Problems and Analysis of In-hospital Audits Based on Clinical Trial Projects
10.3870/j.issn.1004-0781.2024.10.015
- VernacularTitle:临床试验项目院内稽查存在的问题及分析
- Author:
Xilan ZHAO
1
;
Lihua JIA
;
Li WANG
Author Information
1. 北京大学国际医院药剂科,北京 102206
- Keywords:
Clinical pharmacists;
Drug clinical trials;
Audit;
Quality management
- From:
Herald of Medicine
2024;43(10):1625-1631
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish an audit team at the Clinical Trial Institution and explore the feasibility of a new model involving clinical pharmacists in auditing clinical trial projects in hospitals.Methods The audit team consists of 6 clinical pharmacists trained as clinical trial auditors by the National Medical Products Administration Institute of Executive Development and specialized coaching by experts from other hospitals.Results The audit team completed a total of 16 audit reports and identified 189 problems,including 128 general problems,58 important problems and 3 serious problems.The institution,sponsors,investigators and subjects were all involved.Conclusion Based on the actual situation of our hospital,the mode of clinical pharmacists establishing audit teams in medical institutions can effectively improve the quality management level of drug clinical trial projects.
