| 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。 |
| 关键词: 综合干预 监查员 履职 管理 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2021.01.016 |
|
| 基金项目: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。 |
|
| Effects of Comprehensive Intervention in Improving the Performance of Clinical Research Associate in the Drug Clinical Trial Institutions |
| Wang Ting, Wan Xingyi, Zhang Zhihua, Wang Fangjie, Luo Fangmei |
| (Hunan Children’s Hospital, Hunan Changsha 410007, China) |
| 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. |
| Key words: comprehensive intervention clinical research associate performance management |
