关键词: Ⅰ期药物临床试验, 仪器设备, 管理措施

Abstract: 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.

Key words: phase Ⅰ drug clinical trial, instrument and equipment, management measures