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