A risk-based quality control approach of Clinical Trials from a GCP institution in China

Background This paper developed and described a risk-based quality control approach of clinical trials for clinical trial sites to improve the quality control process and ensure the quality of data. Methods Based on the trial experience, well versed experts and the findings of previous literature, an integrated risk-based quality control approach is developed centered on three cornerstones: risk assessment, central data review, and triggered, adaptive on-the-spot or remote inspection. Results We have developed an innovative risk-based quality control approach for clinical trials including risk assessment, development of quality control plan, implementation of quality control activities, development and review of quality control report, undertake actions arising from quality control report, and the update of risk assessment results or quality control plan, which fuses the idea of PDCA circle and quality by design. Conclusion Our RBQC methodology can significantly improve the clinical quality control process and the monitoring-audit triggered procedure can synchronize the activities of site, sponsor and CROs to achieve all-win. It is an innovative and effective approach.