Development of case report form based on clinical data interchange standards consortium on special diseases to promote the ecology construction of real-world data in China
10.3760/cma.j.cn112338-20210629-00505
- VernacularTitle:开发专病临床数据交换标准协会病例报告表助力我国真实世界数据生态建设
- Author:
Xiaoxia PENG
1
;
Jian SU
;
Siyu CAI
;
Ruiling PENG
;
Yaguang PENG
;
Xiaoli MA
;
Xin NI
Author Information
1. 国家儿童医学中心，首都医科大学附属北京儿童医院，临床流行病与循证医学中心，北京 100045
- Keywords:
Real world data;
Clinical data interchange standards consortium;
Clinical report form
- From:
Chinese Journal of Epidemiology
2021;42(12):2201-2207
- CountryChina
- Language:Chinese
-
Abstract:
Real world data (RWD) refers to the data generated in routine clinical practices, daily life, and real work environment and has been widely used in clinical or public health research. Still, issues related to the quality of RWD, such as incompleteness, inconsistency, and inaccuracy, would affect the validity of real-world research. To overcome the challenges due to the lack of standardization of real world source data, case report form based on clinical data interchange standards consortium (CDISC-CRF) on certain diseases was developed to promote the ecology construction of RWD based on the data standards set by the CDISC which has been widely used. Firstly, we described how to apply data standards to make up the gap between RWD and real world evidence. Then, the process was designed to build RWD ecology based on CDISC-CRF, in which the development technology of CDISC-CRF form is mainly introduced. Finally, the application prospect and significance of building real-world data based on disease-specific CDISC-CRF are described. It is believed that the present paper can provide a new idea for promoting the ecology construction of RWD in China.
