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A quality system encompasses the organizational structure, responsibilities, procedures, processes, and resources that are necessary to implement quality management.9 This approach was standardized by the International Organization for Standardization (ISO) and is applicable across many industries, including clinical research. A quality system approach advocates an infrastructure that provides the flexibility to account for study differences in a controlled and consistent manner. Although not mandated for all clinical studies, a quality system approach has been adopted by the FDA in medical device regulations.10
Copyright 2013 Society For Clinical Data Management - Page 4 of 20 - Assuring Data Quality
Good Clinical Data Management Practices
Every study should establish an appropriate minimum level of quality, which should be determined through planned analyses specified in the protocol or statistical analysis plan. The assessment of data quality needs should address the study’s purpose, characteristics and complexity.5 A key concept of the quality system approach is that the structure, format, content, and method of presentation of documented procedures are contingent upon the needs of the organization.9 Most organizations involved with clinical research already have some components of a quality system in place, for example, policies and procedures.
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