Biomedical Laboratory & Clinical Sciences
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GMS BT 480: Planning and Operations in Clinical Research
Prereq: BT 560 (GCP), BT 575 (Design & Conduct of Clin Trials) or consent of program director. This course integrates a comprehensive review of the good clinical practice core principles and project management strategies applicable to clinical research. Through lectures, case studies and discussions, students examine the concepts and applied techniques for cost estimation, budgeting, allocation of resources, risk management and quality assurance for clinical research projects. Project management principles and methodologies are discussed with a special focus on planning, controlling, and coordinating individual and group efforts.
GMS BT 484: Advanced Cell Culture Techniques
Prereq: one semester of biology, two semesters of chemistry, BT 454 (Cell Culture) and BT 413 (Mol Bio) or consent of program director. Cell culture has become an indispensable tool for all areas of biomedical science.Â In the course, students develop the necessary routine for work in a cell culture lab by passaging cell lines throughout the course and determining growth characteristics under different conditions. At the same time, students isolate and analyze biomolecules from these cell lines and perform experiments using advanced techniques, such as transfections, reporter gene assays, as well as a variety of optical assays (absorbance, luminescence, and fluorescence assays). At the end of the course, students communicate their work and results during a poster session. Laboratory course.
GMS BT 520: Biology of Cancer
Prereq: BT 405 (Biochem) and BT 413 (Mol Bio) or consent of program director. This course focuses on the cellular and molecular changes that underlie the development and progression of human cancer. Students examine the pathways and processes that involve oncogenes and tumor suppressor genes to understand how they can contribute to cancer. Complex interactions including angiogenesis, tumor immunology, invasion and metastasis are studied as well. In addition,the course covers targeted approaches to cancer therapy and the latest scientific research including cancer epigenetics, microRNAs and cancer stem cells.
GMS BT 530: Introductory Pharmacology
Prereq: one semester biology and 2 semesters of chemistry, BT405 recommended. This course introduces the basic principles of pharmacology and several major classes of therapeutic agents, with attention to their mechanisms of action. Issues of current and future directions in pharmacology are addressed including the source of information about pharmacologic agents, the ethics of human experimentation, the drug development process, and new biotechnological approaches to drug design.
GMS BT 532: Histopathology
Prereq: BT 104 (Med Term) and BT 342 (Cell Bio), or consent of program director. The goal of the course is to give students a fundamental knowledge and practical experience of human histology, pathology and the techniques used to study cells and tissues in the normal and diseased state. This course familiarizes students with biospecimen processing and management at the organ, tissue, cellular and molecular levels. By studying different organs and organ systems, including: gastrointestinal, breast, respiratory, neuro-muscular, skin, brain, kidney and liver, students develop an understanding of the normal and diseased state at the macro and microscopic levels. Furthermore, the course provides hands-on experience, including: dissection, preservation, processing, microtomy, photomicroscopy, macro-photography, electron microscopy, and archiving. Students apply their understanding of medical terminology and cell biology. This course can help prepare a student for graduate work in pathology, for a Pathologists' Assistant program or for a career as a histotechnologists in a diagnostic or research laboratory. Â Laboratory course.
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 regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials. Practical information and exercises are designed for the clinical trial professional on procedures for ensuring GCP compliance from an industry perspective. Topics include identifying and selecting qualified investigators, obtaining ethical approval to enroll patients, and initiating sites successfully. The course also covers issues related to collecting required regulatory documentation, verifying high quality data, maintaining study materials accountability, and reporting serious adverse events. Group discussions 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. Directed study for degree candidates only. Prereq: Consent of program director. 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.
GMS BT 592: Biomedical Externship
for Spring and Summer 2 semesters. Directed study for degree candidates only. Prereq: Consent of program director. 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.
GMS BT 594: Clinical Research Practicum
for Fall and Summer 1 semesters. Prereq: 16 credits in clinical research and permission of program director. 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.
GMS BT 595: Clinical Research Practicum
for Spring and Summer 2 semesters. Prereq: 16 credits in clinical research and permission of program director. 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.