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Acta Pharmaceutica Sinica
0513-4870
2015 Issue 11
Master documentation and records in the clinical data management
SUN Hua-long;XU Gang;LI Wei;WEI Zhao-hui;DING Li;On Behalf of Clinical Trial Data Management Working Group of China;
..............page:1365-1366
Source data management in clinical researches
HO Effie;YAO Chen;ZHANG Zi-bao;LIU Yu-xiu;On Behave of Clinical Trial Data Management Working Group of China;
..............page:1367-1373
Clinical trial data management and quality metrics system
CHEN Zhao-hua;HUANG Qin;DENG Ya-zhong;ZHANG Yue;XU Yu;YU Hao;LIU Zong-fan;On Behalf of Clinical Trial Data Management Working Group of China;
..............page:1374-1379
Computerized system validation of clinical researches
YAN Charles;CHEN Feng;XIA Jia-lai;ZHENG Qing-shan;LIU Daniel;On Behalf of Clinical Trial Data Management Working Group of China;
..............page:1380-1387
Infrastructure and contents of clinical data management plan
SHEN Tong;XU Lie-dong;FU Hai-jun;LIU Yan;HE Jia;CHEN Ping-yan;SONG Yu-fei;On Behalf of Clinical Trial Data Management Working Group of China;
..............page:1388-1392
Integrated e-clinical solutions in clinical research
YAN Charles;MI Xian-qiang;ZHUANG Yong-long;Shanghai Hengrui Pharmaceutical Co;Ltd.;Shanghai Advanced Research Institute;Chinese Academy of Science;Beijing Bioknow Information Technology Co;Ltd.;
..............page:1393-1395
Med DRA and its applications in statistical analysis of adverse events
LU Meng-jie;LIU Yu-xiu;Nanjing General Hospital of Nanjing Military Region;PLA;
..............page:1396-1401
Prevention and handling of missing data in clinical trials
JIANG Zhi-wei;LI Chan-juan;WANG Ling;XIA Jie-lai;Department of Health Statistics;Fourth Military Medical University;MSD R&D Co.;Ltd.;
..............page:1402-1407
The importance of clinical data management in improvement of drug evaluation
HUANG Qin;WANG Jun;Center for Drug Evaluation;China Food and Drug Administration;
..............page:1408-1409
Documentation archiving in clinical data management
SUN Hua-long;WEI Zhao-hui;Meta Clinical Technology;Hangzhou Tigermed;
..............page:1410-1414
The significance, development and prospects of healthcare data integration in new drug clinical trials
CAI Hong-wei;LI Yan-hong;ZHANG Zi-bao;DENG Ya-zhong;Information Centre;State Key Laboratory of Military Stomatology;School of Stomatology;Fourth Military Medical University;Merck Serono Pharmaceutical Distribution Co.;Ltd.;Pharmaceutical Product Development;Inc.;Covance Pharmaceutical Research and Development Co.Ltd.;
..............page:1415-1419
cdmc kai she ke cheng jiao yu , zhuo li gao xiao ji chu xue ke jian she
liu chuan ; chen chao hua ;
..............page:1419
Relationship of statistics and data management in clinical trials
CHEN Feng;SUN Hua-long;SHEN Tong;YU Hao;School of Public Health;Nanjing Medical University;Meta Clinical Technology;China R&D and Scientific Affaires;Pharmaceutical Company of Johnson-Johnson;
..............page:1420-1424
cdmc kai zhan zhuan jia gong shi yan tao , yin ling shu ju guan li gui fan ying yong
liu chuan ; zuo zuo ; song yu fei ;
..............page:1424
Quality control of statistical analysis in data management of clinical trials
ZHANG Xin-ji;YU Hao;WEI Zhao-hui;HE Jia;Department of Health Statistics;Second Military Medical University;Department of Biostatistics;School of Public Health;Nanjing Medical University;Tigermed Consulting Co.;Ltd.;
..............page:1425-1427
Overview of CDISC standard and implementation in China
WU Victor;BAO Wen-jun;WANG John;PENG Rui-ling;DENG Ya-zhong;ZHANG Zi-bao;PPD Pharmaceutical Development Co.;Ltd.;JMP Life Sciences;SAS Institute Inc.;Johnson & Johnson China Ltd.;Beijing Improve-Quality Tech.Ltd.;Co.;Covance Pharmaceutical Research and Development Co.;Ltd.;PPD Pharmaceutical Development Co.;Ltd.;Shanghai Branch;
..............page:1428-1433
Global views on clinical trials and data quality
LIU Daniel;HAN Xiu-lan;SUN Hua-long;DAI Nan;Beijing Clinical Service Center;Meta Clinical Technology;Ltd.;
..............page:1434-1442
Overview of global clinical data management regulations and standards
LIU Daniel;Beijing Clinical Service Center;
..............page:1443-1451
Key factors in design of case report form
FU Hai-jun;LUO Xiao-xia;Shanghai Cares Bio-Tech Co;LTD.;
..............page:1452-1455
Exploration of visual check approaches in clinical data management
CHEN Jun-chao;LIU Hong-xia;HE Ying-chun;ZHENG Qing-shan;Center for Drug Clinical Research;Shanghai University of Chinese Medicine;
..............page:1456-1460
Comparison of paper and electronic data management in clinical trials
YIN Fang;CHEN Jun-chao;LIU Hong-xia;HE Ying-chun;ZHENG Qing-shan;Center for Drug Clinical Research;Shanghai University of Chinese Medicine;
..............page:1461-1463
Importance of data management with statistical analysis set division
WANG Ling;LI Chan-juan;JIANG Zhi-wei;XIA Jie-lai;Department of Health Statistics;Fourth Military Medical University;MSD R & D Co.;Ltd.;
..............page:1464-1469
cdmc ti gong zhuan ye pei xun , ti sheng lin chuang shu ju guan li shui ping
liu chuan ; ai chun bo ; tao xiao yu ; song yu fei ;
..............page:1469
Quality control of clinical data management based on EDC
LIU Hong-xia;LV Ying-hua;ZHOU Mao-sheng;MENG Qing-heng;CHEN Jun-chao;HE Ying-chun;ZHENG Qing-shan;Center for Drug Clinical Research;Shanghai University of Chinese Medicine;Beijing Bozhiyin Technology Co.Ltd.;
..............page:1470-1473
Process and method for CDISC-based CRF annotation
WANG Hong-wei;DENG Ya-zhong;LIU Daniel;Covance Pharmaceutical R&D Co.;Limited;Beijing Clinical Service Center;
..............page:1474-1479
cdmc kai zhan zhuan ye jiao liu , nong hou lin chuang yan jiu xue shu fen wei
liu chuan ; zuo zuo ; song yu fei ;
..............page:1479
Clinical trial data validation and user acceptance testing
SUN Hua-long;DAI Nan;Meta Clinical Technology;
..............page:1480-1484
Key issues on the clinical trial data management
CHEN Ping-yan;XU Yu;DAI Nan;Department of Biostatistics;Southern Medical University;Beijing Clinical Service Center;Meta Clinical Technology;Ltd.;
..............page:1485-1487
Implementation of performance metrics in clinical trial data management
DENG Ya-zhong;WANG Hong-wei;FU Hai-jun;Covance Pharmaceutical Research and Development Co.;Ltd.;Shanghai CARES Bio-Tech Co.;Ltd.;
..............page:1488-1492
Basic considerations during outsourcing of clinical data management services
SHEN Tong;LIU Yan;QS China of China R & D and Scientific Affaires;Pharmaceutical Company of Johnson & Johnson;
..............page:1493-1497
Data quality in clinical trials: the role of blind review
YU Yong-pei;YAO Chen;Peking University Clinical Research Institute;Peking University First Hospital;
..............page:1498-1501
shu ju guan li zong jie bao gao
shen tong ; xu lie dong ; fu hai jun ; he jia ; chen ping yan ; liu yan ; song yu fei ;
..............page:1502-1512