Full
Outline
To explore the application effect of whole process quality control in phase Ⅰ clinical trial management.
A total of 96 subjects and 40 research nurses were included in the clinical trial. The group before the implementation of whole-process management (2018-01—2019-01) was regarded as the control group, and the traditional phase Ⅰ clinical trial management process was implemented. The group before the implementation of the whole process management (2019-06—2020-06) was regarded as the research group, and the implementation of the whole process quality control. Scale analysis was used to compare the compliance, shedding rate and satisfaction of the two groups of subjects. The management knowledge was evaluated.
The compliance of the study group was significantly higher than that of the control group (t=11.41, P<0.001). The drop off rate of the study group was significantly lower than that of the control group (χ2=3.215, P=0.036), and the satisfaction of the study group was significantly higher than that of the control group (t=8.984, P<0.001). The nursing staff management standard, nursing related standard operating procedures, first aid skills, practical skills, medical record writing, quality control related knowledge of the study group were better than those of the control group.
The implementation of whole process quality control in phase Ⅰ clinical trial quality management can improve the quality of phase Ⅰ clinical trial, improve the quality of nursing, and protect the rights and interests of subjects.
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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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