本文就如何加强对伦理审查委员会档案材料的管理,提高档案管理人员对伦理委员会档案材料管理工作重要性的认识,提高临床药理试验伦理审查工作档案管理的规范性提供提供意见和建议。 This article provides suggestions and suggestions on how to strengthen the management of archives materials of ethical review committee, raise the awareness of archivists on the importance of ethics committee archives material management, and improve the normativeness of archives management of clinical pharmacology ethics review.