临床研究协调员工作能力与工作量的测量工具及合理性评估

Measurement tools and rationality evaluation of clinical research coordinator's work ability and workload

目的:通过收集临床协调员的工作压力和个人能力值,本文拟建立一种以测量研究协调员工作能力与临床试验项目工作量为核心的项目管理工具,优化医疗机构或临床试验现场管理组织的临床试验项目分配依据。方法:本研究在五大数据库中进行不同检索词的搜索,收集江苏省苏北人民医院评估工作能力与工作量的信息,确定评分表。此外,对协调员的工作压力源特征采用SPSS 26.0版统计软件和稳定系数法进行汇总性分析。结果:本研究建立了临床研究协调员的个人能力评分表(CRCPA-AT)和临床试验项目工作量评分表(CTPW-AT)来评估协调员的工作能力与临床试验的工作量。本研究的两大工具在61名协调员和144个临床试验项目中进行了回顾性测试,39名(66.1%)协调员项目分配较合理,18名(30.5%)协调员处于理论压力的状态,其中12名(20.3%)协调员实际压力大,且与理论压力相匹配。结论:本研究从量化协调员的工作能力和临床试验项目工作量出发,建立了两大评分量表,利用61名协调员及管理项目进行验证,采用Likert5点计分法分析,超过86.4%的协调员实际压力情况与本文提供工具量化的理论压力相一致。

AIM:To establish a project management tool to measure the working ability of research coordinators and the workload of clinical trial projects,and optimize medical institutions or clinical trial site management organization(SMO)allocation basis of clinical trial items by collecting the work stress and personal ability values of clinical coordinators.METHODS:Different words in the five major databases were searched and information on the work capacity and workload in the Subei People's Hospital was collected.In addition,the paper analyzes the characteristics of coordinators working pressure source by SPSS26.0 statistical software and stability coefficient method.RESULTS:The study established the clinical research coordinator's personal ability-assessment tool(CRCPAAT)and clinical trial project workload-assessment tool(CTPW-AT)to assess the coordinator's working ability and clinical trial workload.The two tools in this study were tested retrospectively in 61 coordinators and 144 clinical trials,39(66.1%)coordinators'projects were reasonably allocated,18(30.5%)coordinators were in the state of theoretical pressure and 12(20.3%)coordinators had high actual pressure,which matched with the theoretical pressure.CONCLUSION:In this study,two scoring scales were established to quantify the working ability of the coordinators and the workload of clinical trial projects.Through the verification of the 61 coordinators and its management projects,the Likert5 point scoring method was used to analyze,more than 86.4%of the actual pressure of coordinators was consistent with the theoretical pressure quantified by the tool.