(FALL 2009)

Clinical Data Management (Section 1) MED X413.43  (1.5)

An elective course in the Certificate Program in Clincial Trials: Medical Device and Drug Development.
TEXTBOOK REQUIRMENTS-Required Materials: 2009 CFR/ICH GCP Reference Guide (Perfect Bound), which can be bought at http://www.barnettinternational.com/EducationalServices_Publication.aspx?p=7008 The Barnett Educational Services
Learn about the handling, processing, storage, retrieval, and electronic submissions of clinical data. Gain an understanding of the issues and implications surrounding database setup and the data management process. Enhance your knowledge of applicable FDA regulations (Part 11) and guidelines, and the documentation necessary to achieve FDA compliance. The course will be of interest to clinical data management professionals, clinical research coordinators, clinical research associates, project managers, and programmers who support the design and development of clinical databases. Prerequisite: Knowledge of the medical product development process, including a basic understanding of clinical trials and the role of the FDA. Provider approved by the California Board of Registered Nursing, Provider Number 00093, for 15 contact hours. See enrollment confirmation for login information.

Jody L. Errandi, M.S., is the director of clinical affairs at MiCardia Corporation. She has worked in clinical research managing clinical trials for investigational devices/pharmaceuticals for physicians, surgeons, and medical device companies since 2000. Errandi's experiences and expertise in the area of clinical research management highlight the course.