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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2012, Vol. 17 ›› Issue (5): 481-484.

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Problems in the recruitment and management of trial subjects for phase I clinical trials in China

ZHANG Zheng-fu, SHEN Yu-hong, LI Zheng-qi   

  1. Center for Drug Certification, State Food and Drug Administration, Beijing 100061, China
  • Received:2011-11-30 Revised:2012-03-20 Online:2012-05-26 Published:2012-05-28

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Abstract: Recruitment of trial subjects is an important part to affect the quality for phase I clinical trial. This paper reviews many problems in the recruitment and management of trial subjects for phase I clinical trial at present, and explores appropriate measures in order to protect the rights, benefits and safety of trial subjects, improve the level and quality of phase I clinical trials in China.

Key words: Recruitment, Trial subjects, Phase I clinical trial

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