Kim Yunjeong, Lee Heeyoung
Center for Advanced Clinical Trial Education, Inje University, Gimhae, Gyeongnam, Republic of Korea.
Inje Institute of Pharmaceutical Sciences and Research, Inje University, Gimhae, Gyeongnam, Republic of Korea.
Trials. 2025 Mar 21;26(1):100. doi: 10.1186/s13063-025-08795-w.
Clinical audits are essential to ensure that clinical research processes align with regulatory standards and best practices. Despite this, there has been no error assessment of the relationship between the errors in investigational medicinal product (IMP) management and clinical trial workers with audit experience.
This study surveyed stakeholders with experience being audited to evaluate errors in IMP management and accountability during clinical trials through online survey system. The survey focused on errors in IMP export, dosing, storage, shipping, and labeling. Errors related to IMP management or accountability were evaluated with 22 specific criteria. Analysis included descriptive statistics and Pearson's correlation.
A total of 41 participants experiencing audits in clinical trial were enrolled in the current survey. The survey results revealed that the most frequent errors occurred in missing essential documents for shipment during IMP shipping and errors in label information, each accounting for 24 cases (58%). Additionally, a significant correlation was found between participants' age, work experience, and audit experience (coefficient = 0.77, p value < 0.05).
A survey of individuals with auditing experience identified common errors in IMP management, particularly missing shipment documents and incorrect labeling. To address these issues, clinical trial systems should implement regular error monitoring, standardized procedures, and comprehensive staff training to ensure safer and more efficient trials.
临床审计对于确保临床研究过程符合监管标准和最佳实践至关重要。尽管如此，对于研究用药品（IMP）管理中的错误与具有审计经验的临床试验工作人员之间的关系，尚未进行错误评估。
本研究通过在线调查系统对有被审计经验的利益相关者进行了调查，以评估临床试验期间IMP管理和责任方面的错误。该调查聚焦于IMP出口、给药、储存、运输和标签方面的错误。使用22条具体标准对与IMP管理或责任相关的错误进行评估。分析包括描述性统计和Pearson相关性分析。
共有41名经历过临床试验审计的参与者参与了本次调查。调查结果显示，最常见的错误发生在IMP运输过程中缺少装运必需文件以及标签信息错误，各占24例（58%）。此外，参与者的年龄、工作经验和审计经验之间存在显著相关性（系数 = 0.77，p值 < 0.05）。
对具有审计经验的人员进行的一项调查确定了IMP管理中的常见错误，尤其是缺少装运文件和标签错误。为解决这些问题，临床试验系统应实施定期错误监测、标准化程序和全面的员工培训，以确保试验更安全、更高效。
