Abstract
This study evaluates the quality and efficiency of administrative review for investigator-initiated trials (IITs) at a leading tertiary hospital in Shandong Province, China. We conducted a retrospective empirical comparative analysis using feedback reports issued by the Clinical Research Management Office. A total of 151 reports from 2022 were compared with 162 reports from September 2023 to August 2024, after targeted improvement measures were introduced. Interventions focused on management enhancement, standardized submission templates, and systematic training. Results showed that incomplete study materials, insufficient informed consent information, inadequate researcher qualifications, and non-compliant signatures all decreased significantly (p < 0.05). The average number of issues per project declined from 3.76 to 3.10, and the proportion of high-quality submissions increased from 17.2% to 34.0% (p < 0.05). These results demonstrate that structured management and capacity-building measures can improve submission quality and review efficiency, offering practical pathways for optimizing oversight of IITs in medical institutions.
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