Yang Yu, Zhang Guandong, Zhao Ruiling. Investigation on Current Status of Quality Management in 14 Pediatric Clinical Trial Institutions in China[J]. 2022,28(5):21-24.
Yang Yu, Zhang Guandong, Zhao Ruiling. Investigation on Current Status of Quality Management in 14 Pediatric Clinical Trial Institutions in China[J]. 2022,28(5):21-24. DOI: 10.13407/j.cnki.jpp.1672-108X.2022.05.006.
Objective: To investigate the quality management of pediatric clinical trial institutions
so as to provide optimization suggestions for further improving the quality of pediatric clinical trials. Methods: Questionnaire survey was performed on 14 pediatric clinical trial institutions in the pediatric clinical trial collaboration network in China
and the results were exported to Excel 2016 for statistics. The quality management mode
allocation of clinical trial quality management personnel
content of quality control and development of quality control standards of each institution were analyzed. Results: A total of 14 questionnaires were distributed
14 valid questionnaires were recovered
and the effective recovery rate was 100%. All of the 14 clinical trial institutions surveyed were all able to perform the corresponding responsibilities in quality management
but there were still areas that need to be strengthened. Conclusions: For quality management of pediatric clinical trials
scientific quality management methods should be actively applied
proper staffing and quality control in institutional offices should be improved. Meanwhile
unified quality control standards should be established within the scope of pediatric clinical trial collaboration network. All of these measures will be conducived to further improvement of project quality.