The full process operating procedure for the using of multi -center retrospective electronic medical record data
- VernacularTitle:多中心回顾性电子病历数据使用全流程操作规程
- Author:
Xue ZHONG
1
;
Dongfang QIAN
2
;
Zixuan ZHANG
2
;
Siyuan TAN
2
;
Jianfeng LIU
2
;
Xueyan CUI
3
;
Ruifang NIE
4
;
Ting LI
5
;
Qian WANG
6
;
Qi GUO
7
;
Qiushuang LIU
8
;
Yan LIANG
9
;
Lin HUANG
1
;
Lizong LI
1
;
Yufei FENG
1
Author Information
1. Dept. of Pharmacy，Peking University People’s Hospital，Beijing 100044，China
2. Beijing North Medical Health Economic Research Center，Beijing 100021，China
3. Dept. of Pharmacy，Shandong Provincial Qianfoshan Hospital，Jinan 250014，China
4. Dept. of Pharmacy，Shandong Provincial Hospital，Jinan 250021，China
5. Dept. of Pharmacy，Beijing Hospital，Beijing 100730，China
6. Dept. of Pharmacy，Jinan Central Hospital，Jinan 250013，China
7. Dept. of Pharmacy，Yantai Affiliated Hospital of Binzhou Medical University，Shandong Yantai 256699，China
8. Dept. of Pharmacy，The 2nd Affiliated Hospital of Harbin Medical University，Harbin 150086，China
9. Dept. of Pharmacy，Medical Supplies Center of PLA General Hospital，Beijing 100853，China
- Publication Type:Journal Article
- Keywords:
real-world data;
electronic medical record data;
retrospective research;
data curation;
multi-center research
- From:
China Pharmacy
2022;33(19):2314-2320
- CountryChina
- Language:Chinese
-
Abstract:
With the gradual improvement of medical informatization and the vigorous development of medical and health big data，the exploration and practice of real -world research are becoming more and more mature ，and real -world data have become an important source of evidence for post marketing re -evaluation of drugs . As an important high -quality real -world medical data ， electronic medical record data is an indispensable data source for post marketing re -evaluation of drugs . Most of the existing guidelines and norms of real -world research are designed from the perspective of prospective research ，and do not propose specific measures and methods in the implementation of retrospective research ，especially for the operation suggestions on the technical level of using conventionally collected electronic medical record data . In combination with the operational process framework formulated by the existing guidelines and norms ，this paper creatively adds the operating procedures for dataE- validation，data integration ，data verification ，and throughout quality control ，data management and storage of retrospectiveelectronic medical record data ，and describes the data analysis methods and key points involved in carrying out multi -center retrospective real -world research using electronic medical record data ，taking the post marketing safety research of drugs as an example. Finally，the full process operation procedure applicable to the use of multi -center retrospective electronic medical record data is established .
