摘要
供应商合规管理在远程智能临床试验或去中心化临床试验(DCT)的质量管理中扮演着至关重要的角色。DCT模式倡导“以患者为中心”,通过远程智能技术创新传统临床试验流程,如受试者招募、知情同意和远程访视等,这些环节均需供应商的深入参与。在众多供应商参与的复杂环境中,申办者必须确保试验的规范性、数据的真实性及受试者权益和安全。本文深入剖析了建立健全的DCT供应商合规管理生态体系的必要性,分析了当前面临的主要问题,提出了完善管理与评估的措施,并建议强化法律法规体系、政府监管和行业自律建设,以构建稳固的合规管理基础。本文还对DCT供应商合规风险以及未完善的行业合规生态进行了分析,建议采取一系列措施以确保整个生态体系的合规与和谐,并强调了生态建设对于维护高标准临床试验质量的重要性。
Decentralized clinical trials(DCT)adopt a patient-centered approach,utilizing smart technology in key processes like recruitment,informed consent,and remote monitoring.This method significantly involves vendors.Effective vendor compliance management in these complex trials is essential for maintaining strict protocol adherence,data integrity,and participant safety.This article explores the critical role of a strong DCT vendor compliance management ecosystem.It identifies current challenges and suggests strategies to improve management and assessment methods.The need for enhanced legal frameworks,regulatory oversight,and industry self-regulation to establish a firm compliance base is also stressed.Moreover,the article provides a detailed analysis of DCT vendor compliance risks and the prevailing gaps in industry compliance.It advocates for a comprehensive set of measures to ensure ecosystem compliance and cohesion,emphasizing the importance of ecosystem development in upholding high clinical trial standards.
作者
葛永彬
董剑平
邵亚光
GE Yong-bin;DONG Jian-ping;SHAO Ya-guang(Zhong Lun Law Firm)
出处
《中国食品药品监管》
2023年第12期188-195,共8页
China Food & Drug Administration Magazine
关键词
去中心化临床试验
合规管理
供应商
注册核查
检查
decentralized clinical trials
compliance management
vendor
regulatory review
inspection
作者简介
第一作者/通讯作者:葛永彬,加州大学伯克利分校(UC Berkeley)法学硕士、南京大学法学硕士、中国人民大学经济学硕士,北京市中伦(上海)律师事务所,资深合伙人。专业方向:医药健康与生命科学。
