[Objective] This study explores new ways to integrate multi-source clinical research data based on CDISC standard. [Context] The proposed method simplifies the procedures of submitting research data to the drug regulatory department and speeds up the listing of new drugs. It also promotes the sharing of data from different studies. [Methods] First, we designed a CRF based on the CDISC CDASH standard. Then, we mapped the electronic medical records to the CRF in accordance with the ODM standard. Third, we integrated the medical records with the clinical experimental data in the EDC system. Finally, all data were stored in the standard SDTM format database. [Results] We successfully integrated data from different systems into a CDISC database. [Conclusions] The proposed method effectively integrates electronic medical records and clinical experimental data. It helps us avoid entering duplicated data and improves the efficiency of clinical research.
齐惠颖, 郭建光. 基于CDISC标准的多源临床研究数据整合关键技术与实现*[J]. 数据分析与知识发现, 2018, 2(5): 88-93.
Qi Huiying,Guo Jianguang. Integrating Multi-Source Clinical Research Data Based on CDISC Standard. Data Analysis and Knowledge Discovery, 2018, 2(5): 88-93.
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