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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| Format: | Article |
| Language: | English |
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BMC
2025-03-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-025-08795-w |
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| author | Yunjeong Kim Heeyoung Lee |
| author_facet | Yunjeong Kim Heeyoung Lee |
| author_sort | Yunjeong Kim |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-46973d3473804191b654d450d8266bee |
| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-46973d3473804191b654d450d8266bee2025-08-20T03:41:47ZengBMCTrials1745-62152025-03-012611810.1186/s13063-025-08795-wAudit experiences in investigational medicinal product management and errors in clinical trialsYunjeong Kim0Heeyoung Lee1Center for Advanced Clinical Trial Education, Inje UniversityCenter for Advanced Clinical Trial Education, Inje UniversityAbstract 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.https://doi.org/10.1186/s13063-025-08795-wInvestigational medicinal productClinical trialAuditSurveyClinical trial stakeholders |
| spellingShingle | Yunjeong Kim Heeyoung Lee Audit experiences in investigational medicinal product management and errors in clinical trials Trials Investigational medicinal product Clinical trial Audit Survey Clinical trial stakeholders |
| title | Audit experiences in investigational medicinal product management and errors in clinical trials |
| title_full | Audit experiences in investigational medicinal product management and errors in clinical trials |
| title_fullStr | Audit experiences in investigational medicinal product management and errors in clinical trials |
| title_full_unstemmed | Audit experiences in investigational medicinal product management and errors in clinical trials |
| title_short | Audit experiences in investigational medicinal product management and errors in clinical trials |
| title_sort | audit experiences in investigational medicinal product management and errors in clinical trials |
| topic | Investigational medicinal product Clinical trial Audit Survey Clinical trial stakeholders |
| url | https://doi.org/10.1186/s13063-025-08795-w |
| work_keys_str_mv | AT yunjeongkim auditexperiencesininvestigationalmedicinalproductmanagementanderrorsinclinicaltrials AT heeyounglee auditexperiencesininvestigationalmedicinalproductmanagementanderrorsinclinicaltrials |