[關(guān)鍵詞]
[摘要]
主要論述《臨床試驗(yàn)通用稽查標(biāo)準(zhǔn)》起草背景、目的、制定依據(jù)、適用范圍、稽查內(nèi)容與標(biāo)準(zhǔn)、稽查發(fā)現(xiàn)問題分級(jí)定義等,以期進(jìn)一步完善臨床試驗(yàn)質(zhì)量管理體系,通過臨床試驗(yàn)通用稽查標(biāo)準(zhǔn)的建立與執(zhí)行,規(guī)范臨床試驗(yàn)稽查工作,進(jìn)而促進(jìn)臨床試驗(yàn)領(lǐng)域從業(yè)人員工作自律,規(guī)范臨床試驗(yàn)過程,確保臨床試驗(yàn)數(shù)據(jù)真實(shí)、結(jié)果可靠,加速我國(guó)臨床試驗(yàn)研究的國(guó)際化進(jìn)程,提升行業(yè)臨床試驗(yàn)稽查水平和臨床試驗(yàn)?zāi)芰Α?/div>
[Key word]
[Abstract]
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.
[中圖分類號(hào)]
R951
[基金項(xiàng)目]