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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
Qi Huiying(), Guo Jianguang
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
ZTFLH:  G350  

Cite this article:

Qi Huiying,Guo Jianguang. 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

标准名称 英文名称 简称 功能
研究数据表格模型 Study Data Tabulation Model SDTM 包括全部CDISC模型/标准所涉及的标准词汇和编码集
临床数据采集标准 Clinical Data Acquisition Standards
Harmonization
CDASH 用于病例报告表中基础数据收集字段的内容标准
操作数据模型 Operational Data Model ODM 基于XML, 用于获取、交换、报告或递交以及对基于病例报告表的临床研究数据归档的内容和格式标准
CDISC术语词典 用于解释与临床研究信息电子获取、交换、报告相关的术语及其定义
收集数据 CDASH变量名 SDTM变量 说明
不良事件编号 aespid AESPID 记录受试者每个不良事件的唯一标识符。
不良事件名称 aeterm AETERM 不良事件的名称。
不良事件开始日期 aestdat AESTDTC 不良事件开始时间。
不良事件结束日期 aeendat AEENDTC 不良事件被解决的时间。
不良事件的严重程度 aesev AESEV 描述不良事件的严重程度。
不良事件是否与先天性异常或
出生缺陷有关?
aescong AESCONG 记录“严重”不良事件是否与先天性异常或出生缺陷有关。
不良事件是否与研究治疗有关? aerel AEREL 临床医生/研究者判断研究治疗与不良事件之间是否存在因果
关系。
不良事件的结局? aeout AEOUT 描述与不良事件相关的受试者的状况。
字段名 字段类型 字段说明
ID 自动编号 主键字段
TableName Varchar(20) 电子病历数据库中表名
FormDef Varchar(20) 电子病历数据库中表对应的CRF
Name Varchar(20) 电子病历数据库表中字段名对应CRF一个条目
ItemDef Varchar(20) CRF中的一个条目的ID号
DataType Varchar(20) CRF中的一个条目的数据类型
Length Varchar(20) CRF中的一个条目的长度
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