Biomedical Laboratory and Clinical Sciences Undergraduate Courses

Courses offered in the upcoming semester are specified in the list below.

  • GMS BT 104 Medical Terminology

    Understanding medical terminology is fundamental for anyone working in the sciences. It is the language of the technician or researcher involved in biotechnology, biomedical investigations, or health services. Teaches the analysis and construction of medical words within a context of scientific concepts. Topics covered include anatomy, blood, cancer medicine, biotechnology, and pharmacology.   [ 2 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Phillips T 5:30 PM - 8:30 PM
  • GMS BT 106 Medical Terminology II

    Continue building your medical vocabulary as you learn the anatomy and diseases of the following systems: digestive, urinary, nervous (including sense organs), integumentary (skin), and endocrine.   [ 2 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 110 Introduction to Biomedical Laboratory Sciences

    Provides a theoretical and practical foundation in laboratory science. Students are introduced to the scientific method, laboratory mathematics, chemistry, biochemistry, cell and molecular biology, and immunology. Students learn hands-on solution making, electrophoresis, protein quantitation and other commonly used laboratory methods. Emphasis is placed on lab safety, proper handling of instruments, careful following of written instructions for lab procedures, maintenance of lab notebooks, and data collection, presentation and analysis. Laboratory course.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 160 Biotechnology I

    Biotechnology I introduces students to the basic sciences of biotechnology (cell biology, immunology, DNA/molecular biology) and describes DNA technologies used in gene therapy and microarray technology and in the production of recombinant protein drugs, antibodies, vaccines, and transgenic animals/plants. The challenges of bringing protein drugs from R&D through large scale manufacturing and the FDA approval process are also discussed.   [ 2 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Trombino W 5:30 PM - 8:30 PM
  • GMS BT 170 Biotechnology II

    Biotechnology II focuses on the applications of biotechnology to medicine and other disciplines. Through a combination of lectures, videos, readings of scientific articles, class discussions and presentations, students explore recent developments in the biotech industry. Topics can include stem cell therapy and animal cloning, novel drugs and vaccines for emerging infectious diseases, immunotherapies to treat cancer, and the potential of genomics, proteomics and pharmacogenomics to identify drug targets and identify disease processes.   [ 2 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Trombino 670 W 5:30 PM - 8:30 PM
  • GMS BT 201 Anatomy and Physiology I

    This course provides a practical understanding of anatomic structures and coordinates this knowledge with the various functions of the human body. We will also explore regulatory processes that integrate cells, tissues, organs and systems. Topics include: organization of the body, tissue development, cellular structure and function as well as the integumentary (skin), skeletal, and muscular systems. The last third of the course focuses on the nervous system. The course will incorporate clinical material throughout, and laboratory exercises will correlate with the lecture material.   [ 4 cr.]

    Prereq: knowledge of biology

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 202 Anatomy and Physiology II

    This course is the second half of an intensive sequence designed to integrate the structure with the function of the human body. The course covers the endocrine, cardiovascular, lymphatic and immune, respiratory, digestive, urinary and reproductive systems. Students will study these systems as they relate to homeostasis and clinical disorders. Laboratory exercises on each system will be incorporated into the course materials.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Greenwald L R 5:30 PM - 8:30 PM
  • GMS BT 208 Essential Math for Biotech

    This course focuses on the fundamental math widely used in the biotech industry in buffer preparation, cell culture, protein analysis, molecular biology, microbiology, and other disciplines. Topics include scientific notation, metric system, dilutions, logarithms, significant figures, graphs and other methods of data presentation, basic statistics in data analysis, and strategies for solving word problems. This math is essential for students planning to take laboratory-based courses including BT 110, 413, 414, 426, 454 and 484.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 210 Technical Writing in Clinical Research

    Technical Writing for Clinical Research introduces students to the structure, content, and regulatory requirements of documents created for the clinical research industry. The course reviews the FDA regulations and ICH guidances for drug, device and biologic documents, AMA Manual of Style Guidelines, and common industry standards. Students will learn to compose study abstracts, clinical protocols, informed consent forms, and clinical study reports.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 220 Principles of Instrumentation

    This course introduces students to laboratory instrumentation fundamentals. Topics include: safety; the measurement of viscosity, melting point, and refractive index. We will also explore chromatographic instruments (gas and high pressure liquid); fundamentals of method development; infra-red (IR), and nuclear magnetic resonance (NMR) principles. Statistical methods and the analysis of errors will be reviewed. Course format will include readings and presentations. (First eight weeks).   [ 2 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 240 Current Good Manufacturing Practices and Quality Assurance

    Provides a detailed knowledge of the role of Current Good Manufacturing Practices (CGMPs) and a Quality Department in the development and manufacture of biopharmaceutical products. Topics include the goals and obligations of the Food and Drug Administration, a review of the CGMP subparts, and the responsibilities of a Quality Department in ensuring product quality.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND O'connor T 5:30 PM - 8:30 PM
  • GMS BT 280 Office Applications in the Laboratory

    This course focuses on the management and presentation of information and data useful in laboratory research. Basic statistical concepts will be introduced and explored. Database concepts and principles will be covered while examining the differences between data and information. Students will also learn presentation development and techniques, using instructional design principles to create presentations on laboratory projects and experimental data. Students will complete laboratory projects using Microsoft Excel for statistical analysis, Microsoft Access for database management and Microsoft PowerPoint for presentation development.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Parkin W 5:30 PM - 8:30 PM
  • GMS BT 305 Introductory Biochemistry

    This course is for undergraduate students familiar with chemistry and biology. An overview of biochemistry is provided to prepare students for medical school or for advanced undergraduate or general graduate science courses. Topics covered include protein structure and function, nucleic acid structure and function, enzymatic catalysis, and metabolism. Some laboratory work; no lab fee.   [ 4 cr.]

    Prereq: one year of college biology and one year of college chemistry.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 320 Laboratory Automation and Robotics

    This course introduces students to laboratory automation fundamentals. Topics include: non-robotic automated work stations; robotic workstations and systems; high throughput technologies and Laboratory Information Management Systems (LIMS) for lab automation. Optimization of organic process chemistry in automated systems (fundamentals of statistical design of experiments) will be reviewed. Course format will include readings and presentations. (Second eight weeks).   [ 2 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 330 Medical Devices

    This course will provide students with an introductory overview of the world of medical devices, from bandages to defibrillators. We will explore what the applicable regulations are, starting with the FDA, and how companies use these regulations to guide the design, development, and marketing of their products. Most classes will contain an interesting mix of “rules, realities, and renegades,” that includes a unique component called, “At the Drugstore,” where students will focus an educated eye on commonly found items on the shelf. In addition, students will learn about jobs and career opportunities within the medical device industry and how to gain entry into the field.   [ 4 cr.]

    Prereq: MET BI 105 and MET CH 171; or equivalent or consent of instructor.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Tobia L S 9:00 AM - 12:00 PM
  • GMS BT 336 Bioinformatics

    This course explores the use of bioinformatics databases and software as research and educational tools. Students will use data mining tools to extract DNA and protein sequences from primary and secondary databases. Software tools will be used to compare and analyze these sequences and construct gene and protein models for solving research problems related to molecular evolution, drug discovery and genetic bases for development and disease.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 342 Cell Biology

    This course will introduce students to eukaryotic cell structure and function. Topics include membrane structure, intracellular organelles, control of gene expression, cell motility and transport, cell communication and signaling, cell cycle and apoptosis, and differentiation. Students will explore the field of cell biology through readings and presentations.   [ 4 cr.]

    Prereq: GMS BT 413 & GMS BT 405, or equivalent, or consent of the instructor

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Agarwal L T 5:30 PM - 8:30 PM
  • GMS BT 360 Auditing in Clinical Research

    Clinical research auditing ensures that the rights, safety, and well being of the study subject have been protected and the clinical study data are credible. Auditing clinical trial activities provides the strict oversight of performance with the ultimate goal of having a successful submission and identifying opportunities for improvement. In this practical course, students will learn how to prepare and conduct audits, write audit observations, create an audit report and review audit report responses. In addition, students will learn how to manage audits by an outside agency. Good Clinical Practice (GCP) guidelines and regulatory requirements will be reviewed along with exploring the concept of a quality system and the writing of audit program Standard Operating Procedure (SOP). Developing an audit plan will be an emphasis. Group discussions and role- playing will be used to develop practical audit techniques. This class should prepare a student for an introductory auditing position within clinical research.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 404 Medical Virology

    Focuses on techniques used to isolate and identify viral pathogens associated with human disease. Through a series of lectures, the student takes a functional approach to this subject. Covers the biology, the immune response to viral infections, the genetics of viral replication, and viral pathogenesis.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 405 Biochemistry

    Biochemistry is the perfect melding of basic biology and chemistry. This course focuses on the study of life at the molecular level. We will first look at the structure and function of biomolecules including proteins, carbohydrates, lipids, and nucleic acids. Secondly, we will analyze how biological information is stored and transferred in the cell. We will then learn about bioenergetics and the importance of energy flow in living cells and organisms.   [ 4 cr.]

    Prereq: One semester of biology, one semester of chemistry and knowledge of organic chemistry is helpful, but not required.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Rankin W 5:30 PM - 8:30 PM
  • GMS BT 406 Clinical Laboratory Genetics I: Cytogenetics

    Advanced course designed for those considering a clinical or research career in human genetics. Emphasis is on clinical cytogenetics (chromosome testing). Course will cover types of chromosome abnormalities, methodology, nomenclature and clinical significance in pregnancy, birth defects, and cancer. Laboratory work will include basic blood culture, chromosome preparation, banding, identification and karyotyping. Course will provide updated review of latest cytogenetic methodology and applications, such as FISH, comparative genomic hybridization (CGH) and array CGH lab   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 407 Clinical Laboratory Genetics II: Molecular Genetics

    Advanced course designed for those considering a clinical or research career in human genetics. Emphasis is on clinical molecular genetics (DNA testing). Course will cover types of genetic abnormalities, methodology, nomenclature and clinical significance in pregnancy, birth defects, and cancer. Laboratory work will include basic blood extraction, DNA preparation, gel electrophoresis, capillary electrophoresis, sequencing, and identification. Course will provide updated review of latest molecular genetic methodology and applications, such as copy number analysis, chip based sequencing and next generation sequencing.   [ 4 cr.]

    Prereq: GMS BT 406 or equivalent or consent of instructor.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 408 Immunology Lecture

    This course emphasizes the molecular and cellular interactions involved in immune response. Topics covered include antibody structure and function; applications of monoclonal antibodies in biotechnology and medicine; gene rearrangements in B and T cells; cellular cooperation and the role of MHC; tolerance; and immunopathology (hypersensitivity, autoimmunity, transplantation, AIDS, cancer immunity and immunotherapy).   [ 4 cr.]

    Prereq: one year of college biology and one year of college chemistry.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 409 Immunology Laboratory

    This course will introduce students to laboratory techniques based on immunologic assays commonly used in biological and biomedical research labs. Techniques covered include Flow Cytometry (FACs), ELISA, cell sorting, cell proliferation, cell death, and migration assays. This is a practical lab course, with approximately 1/2 hour of lecture followed by 2 1/2 hours in the laboratory each class   [ 4 cr.]

    Prereq: GMS BT 408 and GMS BT 454; or equivalent, or consent of instructor.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 411 Techniques in Protein Purification and Analysis Lecture

    Familiarizes students with the theory and application of many biochemical techniques involved in protein purification and characterization, such as chromatography (HPLC, ion exchange, gel permeation, hydrophobic affinity), electrophoresis (followed by blotting techniques), and amino acid analysis. Students learn to think critically about methodology, design a purification scheme, scale it up, and troubleshoot an existing plan. Special problems with recombinant proteins are also covered.   [ 4 cr.]

    Prereq: GMS BT 413, GMS BT 305/405, or equivalent, or consent of instructor

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 412 Techniques in Protein Purification and Analysis Laboratory

    This laboratory course will cover a wide variety of conventional methods for protein isolation, purification, and characterization. Training will be provided in experimental design and approaches for isolating and purifying proteins - including selection of tissues, subcellular fractionation, analytical ultracentrifugation, isoelectric focusing, two-dimensional gel electrophoresis, ion exchange chromatography, gel filtration, hydrophobic interaction chromatography, SDS-PAGE, and affinity chromatography. The goals of the course are to introduce the most important and useful concepts of protein purification and handling and to help students to develop an insight about how to work with proteins.   [ 4 cr.]

    Prereq: GMS BT 411; concurrent, or equivalent.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 LAB Thoidis T 5:30 PM - 8:30 PM
  • GMS BT 413 Techniques in Molecular Biology

    Students learn the fundamentals of isolation, in vitro translation, DNA and genomic cloning, and the characterization and utilization of DNA clones. Students learn to think critically about research methodology and selection of appropriate techniques to achieve objectives. Introduces basic molecular biology techniques and interpretation of results. Topics include DNA restriction analysis, gel electrophoresis, isolation of DNA from E. coli, construction of recombinant DNA, molecular, and Southern blot analysis. Introduces basic molecular biology techniques and interpretation of results. Topics include DNA restriction analysis, gel electrophoresis, isolation of DNA from E. coli, construction of recombinant DNA, molecular, and Southern blot analysis.   [ 4 cr.]

    Prereq: a working knowledge of biology and chemistry.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 426 Medical Microbiology

    Provides the student with an understanding of clinically important microorganisms. Students become familiar with the classification, pathogenicity, identification, and prevention and treatment of diseases caused by bacteria, fungi, and parasites as well as the workings of a modern clinical microbiology laboratory. Laboratory course.   [ 4 cr.]

    Prereq: MET BI 105 and MET CH 171; or equivalent, or consent of instructor.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 436 Human Genetics

    This course focuses on mammalian genetics and DNA structure and analysis. It is intended for students interested in pursuing a career in laboratory research in an academic or industrial setting. Topics include the molecular basis of human genetic disease, DNA structure and analysis, utilization of human genome project data, and use of Internet-based bioinformatics tools. The class includes lectures, research laboratory tours, and student presentations.   [ 4 cr.]

    Prereq: MET BI 105 or equivalent and GMS BT 305/405 or equivalent and Internet browser access.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 440 Genetics, Ethics, and the Law

    This online class will explore the newest information in human genetics and its legal and bioethical implications. Human genetics is the most explosive field in medicine today and its present and future involve legal and ethical decisions only imagined today. The decisions that come from the issues will be presented to professionals and lay people alike. Using audio-visuals, actual cases, discussion and lecture, this class examines cases that come straight from the headlines. Topics covered include: new reproductive techniques, genetic diseases, prenatal testing and genetic testing, DNA fingerprinting, cloning, and DNA technology.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    OL IND Yashon ARR -
  • GMS BT 442 Issues in Assisted Reproduction

    This on-line course explores the new world of assisted reproduction. Students will examine cases for their ethical and legal implications. Web sites and readings will be provided so students can synthesize information into thoughtful analyses. Topics will include in vitro fertilization, surrogacy, frozen embryos, and gene manipulation. The entire process is taught on-line. Assignments, including case analyses, quizzes and papers, will turned in over the Internet. Online course only.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 443 Advanced Molecular Biology Lecture

    This course evaluates how cutting-edge technologies in molecular biology contribute to unraveling gene function and biological processes. Students read, discuss and present original research papers about transcriptional regulation, intracellular signaling pathways, cell cycling, apoptosis, cancer, and DNA repair. Technologies discussed include microarrays, RNA silencing, inducible gene expression systems, reporter gene assays, mutagenesis, use of green fluorescent protein for life cell imaging, the creation of transgenic and knockout animals, the Cre/Lox system, and the use of biological databases. Great opportunity to develop and improve your PowerPoint presentation skills.   [ 4 cr.]

    Prereq: GMS BT 413.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Doerre S M 5:30 PM - 8:30 PM
  • GMS BT 450 Forensic Toxicology

    Explores the role of toxicology in society both as a safeguard to prevent injury from environmental chemicals and a tool in the investigations of suspicious deaths. Case studies, guest speakers, and group discussions will accompany lectures and demonstrations as students also explore the role of legal and medical communities as well as governmental agencies in dealing with issues.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 454 Cell Culture Techniques

    This course gives students a foundation in basic cell culture techniques used in modern cell culture labs. The topics covered will include aseptic technique, freezing and thawing of cell stocks, passage and maintenance of cells, and culture of adherent and suspension cells. Emphasis will be on practical hands-on experience and much of the class time will be devoted to laboratory work. A short lecture introduces relevant information and techniques to be performed in the laboratory. Upon completion of this course, students will be able to function in a cell culture laboratory at the level of a novice technician and be able to understand and follow basic cell culture protocols.   [ 4 cr.]

    Prereq: MET BI 105 and MET CH 171; or equivalent, or consent of instructor.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 LAB Seidl M, R 5:30 PM - 8:30 PM
  • GMS BT 460 Drug Discovery and Biotechnology

    Prereq: Solid knowledge of basic biochemistry, cell biology, and molecular biology techniques. This course explores the drug discovery process from initial decision on which disease pathways to pursue to the evaluation of potential drugs. Methodologies used to identify and validate drug targets will be described with emphasis on biotechnology-based assays and techniques. This course will also cover different types of therapeutics and the options available to drug developers. Emphasis will be placed on the issues and challenges faced in identifying appropriate drug targets and devising studies that accurately validate these targets.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 465 Cell Signaling in Health and Disease

    Many pathological conditions such as diabetes and cancer are caused by perturbations in signal transduction cascades. These cascades convert extracellular signals into changes in gene expression and alterations in cell physiology. Cellular responses result from the integration of many different signals. The proteins that participate in signal transduction cascades interact in a dynamic, regulated fashion to form multi-protein complexes that allow information processing. This course will present the major signal transduction pathways and their crosstalk, as well as their contribution in maintaining cellular homeostasis. In addition, we will highlight perturbations of these pathways that could lead to development of different diseases as well as the molecular logic that underlies current and future therapies.   [ 4 cr.]

    Prereq: GMS BT 305 or GMS BT 405.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 470 Technologies in Clinical Research

    This course explores the multiple technologies that govern key aspects of clinical trial management and regulatory filings. Students will be able to identify the various technologies that are used in the conduct of clinical trials, the regulations that govern their use, and the issues that companies face in deploying the various tools. We will examine a sample company with a clinical portfolio and students will identify the timing, importance, and integration requirements of the various technologies with emphasis on strengths and weaknesses associated with the conduct of the trial.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Rosa W 5:30 PM - 8:30 PM
  • GMS BT 475 Infect Disease

      [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Ilyinskii R 5:30 PM - 8:30 PM
  • GMS BT 484 Advanced Cell Culture Techniques

    Cell culture has become an indispensable tool for all areas of biomedical science. In this course students will develop the necessary routine by taking care of particular cell lines throughout the entire course. At the same time, students will examine their cell lines using advanced techniques, such as transient and stable transfections, reporter gene assays, activation of signaling pathways, induction of cell differentiation, examination of cell cycle and apoptosis, fluorescent microscopy, and FACS analysis. At the end of the course, each group will present their findings during a poster session. Laboratory course.   [ 4 cr.]

    Prereq: MET BI 105 ; MET CH 171 ; GMS BT 110 ; GMS BT 454; or equivalent, or consent of instructor.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 510 Ethico-Legal Issues in Bioscience

    This course examines evolving ethical and legal issues in the biosciences. Students will study existing laws and legal cases pertaining to topics such as genetic testing, gene therapy, and forensic uses of DNA. Class discussions, student presentations, case analyses and in-class lectures will be supplemented with online activities as well as the composition of a legal brief. 4 cr.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 520 Biology of Cancer

    This course will focus on the cellular and molecular changes that underlie the development and progression of human cancer. We will 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 will be studied as well. In addition, we will cover targeted approaches to cancer therapy and the latest scientific research including cancer epigenetics, microRNAs and cancer stem cells.   [ 4 cr.]

    Prereq: GMS BT 413; or equivalent or consent of instructor.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 530 Introductory Pharmacology

    Introduction to the principles of pharmacology including pharmacokinetics and dose/response relationships. Major classes of therapeutic agents are covered with attention to their mechanisms of action. Addresses issues of concern in drug development and the biological bases for population variability in drug response.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Malikova R 5:30 PM - 8:30 PM
  • GMS BT 540 Regulatory and Compliance Issues

    This course explains the regulatory requirements for health care products: drugs, biologics, diagnostics, and devices. The focus is on U.S. FDA regulations and their impact on product development and marketing with international requirements. Recommended for students in clinical research concentration.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 550 Clinical Data Management

    Introduces students to the technology, process, and responsibilities of clinical data management. We will 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 will be discussed within this context. An industry-leading clinical data management system (CDMS) will be utilized. We will also explore how new technologies, such as electronic data capture (EDC), affect these processes.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Pagliuca R 5:30 PM - 8:30 PM
  • GMS BT 560 Good Clinical Practices (GCP) in Clinical Research

    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. 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.   [ 4 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 575 Design and Conduct of Clinical Trials

    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; and measures of cost effectiveness.   [ 4 cr.]

    Prereq: knowledge of statistics.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 580 Legal and Ethical Issues in Clinical Research

    Students examine the development and implementation of regulatory as well as ethical issues involved with conducting clinical trials. Topics include: use of human subjects, privacy and confidentiality, conflicts of interest, use of stem cells in research, federal laws affecting laboratories, and genetic testing of gene and therapy trials. There will also be discussions on landmark legal cases affecting laboratory scientists. 2 cr. summer   [ 2 cr.]

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 591 Directed Study: Biomedical Externship

    Directed study for degree candidates only. Practical, hands-on experience in laboratory setting. Various credits and fee, as arranged with Director.   [Var cr.]

    Prereq: resume writing workshop.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 592 Directed Study: Biomedical Externship

    Directed study for degree candidates only. Practical, hands-on experience in laboratory setting. Various credits and fee, as arranged with Director.   [Var cr.]

    Prereq: resume writing workshop.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Phillips ARR -
  • GMS BT 594 Clinical Research Practicum

    Directed study offering direct exposure to the conduct of a clinical trial. Various credits and fee, as arranged with Director.   [Var cr.]

    Prereq: 16 credits in clinical research and permission of Director.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
  • GMS BT 595 Clinical Research Practicum

    Directed study offering direct exposure to the conduct of a clinical trial. Various credits and fee, as arranged with Director.   [Var cr.]

    Prereq: 16 credits in clinical research and permission of Director.

    Offered: Spring 2010

    Section Type Instructor Location Days Times
    A1 IND Phillips ARR -