Strategy on Management of Self-inspection

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.

 
1. When to conduct self-inspection?

The purpose of self-inspecon is to meet CFDA’s requirement on subming self-inspection report (to disclose issues during the study) as part of the NDA approval and assure data integrity for the upcoming NDA pre-approval inspection. So we suggest to embed this requirement in routine monitoring /co-monitoring visits for ongoing and new trials, to achieve inspecon readiness at all times: 

• During routine site monitoring: pay sufficient attention to CFDA requirements on source document/ verify subject informaon in HIS and LIS,  subject ID; temperature records during IP ......

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