Research on Clinical Research Informatics Related Standards to Achieve the Secondary Use of Healthcare Data

• Main Authors: Hsing-Tzu Wu, 吳幸姿
• Other Authors: Der-Ming Liou
• Format: Others
• Language: en_US
• Published: 2011
• Online Access: http://ndltd.ncl.edu.tw/handle/26152261196599487538

碩士 === 國立陽明大學 === 生物醫學資訊研究所 === 99 === Clinical researchers need a great deal of subjects’ data to conduct a clinical study. The costs would be enormous if every study developed its own mechanisms for collecting data, and it’ll also produce redundant data. Currently, a vast amount of healthcare data is produced and recorded in the Hospital Information System (HIS) during routine patients’ healthcare process. If the healthcare data could be retrieved from HIS, via standard format and process to put into Clinical Research Data Management System (CDMS), the data would be usable for clinical research. The approach adopted consists of creating a CDISC-led Clinical Data Acquisition Standards Harmonization (CDASH)-based database, transferring the de-identified healthcare data from HIS to the database, followed by pre-populating the CDASH-based eCRFs (electronic Case Report Forms) in an actual CDMS. Researchers in clinical research group could see the eCRFs with pre-populated data eventually. Thus, this study would achieve the secondary use of healthcare data and accelerate the process of clinical research.