GCP Regulatory Compliance in Decentralized Clinical Trials
Implementing risk-based quality management(RBQM)in decentralized clinical trials(DCT)is crucial.The advent of DCT,leveraging remote intelligent technologies,wearable devices,and artificial intelligence algorithms,has introduced new challenges regarding data authenticity and privacy security.Recent regulations,such as the Personal Information Protection Law and the Data Security Law,have heightened requirements for privacy protection.This article analyzes in depth how regulatory compliance assessment forms an integral part of RBQM in DCTs,aiding in identifying and controlling key risks to ensure trial quality and subject safety.The assessment process encompasses risk identification,quantification,control measure formulation,and continuous iteration and optimization.Through regulatory compliance assessment,research institutions can streamline their processes,establish comprehensive quality management systems,safeguard subject rights,and ensure data authenticity,integrity,and traceability.This approach can also enhance researcher engagement,improve data quality,and reinforce Good Clinical Practice(GCP)compliance awareness among vendors.Furthermore,this article explores the insights gained from risk assessments in Good Manufacturing Practice(GMP),Good Supply Practice(GSP),and Privacy Impact Assessment(PIA)systems in personal information protection to regulatory compliance assessment in clinical trials.It also elucidates the positive role of regulatory compliance assessment in aligning China's clinical trial quality management systems with international standards.
万方数据
维普
