%0 Journal Article %T 临床监查员绩效评估痛点及对策研究
Study on the Pain Points and Countermeasures of CRA Performance Evaluation %A 陆佳婕 %J Modern Management %P 3174-3180 %@ 2160-732X %D 2024 %I Hans Publishing %R 10.12677/mm.2024.1412382 %X 在临床试验领域，临床监查员(Clinical Research Associate, CRA)扮演着至关重要的角色，肩负着确保临床试验的合规性、数据的准确性和受试者的安全及权益的重任。临床监查员需要负责监查和评估临床试验研究中心所开展的各项临床活动，包括试验方案、标准操作规程和试验用医疗器械或药物等情况。然而，对临床监查员的工作进行绩效评估并非易事。本文深入探讨了临床监查员绩效评估中的主要痛点，并提出了相应的解决对策。在评估的痛点方面，文章指出评估指标难以量化、评估方法主观性强、评估结果反馈不及时、监查员变更频繁、工作环境的不确定性以及不同临床中心带来的评估困难等问题。这些痛点严重影响了临床监查员绩效评估的准确性和有效性。针对这些挑战，本文提出了一系列对策。首先，建议优化目标设定原则，确保评估指标既有挑战性又可实现。其次，采用多元化的评估方法，结合定量和定性评估，以减少主观性并提高评估的全面性。第三，建立实时反馈机制，确保评估结果的及时传递和问题的解决。最后，提出降低监查员流动率的措施。通过这些对策，可以有效提升临床监查员绩效评估的质量，进而促进临床研究的顺利进行并提高临床监查员的工作效率和工作质量。
In the field of clinical trials, Clinical Research Associate (CRA) plays a crucial role, with the responsibility of ensuring the compliance of clinical trials, the accuracy of data, and the safety and rights of subjects. CRA is responsible for monitoring and evaluating the clinical activities carried out by the clinical trial research site, including the trial protocol, standard operating procedures, and experimental medical devices or drugs. However, evaluating the performance of CRA is not an easy task. This article delves into the main pain points in the performance evaluation of CRAs and proposes corresponding solutions. In terms of the pain points in evaluation, the article identifies issues such as the difficulty in quantifying evaluation indicators, the subjectivity of evaluation methods, the delayed feedback of evaluation results, the frequent changes in CRA, the uncertainty in the work environment, and the challenges in evaluation brought by different clinical sites. These pain points severely affect the accuracy and effectiveness of CRA performance evaluations. Addressing these challenges, the article puts forward a series of countermeasures. Firstly, it suggests optimizing the principles of goal-setting to ensure that evaluation indicators are both challenging and achievable. Secondly, it advocates for the adoption of diverse evaluation methods, combining quantitative and qualitative assessments, to reduce subjectivity and enhance the comprehensiveness of the evaluation. Thirdly, it proposes establishing a real-time feedback mechanism to ensure timely communication of evaluation results and the resolution of issues. Finally, it proposes measures to reduce the turnover rate of CRA. Through these countermeasures, the quality of CRA performance evaluations can be effectively enhanced, thereby promoting the smooth progress of clinical research and improving the work efficiency and quality of CRA. %K 临床试验， %K 监查员， %K 绩效评估， %K 关键绩效指标
Clinical Trials %K CRA %K Performance Evaluation %K Key Performance Indicator %U http://www.hanspub.org/journal/PaperInformation.aspx?PaperID=103611