Monitoring in multicenter clinical trial

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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2004, Vol. 9 ›› Issue (7): 835-837.

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Monitoring in multicenter clinical trial

WANG Wen, MA Li-Yuan, ZOU Xiao-Man¹

Cardiovascular Institute, Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China;
¹General Hospital of PLA, Beijing 100853, China

Received:2004-06-15 Revised:2004-07-05 Online:2004-07-26 Published:2020-11-20

Abstract

Abstract: In order to ensure the multicenter clinical trial quality by carrying out good clinical practice, the monitoring procedures and methods were introduced for the multicenter trial of ADVANCE.We suggest that the monitor should adequate medical and pharmaceutical qualifications and have the clinical trial experience.The monitor should visit each site to review the CRF, study files and data according to the procedures.Good monitoring is assistance to improve the quality of multicenter clinical trial.

Key words: multicenter, clinical trial, quality, Monitoring

CLC Number:

R965.3

WANG Wen, MA Li-Yuan, ZOU Xiao-Man. Monitoring in multicenter clinical trial[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2004, 9(7): 835-837.

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Monitoring in multicenter clinical trial

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