Clinical Data Management Course Offered by UC Irvine Extension; Class Prepares Professionals for System-Critical Database Setup and Management.

IRVINE, Calif. -- In response to a growing national demand by healthcare organizations, hospitals, clinics and medical professionals for effective ways to integrate and manage medical records, UC Irvine Extension is offering a two-day course on clinical data management. The course will focus on the issues and implications surrounding database setup and the data management process.

"The implementation of clinical data information systems is crucial to the continued success of our healthcare system," said Rogelio C. Rodriguez, director of engineering and science programs for UC Irvine Extension. "Effective data management has an enormous impact on productivity and patient safety."

The course is designed for clinical data management professionals, clinical research coordinators, clinical research associates, project managers, and programmers who support the design and development of clinical databases. Participants will learn about the handling, processing, storage, retrieval, and electronic submissions of clinical data. They will also gain an enhanced knowledge of applicable Food and Drug Administration (FDA) regulations and guidelines, and the documentation necessary to achieve FDA compliance.

The clinical data management course will be taught by Michael R. Hamrell, Ph.D., president of MORIAH Consultants, a regulatory affairs/clinical research consulting firm. Hamrell has worked in drug development, clinical research and regulatory affairs for more than 20 years. He has worked in pharmaceuticals, contract research, government, and biotech industries, as well as in domestic and international regulatory affairs and clinical research. Hamrell serves on the editorial board of both the Clinical Trials Advisor and the DIA Forum, and is editor-in-chief of the Drug Information Journal.

"The benefits to be gained by learning how to effectively manage clinical data are enormous," said Hamrell. "Once various medical systems are integrated and data can be shared, the increased level of communications, security and privacy all combine to reduce the possibility of errors and improve relations between medical facilities, patients and physicians."

Upon completion of the course, students will be able to accomplish the following:

--Identify applicable FDA regulations that satisfy data compliance

--Discuss issues and implications surrounding database utilization and organization

--Acquire general knowledge of clinical data management and the processes involved

--Describe the importance of data management to the successful execution of a clinical trial

--Utilize a nursing knowledge base to complement the data management aspects of the clinical trial process

Prerequisites for attending the course are the knowledge of the medical product development process and a basic understanding of clinical trials and the role of the FDA. This course is provider-approved by the California Board of Registered Nursing, provider number 00093, for 15 contact hours.

UC Irvine Extension is offering the two-day clinical data management course on Saturday, Nov. 12 and Saturday, Nov. 19 from 8:30 a.m. to 5 p.m., at the UC Irvine Learning Center in Orange, Calif. The fee is $285; class registration number is 00225. For more information or to enroll, please visit www.extension.uci.edu or call 949-824-6538.

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. For more information about UC Irvine Extension visit www.extension.uci.edu.