The Clinical Data Interchange Standards Consortium Laboratory Model: Standardizing Laboratory Data Interchange in Clinical Trials

摘要

The Laboratory Data Standards Model team of the Clinical Data Interchange Standards Consortium (CDISC) has defined a model for representing, in a standardized manner, the laboratory data generated during the conduct of clinical trials. The CDISC Laboratory Data Standards Model is the first step in proposing independent standards for the interchange of clinical trial laboratory data. Standards will decrease the time and resources that are required to exchange data by stakeholders in the pharmaceutical development process. Cost containment and improved data quality should result from the adoption of such a standard for interchanging laboratory data.