Historically, it has been labor intensive for RPCI researchers to obtain accurate clinical data from multiple disparate sources in a HIPAA compliant manner. To improve efficiency, RPCI established the Clinical Data Network (CDN) Shared Resource, an operational network of people, databases and IT tools working together to consistently collect, abstract, retrieve, integrate, process, link to bio-specimens, and deliver clinical data in a cost-effective manner. It is the meaningful integration of people, research infrastructures and processes, and Information Technology (IT) resources that makes CDN a unique, nimble and effective shared resource. In fact, thanks to the CDN, researchers at RPCI today can get reliable clinical data in three to six days rather than the three to six weeks required before: In the two years of its existence, the CDN has been successfully developed into a shared resource, and seamlessly integrated into the RPCI translational research process. It is already being successfully used by an increasing number of CCSG peer reviewed members with high user satisfaction. The CDN is led by Carmelo Gaudioso, MD, MBA, PhD, Director of Biomedical Informatics. The CDN provides specialized data management technologies, services, and expertise to CCSG members conducting non-interventional research. It guides investigators through the protocol development process, including regulatory and data requirements, and facilitates the review and approval by Disease Site Research Groups (DSRGs) for their use of bio-specimens and data. It provides Honest Broker (HB) service for the delivery of de-identified data and the re-identification for the subsequent delivery of foliow-up data in a HIPAA compliant manner. To establish interoperability across the disparate databases and facilitate data integration and sharing, the CDN facilitates the creation and adoption of standard data dictionaries and data standards. The CDN collaborates with other Shared Resources, notably the Pathology Resource Network (PRN) and the Data Bank and BioRepository (DBBR), for the annotation and the selection of bio-specimens based on clinical-pathological characteristics. To improve the value of the services provided to CCSG members. Dr. Gaudioso and his staff work closely with the scientific programs to better understand their research and related data requirements. First priority for use is given to peer-review-funded RPCI CCSG members;second priority to non-peer-review- funded CCSG members;third priority to non-members and academic collaborators;and last priority to external users. During the reporting period, the Clinical Data Network Shared Resource has served 28 members from 6 research programs, with 37% utilization by CCSG members with peer reviewed funding. The CCSG support provides 6% of the overall proposed budget.
The CDN provides cost-effective abstraction, retrieval, integration, processing and delivery of accurate and reliable HIPAA-compliant clinical data, with linkages to bio-specimens. This is critical for translational research, and overcomes historical obstacles to cross-platform information integration.
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