The Study of Standard-based Electronic Case Report Form Design System

• Main Authors: Chun-Chiao Huang, 黃俊喬
• Other Authors: Der-Ming Liou
• Format: Others
• Language: zh-TW
• Online Access: http://ndltd.ncl.edu.tw/handle/6ynvw2

碩士 === 國立陽明大學 === 生物醫學資訊研究所 === 97 === With the growth of electronic health records (EHR) and increasing use of electronic data capture (EDC) system, the reuse of patient care data is becoming possible. However, integrating patient care with clinical research to facilitate clinical trial data collection still remains a great challenge. Due to the lack of interoperability between EHR systems and clinical data management systems (CDMS), an investigational site conducting several clinical trials may have to either use customized EDC systems or manually re-enter clinical data by researchers for each clinical trial. Inefficiencies in clinical trial data collection may cause delays and poor data quality, increase costs, and may even harm patients due to the inability to identify potential risks thus significantly impacting the clinical research. To support interoperability, this study implemented an electronic case report form (eCRF) design system based on CDISC Clinical Data Acquisition Standards Harmonization (CDASH). The objective of this system is to facilitate the design of standard-based electronic case report form and minimize the need of customization for EDC system by providing build-in standardized case report form template.