Ⅰ期临床试验中文档的管理及质量保证

Documents management and quality assurance in phaseⅠclinical trial

本文通过归纳人用药品注册技术要求国际协调会(ICH)-药物临床试验质量管理规范(GCP)中文档管理的要求、试验中文档管理的基本要素、信息化趋势下的电子文档管理与规范以及文档管理的质量保证这4方面进行叙述,探讨了如何在Ⅰ期临床试验中有序地进行文档管理以保证文档的完整及安全。文档管理是保证临床试验资料可溯源临床试验的重要依据,必须有序管理,保质保量。

This article summarizes the document management requirements in international conference on harmonization(ICH)-good clinical practice(GCP),the basic elements of document management in the experiment,the electronic document management and specification under the information trend,and the quality assurance of document management.It discusses how to manage documents in an orderly manner in phaseⅠclinical trial to ensure the integrity and safety of documents.Document management is an important basis for ensuring the traceability of clinical data to clinical trial.It must be managed in an orderly manner to ensure quality and quantity.