title: Interconnection of electronic medical record with clinical data management system by CDISC ODM.
abstract: EDC system has been used in the field of clinical research. The current EDC system does not connect with electronic medical record system (EMR), thus a medical staff has to transcribe the data in EMR to EDC system manually. This redundant process causes not only inefficiency but also human error. We developed an EDC system cooperating with EMR, in which the data required for a clinical research form (CRF) is transcribed automatically from EMR to electronic CRF (eCRF) and is sent via network. We call this system as "eCRF reporter". The interface module of eCRF reporter can retrieves the data in EMR database including patient biography data, laboratory test data, prescription data and data entered by template in progress notes. The eCRF reporter also enables users to enter data directly to eCRF. The eCRF reporter generates CDISC ODM file and PDF which is a translated form of Clinical data in ODM. After storing eCRF in EMR, it is transferred via VPN to a clinical data management system (CDMS) which can receive the eCRF files and parse ODM. We started some clinical research by using this system. This system is expected to promote clinical research efficiency and strictness.
authors.affiliation: Medical Informatics, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Matsumura
authors.affiliation: MKS ltd, Osaka, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Hattori
authors.affiliation: Medical Informatics, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Shiro
authors.initials: S
authors.lastname: Manabe
authors.affiliation: Medical Informatics, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Takeda
authors.affiliation: MKS ltd, Osaka, Japan.
authors.forename: Daiyo
authors.initials: D
authors.lastname: Takahashi
authors.affiliation: Medical Informatics, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Yamamoto
authors.affiliation: Division of Medical Informatics, Osaka University Hospital, Osaka, Japan.
authors.forename: Taizo
authors.initials: T
authors.lastname: Murata
authors.affiliation: Medical Informatics, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Mihara
mesh_terms: D057286:Electronic Health Records / Q000458:organization & administration*; D005568:Forms and Records Control; D016247:Information Storage and Retrieval / Q000379:methods*; D008331:Management Information Systems; D008498:Medical Record Linkage / Q000379:methods*; D009323:Natural Language Processing; D018511:Systems Integration; D014584:User-Computer Interface