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 ...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 fol- lowed 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.展开更多
文摘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 fol- lowed 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.
