Biomedical Laboratory & Clinical Sciences

• 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.
• 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.
• 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.
• GMS BT 575: Design and Conduct of Clinical Trials
  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 will include clinical research protocol and informed consent form writing as well as design of case report forms. [4 cr.]
• 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
• 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.
• 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.
• 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.
• 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.

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