title: Metadata registry and management system based on ISO 11179 for Cancer Clinical Trials Information System.
abstract: Standardized management of data elements (DEs) for Case Report Form (CRF) is crucial in Clinical Trials Information System (CTIS). Traditional CTISs utilize organization-specific definitions and storage methods for Des and CRFs. We developed metadata-based DE management system for clinical trials, Clinical and Histopathological Metadata Registry (CHMR), using international standard for metadata registry (ISO 11179) for the management of cancer clinical trials information. CHMR was evaluated in cancer clinical trials with 1625 DEs extracted from the College of American Pathologists Cancer Protocols for 20 major cancers.
authors.affiliation: Seoul National University Biomedical Informatics (SNUBI), Seoul 110-799, Republic of Korea.
authors.forename: Yu Rang
authors.initials: YR
authors.lastname: Park
authors.forename: Ju Han
authors.initials: JH
authors.lastname: Kim
mesh_terms: D002986:Clinical Trials as Topic; D003628:Database Management Systems; D006801:Humans; D007256:Information Systems / Q000592:standards*; D009369:Neoplasms; D012042:Registries / Q000592:standards*