UC Irvine Extension Offers Clinical Data Management

Business Wire, July 30, 2008

New Online Course to Provide Overview of Database Setup, FDA Regulations and Guidelines

IRVINE, Calif. -- The University of California, Irvine Extension, announces a new course for clinical data management professionals, clinical research associates, project managers, and programmers who support the design and development of clinical databases. The new course, "Clinical Data Management," will be offered online from Oct. 6 to Nov. 16.

"The handling, processing, storage, retrieval and electronic submissions of clinical data is at the heart of a successful clinical trial," explains course instructor, Jody L. Errandi, M.S., a director of Clinical Affairs at Micardia Corporation. "Students in this course will gain an understanding of these issues and implications surrounding database set-up and the data management process."

Students taking this course will learn how to identify applicable FDA regulations that satisfy data compliance as well as the data elements required in for creating clinical trials databases. Students will acquire a general knowledge of how and why data is collected in a clinical trial and will be able to create case report forms using basic knowledge learned in the class. The course will enhance knowledge of applicable FDA regulations and guidelines and the documentation necessary to achieve FDA compliance.

Course instructor Errandi has worked in clinical research managing clinical trials for investigational devices and pharmaceuticals for physicians, surgeons, and medical device companies since 2000. Her experiences and expertise in the area of clinical research management highlight the course.

"Clinical Data Management" is part of UC Irvine Extension's "Clinical Trials: Medical Device and Drug Development Certificate Program." For more information about the course or the certificate program, contact Rogelio Rodriguez at (949) 824-5380 or visit www.extension.uci.edu.

About the University of California, Irvine Extension: As the continuing education arm of UCI, UC Irvine Extension is dedicated to providing a university-level learning experience for students, offering thousands of exciting courses and programs to local, regional, and global constituencies. UC Irvine Extension offers a rich array of academic and community programs to support a diverse audience, from a wide selection of academic programs to numerous campus activities. For more information, please visit www.extension.uci.edu.

About the University of California, Irvine: The University of California, Irvine is a top-ranked university dedicated to research, scholarship and community service. Founded in 1965, UCI is among the fastest-growing University of California campuses, with more than 27,000 undergraduate and graduate students and about 1,400 faculty members. The second-largest employer in dynamic Orange County, UCI contributes an annual economic impact of $3.3 billion. For more UCI news, visit www.today.uci.edu.