【摘要】 【目的】探索基于CDISC标准整合多源临床研究数据的方法。【应用背景】基于CDISC整合临床研究数据,简化研究者向药监部门递交数据的程序,加速新药投入市场的过程,同时也有利于不同研究之间数据的共享。【方法】基于CDISC的CDASH数据标准设计CRF,通过ODM标准将电子病历数据映射到CRF中并和临床实验数据统一整合到EDC系统,最终转换为标准SDTM格式的数据库。【结果】将位于不用系统中的临床研究数据统一整合成符合CDISC标准的数据库。【结论】解决电子病历数据和临床实验数据的整合问题,避免数据的重复录入,提高临床研究的效率。更多还原

【Abstract】 [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.更多还原