多学科协作在药物Ⅰ期/BE临床试验中受试者风险管理的应用研究进展

Application of multidisciplinary collaboration to subject risk management in phase I/BE clinical trials

研究临床试验中各职责方通过多学科协作的方式进行合作,提高受试者管理中风险识别的水平,通过人为干预、受试者风险管理、科学化的决策来制定相关管理措施、互联网络信息化管理等措施,在每一次药物Ⅰ期/BE临床试验中最大限度地保障受试者的安全、减少不良事件发生、确保临床试验的顺利实施,提高各方在临床试验过程中受试者管理的风险责任意识,提升医院的药物临床试验的质量管理能力和发展。

In clinical trials,all responsible parties cooperate in a multidisciplinary way to improve the level of risk identification in subject management.Through human intervention,subject risk management,scientific decision-making,relevant management measures,internet information management and other measures are formulated.In each phase I/BE clinical trial,we will maximize the safety of the subjects,reduce the occurrence of adverse events,ensure the smooth implementation of the clinical trial,improve the risk responsibility consciousness of the subjects management of all parties in the clinical trial process,and enhance the quality management ability and development of the hospital’s drug clinical trial.