Investigation and analysis of clinical trial research nurse to perform standard operating procedures

Yan Lin , Yan-Yun Wu , Mei-Hua Wu , Xiu-Yu Yang , Ming Zhou
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引用次数: 2

Abstract

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.

临床试验调查分析研究护士执行标准操作程序
目的探讨临床试验过程中护士不遵守标准操作程序的情况及影响因素。方法将5例参加临床试验的患者分为sop前培训组和sop后培训组,比较观察临床试验过程中存在的问题及护士是否遵循了sop。分析了产生问题的原因,并提出了纠正措施。结果培训后,对sop的符合性有明显提高。训练后出现3例异常行为,而训练前出现21例异常行为。结论护士严格执行临床操作规程,可提高临床试验质量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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