Research progress on risk-based management in clinical trials

Abstract

Abstract:

With the evolutions of information technology, the application and development of data management and statistical methods, and onsite tasks resolved by remote approaches, human work replaced by computer automation, a new project management model of risk based management gradually evolved out in clinical research industry. Now, twenty years later, ICH issued a new version of the GCP, and the European and American regulators also issued new guidelines for quality management in clinical trials. These policies and regulations will result in great changes in clinical research industry. In the risk based management model of clinical trials, information technology and professional implementation personnel will both play the important roles.

Key words: clinical research, information technology, risk based management, GCP

CLC Number:

R969

XIAO Liang, ZHENG Gaozhe, HUANG Yumin. Research progress on risk-based management in clinical trials[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2017, 22(8): 955-960.

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