Manager, Clinical Data Management Systems

Yun Lu PortraitDr. Yun Lu is manager of clinical data management systems and is responsi­ble for the overall development efforts of the Clinical Data Management Systems Team at KAI Research, Inc. With more than 15 years of clinical data management experience, she oversees the analysis, design, implementation, testing, documentation, and support for end user applications. She leads the effort to promote metadata-driven clinical data manage­ment service and e-clinical solutions, including data architecture analysis and design, data governance, data mapping across clinical systems, Military Health System Data Repositories, and data warehouses.

Dr. Lu leads the KAI data standards team to provide National Institutes of Health (NIH) National Cancer Institute (NCI) Cancer Data Standards Registry and Repository (caDSR) Common Data Element (CDE) and metadata curation service. The focus includes ISO/IEC 11179, Vocabularies and Metadata, the caDSR curation tool, the CDE Browser, and the Form Builder tool. As the authorized NCI caDSR metadata curator, she registered 310 neurological CDEs and 119 KAI-developed CDEs into NCI caDSR, registered new neurological terms in EVS for CDE registration, and harmonized NIH National Institute of Neurological Disorders and Stroke (NINDS) CDEs with registered caBIG CDE definitions published by NCI and NINDS. 

Dr. Lu works with the KAI CDE Team to convert legacy clinical trial data into the CDISC format for storage in the Pediatric Pharmacology Research Unit data warehouse. She works closely with CDISC and National Cancer Informatics Program staff and team members. Her experience with CDISC, caBIG, legacy data conversion, and the ETL process of CDEs includes her roles as acting member of the CDISC CDASH substream to identify CDEs and as member of the CDISC Terminology Workgroup.

As a systems analyst, Dr. Lu helps to implement the clinical data standardization program, leads clinical data and IT integration, develops processes and documentation, and trains staff. As the principal developer of KAI’s Internet-accessible electronic data capture system, the OpenClinica Enterprise application, she leads study setup, performs eCRF development, edit-checks programming, develops reports to support data management and analysis, and incorporates CDISC SDTM and CDASH standards into the EDC system.

Dr. Lu leads the development of all clinical data capture systems set up by KAI for government and private-sector pharmaceutical studies, including creation of a database and forms from client specifications, form navigation and real-time edits, and programming. She also leads the development of several Web portals and Web applications for clinical research projects.