Full
Outline
To summarize and analyze the current situation of safety reporting requirements of drug clinical trial institutions in China after the implementation of the new “Good Clinical Practice” (GCP).
Data processing and statistical analysis were conducted on the reporting procedures and management requirements of safety events issued by 98 drug clinical trial institutions.
Fifty institutions (51.0%) required investigators to submit suspected unexpected serious adverse reactions (SUSAR) to ethics committees. A high proportion of institutions did not specify the media and time limit for SUSAR submission. There were 36 (36.7%) institutions that differentiated the time limit for SUSAR submission from sponsors to at least one role of investigators, ethics or trial management departments. The time limit for SUSAR at own hospitals was shorter than that from other hospitals and 7 or 15 d was the most common time limit. Forty-two (42.9%) institutions required investigators to report severe adverse events (SAE) to ethics committees and/or trial management departments.
Drug clinical trial institutions have timely updated the safety reporting requirements which focus on SUSAR and other safety events at own hospitals. It is necessary to further improve the clarity and convenience of safety reporting procedures and explore the management mechanism of safety events at the institution level.
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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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