Study on the Joint Review Mechanism of Multi-regional Clinical Trial

Abstract

Abstract: Objective To explore the establishment of Chinese multi-regional clinical trial (MRCT) joint ethical review mechanism. Methods The laws, regulations, operation and review mode of MRCT joint ethical review mechanism in the United States, Britain and Taiwan were analyzed. Results The ethical review mechanism of MRCT has not yet been established in China. The United States, the United Kingdom and Taiwan have adopted the independent review and joint review mechanism of the Center Ethics Committee and the Regional Ethics Committee to avoid duplication of ethical review. Conclusion The ethical review mechanism of MRCT is international trends, and China should be established the mechanism step by step.

Key words: clinical trial, joint review mechanism, subjects

CLC Number:

WEI Fen-fang, SUN Yu-xin, ZHENG Yong-xia, YANG Yue. Study on the Joint Review Mechanism of Multi-regional Clinical Trial[J]. Chinese Journal of Pharmacovigilance, 2017, 14(8): 470-476.

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