Clinical Research Undergraduate Certificate

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 clinical research. Student learn the analysis and construction of medical words within a context of scientific concepts. After the basics, students learn the anatomy and diseases of the following systems: male and female reproductive, cardiovascular, respiratory, and blood.   [ 2 cr. ]

Continue building your medical vocabulary as you learn the anatomy and diseases of the following systems: digestive, urinary, lymphatic/immune and endocrine. 2 cr.   [ 2 cr. ]

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. ]

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. ]

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. ]

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. ]

Prereq: Chem II and Molecular Biology. This course explores the drug discovery and development process, from which disease pathway 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. These include DNA/RNA- and protein based therapeutics, gene therapy and stem cell based therapy. Other topics covered are ?lead optimization? and selection of drug candidates for pre-clinical testing. A hands-on laboratory component will give students practical skills while reinforcing knowledge gained during lectures.   [ 4 cr. ]

Prereq: Chem II and Molecular Biology. This course will examine how drugs developed at the laboratory bench become a focus of clinical trials and subsequently make it to the market. Topics will include review of molecular and pathophysiological aspects of several diseases and explore the basis for drug design, pre-clinical and clinical testing. Additional topics will include current technologies, clinical evaluation, regulatory approval of biological drugs, and frontiers in translational research. Lectures will be combined with discussions and paper presentations on relevant topics.   [ 4 cr. ]

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. ]

This course description is currently under construction.  [ 4 cr. ]

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. ]

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. ]

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. ]

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.]  [ 4 cr. ]

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. ]