主要論述《臨床試驗通用稽查標準》起草背景、目的、制定依據(jù)、適用范圍、稽查內(nèi)容與標準、稽查發(fā)現(xiàn)問題分級定義等，以期進一步完善臨床試驗質(zhì)量管理體系，通過臨床試驗通用稽查標準的建立與執(zhí)行，規(guī)范臨床試驗稽查工作，進而促進臨床試驗領域從業(yè)人員工作自律，規(guī)范臨床試驗過程，確保臨床試驗數(shù)據(jù)真實、結果可靠，加速我國臨床試驗研究的國際化進程，提升行業(yè)臨床試驗稽查水平和臨床試驗能力。

The universal standard of clinical trial audit mainly discusses the drafting background, the purpose, the basis of formulation, the scope of application, the content and standard of auditing, and the grading of audit findings, etc.The main purpose of this standard is, by improving the quality management system of clinical trials, to standardize the audit work and clinical trial process, enhance the self-discipline of practitioners, ensure the authenticity and reliability of clinical trial data. This standard will accelerate the internationalization of clinical trial in China, raise the bar of clinical trial audit and improve the capibility of clinical trial in China.

R951