earticle

영어

To ensure the reliability of research data in clinical trials, this study analyzed findings from FDA inspections conducted over 18 years, from 2007 (October 2006) to 2024 (December 2024), under the Bioresearch Monitoring (BIMO) Program. This study analyzed trends in findings related to clinical trials, targeting the ‘Institutional Review Board (IRB), Sponsor and Contract Research Organization (CRO), and Clinical Investigators (CI)’, and studied the correlation between type of findings by each center and Data Integrity. A total of 4,410 FDA Form 483 were issued, showing a significant decreasing trend over the years, the violation was Protocol compliance of 37%, followed by Inadequate management of case history records of 22% in findings of 6,277. This was also linked with the total Warning Letter issued of 336, with a distribution of Protocol compliance of 22% and Inadequate management of history records of 15%. Through the analysis of Warning Letters highlights the Protocol compliance, History records, Complying with approved documents(such as informed consent, meeting minutes, and procedures, etc.), and Reporting and Oversight. Furthermore, when analyzed in Data Integrity, the finding types of issued by each institution aligned with shared standards and oversight methods for inspection, and interventions to reduce violations(e.g., enhanced training, improved record management systems) were emphasized as effective strategies. Through this study, domestic/foreign companies or research institutes preparing for BIMO will recognize the importance of Data Integrity with violation type, and this study can serve as a reference for further improvement research.