Audit experiences in investigational medicinal product management and errors in clinical trials
Abstract Background 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...
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| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-03-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-025-08795-w |
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| Summary: | Abstract Background 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. Methods 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. Results 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). Conclusion 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. |
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| ISSN: | 1745-6215 |