| 摘要: |
| 目的：加强我院药物临床试验机构对临床研究协调员（CRC）履职的监管，以提高临床试验质量。方法：在主要研究者（PI）授权CRC职责前，机构对CRC资质进行审核，对CRC进行临床试验方案、药物临床试验质量管理规范、机构标准操作规程及制度等相关知识培训及考核。在PI授权CRC职责后，机构对CRC的工作进行量化管理，对CRC或临床试验现场管理组织（SMO）进行黑白名单管理。结果：我院CRC基本能有效履行职责，有利于提高临床试验质量，但CRC流动性较大，间接增加了机构工作量。结论：我院药物临床试验机构对CRC履职的监管模式具有推广价值，但仍需进一步优化。 |
| 关键词: 临床研究协调员 履职 机构监管模式 |
| DOI：doi:10.13407/j.cnki.jpp.1672.108X.2020.12.016 |
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| 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。 |
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| Supervision Mode of Drug Clinical Trial Institutions on the Performance of the Clinical Research Coordinator |
| Wang Ting, Zhang Zhihua, Luo Fangmei, Wang Fangjie, Liu Sifan |
| ((Hunan Children’s Hospital, Hunan Changsha 410007, China)) |
| Abstract: |
| Objective: To strengthen the supervision of drug clinical trial institution on the performance of the clinical research coordinator (CRC), so as to better control the quality of clinical trials. Methods: Before the responsibilities of CRC were authorized by principal investigator (PI), the qualifications of CRC would be reviewed, and the CRC would be trained and assessed on the relevant knowledge such as the clinical trial protocol, Good Clinical Practice (GCP), the institutional Standard Operating Procedures (SOP) and management system. After the responsibilities of CRC were authorized by PI, the quantitative supervision of CRC work was carried out, and the black and white list management for CRC or site management organization (SMO) were performed. Results: The most of CRC could effectively perform its duties and improve the quality of clinical trials, yet the CRC had the large mobility, which indirectly increased the workload of drug clinical trial institution. Conclusion: The drug clinical trial institution of our hospital has a good promotion and application value for the supervision mode of CRC, yet it still needs to optimize the supervision mode of CRC. |
| Key words: clinical research coordinator performance supervision mode of the institutions |
