Objective To identify the nursing quality issues and management nodes involved in phase Ⅰ clinical trial and construct a nursing quality management index system based on the ISO 9001 standard.Methods The index system was determined through literature review,brainstorming,expert consultation,etc.,and the initial application was carried out from November 2023 to January 2024.Results A phase Ⅰ clinical trial nursing quality management in-dex system with 8 primary indicators and 54 secondary indicators was established.After the application,the standardiza-tion of the use of instruments and equipment,the standardization of data entry and the compliance of protocol implemen-tation in Phase Ⅰ clinical trial were improved.Conclusion The Phase Ⅰ clinical trial nursing quality management index system based on ISO 9001 standard is scientific and practical,and can be used for clinical trial nursing quality manage-ment.
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