《GCP稽查国际指南》2014年4月版本是SQA、BARQA以及JSQA在国际性讨论的基础上完成的。其包括申办者稽查部门的使命和组织架构，稽查计划的制定、执行和报告的原则。该指南不仅对于申办者的稽查员提供最优的操作指南（Best Practice），而且对....... ...

During the recent China QA Forum Face-to-Face meeng on 25 May, a workshop was organized to discuss how to manage self-inspecon in China in reflecon of CFDA self-inspecon requirements issued on 22 Jul 2015. Below is the summary of the discussion: Note: Self-inspecon in this arcle refers to sponsor’s acvies to idenfy and report issues occurred in the study to CFDA via subming the self-inspecon report for studies that have been submied to CFDA but pending for the agency’s approval. ...