Laboratory course. Rose   4 cr, 1 st sem.

GMS CI 675 Design and Conduct of Clinical Trials  

Prereq:   Biostatistics.   Covers the history and current methodologies used in the design and conduct of clinical trials.   Topics include sample selection, data forms and management, patient recruitment, enrollment, and compliance, cost measures and effectiveness.   TBA.   4 cr, 2 nd sem.

GMS CI 691, 692 Directed Studies in Clinical Investigation

TBA, 4cr, 1 st and 2 nd sem.

GMS MS 790 Seminar in Clinical Investigation   Prereq:   consent of instructor.   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 trials.   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.   Broitman, Franzblau, Moore, O’Bryan. 2 cr, 2 nd sem.

GMS MS 961, 962 Clinical Investigation Practicum    var cr, 1 st