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Data Analysis and Knowledge Discovery  2018, Vol. 2 Issue (5): 88-93    DOI: 10.11925/infotech.2096-3467.2017.1321
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Integrating Multi-Source Clinical Research Data Based on CDISC Standard
Huiying Qi(),Jianguang Guo
School of Foundational Education, Peking University Health Science Center, Beijing 100191, China
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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.

Key wordsCDISC      Data Integration      EDC      CRF      CDASH     
Received: 26 December 2017      Published: 20 June 2018

Cite this article:

Huiying Qi,Jianguang Guo. Integrating Multi-Source Clinical Research Data Based on CDISC Standard. Data Analysis and Knowledge Discovery, 2018, 2(5): 88-93.

URL:

http://manu44.magtech.com.cn/Jwk_infotech_wk3/EN/10.11925/infotech.2096-3467.2017.1321     OR     http://manu44.magtech.com.cn/Jwk_infotech_wk3/EN/Y2018/V2/I5/88

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