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To conduct a systematic analysis of the issues identified during routine quality control of clinical trials, investigate the root causes of quality problems in the trial implementation process, and explore improvement measures to enhance quality.
Issues identified in 255 routine quality control activities across 142 clinical trials from February 2023 to May 2025 were collected. These issues were categorized, aggregated, and subjected to statistical analysis.
A total of 248 issues were identified. These were primarily concentrated at the trial implementation level, specifically: 77 (31.05%) pertained to essential document management, 74 (29.84%) to the standardization of source records, 25 (10.08%) to the proper execution of informed consent forms, 23 (9.27%) to the completeness of source data, and 15 (6.05%) to the completeness of researcher credentials. Analysis of the causes indicated that these problems were mainly associated with ineffective researcher training, lack of active participation from investigators, deficiencies in the management and training of clinical research coordinators (CRCs), and insufficient quality control practices within specialty teams.
The institution exhibits a prominent proportion of issues related to essential document management and the standardization of source records. To reduce the occurrence of these problems and improve clinical trial quality, it is necessary to strengthen researcher training, enhance engagement, standardize CRC management, and improve the effectiveness of quality control within specialty teams.
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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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