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Feature Article

Five VA research centers receive prestigious quality-management certification

The five Data Management and Statistical Coordinating Centers of VA's Cooperative Studies Program recently earned ISO 9001:2008 certification for quality management, an acknowledgement of exceptionally high standards in this area. Program officials said they believed this was the first time a federal clinical research program has achieved this certification at a national level.

ISO refers to the International Organization for Standardization. ISO 9001 is the world's most respected benchmark for quality management. The certification provides objective proof that a business or government agency has implemented an effective quality management system. Currently, VA is seeking ISO certification for all its clinical care programs.

To achieve ISO certification, organizations must meet defined standards that show they have an effective quality system. This includes having a well-documented quality process; demonstrated leadership support and engagement; a method for detecting deviations and correcting them; comprehensive staff training; and a system of managing documents and records for core business practices. VA has been able to meet each of these standards in the research conducted by its Cooperative Studies Program (CSP).

CSP specializes in large-scale, multisite clinical research studies within VA. These efforts are initiated and led by VA clinician-researchers and often involve non-VA partners, such as other federal agencies, pharmaceutical or biotechnology companies, or the public health agencies of other nations. CSP dates back to 1946, when VA initiated drug treatment studies on tuberculosis, then a prevalent disease among Veterans. Numerous landmark CSP studies over the decades have helped advance medical care heart disease, kidney disease, diabetes, stroke, posttraumatic stress disorder, shingles, and many other health conditions affecting Veterans.

CSP's Data Management and Statistical Coordinating Centers provide expertise in areas such as research methodology; management of data, projects, and budgets; and compliance with regulations and policies on clinical research. The centers are located in Boston, Mass.; Hines, Ill.; Palo Alto, Calif.; Perry Point, Md.; and West Haven, Conn. More than 250 VA employees work at the five centers.

Another center associated with CSP, the Clinical Research Pharmacy Coordinating Center in Albuquerque, N.M., received ISO 9001 certification in 2004, and the President's Malcolm Baldrige National Quality Award in 2009. That center provides pharmaceutical management and other resources for CSP studies that involve drugs or devices.

ISO is a global federation of 110 standard-setting institutes that work to promote the growth of manufacturing, trade, and communication among businesses and organizations worldwide through the development of uniform quality standards.

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