Yan Lin , Yan-Yun Wu , Mei-Hua Wu , Xiu-Yu Yang , Ming Zhou
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Investigation and analysis of clinical trial research nurse to perform standard operating procedures
Objective
The aim of this study was to investigate the situations and factors that cause nurses not to follow standard operating procedures (SOPs) during the clinical trial process.
Methods
Five cases involving patients enrolled in a clinical trial were divided into two groups, pre-SOP training and post-SOP training, to compare and observe the process problems and whether nurses followed SOPs in clinical trials. The causes of problems were analyzed and corrective measures were proposed.
Results
Our results indicate significant improvement in compliance with SOPs after training. There were three occurrences of irregular behavior after training compared with 21 occurrences of irregular behavior before training.
Conclusions
The quality of clinical trials can be improved if nurses strictly follow SOPs.
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