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To examine issues in sample management within drug clinical trials, their implications on subject rights, data integrity, and propose targeted enhancements.
A retrospective analysis was conducted on 69 clinical trial projects, encompassing bioequivalence and innovative drug phase I-IV trials, processed by the phase I clinical trial laboratory at our institution from April 2018 to December 2024. Problems in biological sample management were identified through monitoring records maintained by quality control professionals, institutional quality control personnel, and clinical research monitors. The distribution patterns of issues were analyzed, and non-standard problems were assessed and categorized using the protocol deviation (PD) evaluation system.
A total of 68 issues were identified in biological sample management, primarily centered around sample collection (27.94%), processing (19.12%), and preservation (36.76%). PD evaluations indicated that deficiencies in operational processes (e.g., non-compliance with standard operating procedures), insufficient personnel training, and irregular documentation were the primary underlying causes.
Comprehensive standardized management strategies, including enhancing standardized procedures in critical stages, improving personnel training, quality control frameworks, and implementing intelligent information systems, are essential to ensure the provision of dependable sample support for high-caliber clinical research.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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