浅析Ⅰ期药物临床试验仪器设备管理的措施

Brief analysis on the measures for the management of instruments and equipment in phaseⅠdrug clinical trials

目的:通过对机构药物临床试验仪器设备管理工作的现状分析,探讨规范化药物临床试验仪器设备管理的各项措施。方法:通过文献检索并结合自身实际工作经验,分析目前仪器设备管理存在的问题,从而建立完善的仪器设备管理制度,细化仪器设备使用标准操作规程,推进大数据模式下的管理方法,加强专业管理队伍的建设。结果:实施仪器设备的专人管理能够保障仪器设备管理工作的全面落实,降低仪器设备管理问题的发生频率,提高仪器设备管理人员的专业水平。结论:规范化仪器设备管理体系是药物临床试验开展的前提,这有助于提高药物临床试验的准确性和可靠性,有效保证药物临床试验的质量,为后续临床试验打下坚实基础。

AIM:To discuss the standardized management methods of drug clinical trial instruments and equipment based on the analysis of current situation of the management in drug clinical trial instruments and equipment in institutions.METHODS:Through literature searching and our experience,we analyzed the nowadays problems in management of instruments and equipment,established and improved the management system,refined the standard operating procedures,promoted information management,and strengthened the construction of professional team of instrument and equipment management or database.RESULTS:The implementation of dedicated management ensured the whole implementation management,reduced the frequency in management problems,and improved the professional level of instrument and equipment management.CONCLUSION:The construction of standardized instrument and equipment management system is the premise of standardized development of drug clinical trials,which improves the management level of drug clinical trial instruments and equipment,ensures the authenticity and accuracy of trial data,and effectively enhances the quality of following drug clinical trials.