综合干预提升监查员在我院临床试验机构履职的效果

王婷; 万星驿; 张志华; 王方杰; 罗芳梅

doi:10.13407/j.cnki.jpp.1672-108X.2021.01.016

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综合干预提升监查员在我院临床试验机构履职的效果

临床（药事）管理与规范 | 更新时间：2022-11-03

- 综合干预提升监查员在我院临床试验机构履职的效果
- Effects of Comprehensive Intervention in Improving the Performance of Clinical Research Associate in the Drug Clinical Trial Institutions
- 儿科药学杂志 2021年27卷第1期页码：52-55
- 作者机构：
  
  湖南省儿童医院,湖南,长沙,410007
- 作者简介：
- 基金信息：
  
  基金项目:湖南省儿童医院2017年度院级科研课题,湘儿医行[2017]66 号。
- DOI：10.13407/j.cnki.jpp.1672-108X.2021.01.016
  中图分类号：
- 纸质出版日期：2021，
  
  网络出版日期：2021-1-10，
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王婷, 万星驿, 张志华, 等. 综合干预提升监查员在我院临床试验机构履职的效果[J]. 儿科药学杂志, 2021,27(1):52-55.

Wang Ting, Wan Xingyi, Zhang Zhihua, et al. Effects of Comprehensive Intervention in Improving the Performance of Clinical Research Associate in the Drug Clinical Trial Institutions[J]. 2021,27(1):52-55.
王婷, 万星驿, 张志华, 等. 综合干预提升监查员在我院临床试验机构履职的效果[J]. 儿科药学杂志, 2021,27(1):52-55. DOI： 10.13407/j.cnki.jpp.1672-108X.2021.01.016.

Wang Ting, Wan Xingyi, Zhang Zhihua, et al. Effects of Comprehensive Intervention in Improving the Performance of Clinical Research Associate in the Drug Clinical Trial Institutions[J]. 2021,27(1):52-55. DOI： 10.13407/j.cnki.jpp.1672-108X.2021.01.016.

摘要

目的：通过综合干预促促进监查员（CRA）在我院临床试验机构有效履职。方法：2017年8-11月对CRA在我院临床试验机构履职情况进行问卷调查，分析CRA履职薄弱环节并制定综合干预措施；2017年12月至2018年11月实施综合干预措施；2018年12月至2019年3月对干预后CRA在我院临床试验机构履职情况进行再次问卷调查。以CRA履职情况的综合评分为衡量标准，比较干预前后CRA在我院临床试验机构履职的情况，以确认干预措施的有效性。结果：综合干预后，CRA履职薄弱环节综合评分均高于干预前（P均<0.05）。结论：应用综合干预可以显著促进CRA在我院临床试验机构的有效履职。

Abstract

Objective: To improve the performance of clinical research associate (CRA) in the drug clinical trial institutions of our hospital by comprehensive intervention. Methods: Based on the results of questionnaire on the performance of CRA in the drug clinical trial institutions of our hospital from Aug. to Nov. 2017

the weak links in the performance of CRA were analyzed

and interventions were developed. Comprehensive interventions were performed from Dec. 2017 to Nov. 2018. From Dec. 2018 to Mar. 2019

another questionnaire survey was conducted on performance of CRA in the drug clinical trial institutions of our hospital after intervention. In order to confirm the effectiveness of intervention measures

the performance of CRA in the drug clinical trial institutions of our hospital were compared before and after intervention by taking the comprehensive score of performance of CRA as the measurement standard. Results: After comprehensive intervention

the comprehensive score of weak links in performance of CRA was higher than that before intervention (P<0.05). Conclusion: The application of comprehensive intervention can significantly improve the performance of CRA in the drug clinical trial institutions of our hospital.

关键词

综合干预监查员履职管理

Keywords

comprehensive interventionclinical research associateperformancemanagement

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