Full
Outline
To identify the quality risks of medical records in clinical research and propose strategies according to the risk levels.
By analyzing the quality inspection findings of clinical research in the recent 3 years, the quality risks of medical records in clinical research were identified. The risk coefficient was obtained by multiplying the degree of risk influence with the possibility of occurrence, and the risk grade was evaluated according to the risk coefficient.
A total of 54 risks were identified, mostly medium and low risks. The only high risk is inconsistent recording of the same data in different source files. Incomplete records, insufficient records to determine the clinical significance of detection outliers, missing adverse events and incomplete or incorrect records of adverse event elements are common risks of medical record quality, and the risk coefficient of which is second to the only high risk. Other risks with low risk coefficients are infrequently met.
The risk of medical record quality exists in every link of clinical study. Clinical research related personnel can establish the initial priority of risk treatment according to risk level and coefficient.
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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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