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To sort out the previous on-site inspection of clinical trial data by the Center for Food and Drug Inspection (CFDI) of National Medical Products Administration (NMPA), to analyze and discuss the concerns and requirements of common problems in on-site inspection of drug clinical trial data after the implementation of the 2020 Good Clinic Practice (GCP), and to provide reference for the implementation and management of clinical trials.
We collected unqualified situation of the on-site verification of hospital's acceptance of CFDI data since July 22, 2015. A total of 21 items of clinical trials were included, among which 135 items were unqualified. For the common problems in the past non-conformities, the concerns and requirements of the 2020 version of GCP and on-site inspection were analyzed.
The previous unqualified items mainly focused on process records, as well as inspection and inspection of data traceability, program execution, safety event records, management and records of investigational drugs, biological sample circulation management, and the integrity of related data chains. The 2020 GCP and on-site verification points were quite different from the previous requirements regarding common problems in on-site verification of clinical trial data.
Under this new situation, it is necessary to change the previous concepts and rules, and carry out drug clinical trials according to the concerns and requirements of the 2020 version of GCP and the data on-site verification of drug clinical trials.
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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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