Measurement tools and rationality evaluation of clinical research coordinator's work ability and workload / 中国临床药理学与治疗学

ABSTRACT

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 (CRCPA-AT) 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.