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Exploration and practice of remote supervision and inspection in drug clinical trial institutions
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Jun-jie ZHU1, Zhen DONG2, Xian-fu MA3, Zhao YAN4, Hui LI5
Chinese Journal of New Drugs | 2023, 32(9) : 921 - 926
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Chinese Journal of New Drugs | 2023, 32(9): 921-926
Exploration and practice of remote supervision and inspection in drug clinical trial institutions
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Jun-jie ZHU1, Zhen DONG2, Xian-fu MA3, Zhao YAN4, Hui LI5
Affiliations
  • 1Hebei Provincial Drug Administration, Shijiazhuang 050091, China
  • 2Center for Drug Evaluation of Hebei Province, Shijiazhuang 050024, China
  • 3Tianjin Bekn Medical Technology Co., Ltd., Tianjin 300000, China
  • 4Continuing Education and Science and Technology Service Department of China Anti Cancer Association, Tianjin 300384, China
  • 5Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050200, China
Published: 2023-05-15
Outline
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In recent years, with the continuous innovation and transformation of the pharmaceutical industry, high-quality and efficient clinical trials have become one of the most important demands of the pharmaceutical industry at present. The drug clinical trial business is complicated and data volume is huge, putting forward higher requirements for drug supervision. Therefore, innovative regulatory methods and intelligent transformation are extremely in need. In order to meet various development requirements in the era of COVID-19, after years of exploration and practice, our province has started the construction of the supervision information system of drug clinical trial institutions in Hebei province, established a vertical supervision system from top to bottom, and realized the whole-process reengineering of the supervision of clinical trial institutions by means of information technology. We initiated the remote supervision mode of drug clinical trial institutions and explored the "on-site inspection-remote inspection" hybrid supervision and inspection mode. With the assistance of this system, the risk in the clinical trial process reduced, the personnel gathering under the COVID-19 epidemic reduced, while the efficiency of supervision and inspection is improved, the listing process of new and good drugs is accelerated, makingpeople easily access to good drugs as soon as possible.

clinical trials  /  remote supervision  /  informatization  /  risk management
Jun-jie ZHU, Zhen DONG, Xian-fu MA, Zhao YAN, Hui LI. Exploration and practice of remote supervision and inspection in drug clinical trial institutions[J]. Chinese Journal of New Drugs, 2023 , 32 (9) : 921 -926 .
Year 2023 volume 32 Issue 9
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  • Online Date:2026-03-05
  • Published:2023-05-15
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  • Accepted:2022-09-22
Affiliations
    1Hebei Provincial Drug Administration, Shijiazhuang 050091, China
    2Center for Drug Evaluation of Hebei Province, Shijiazhuang 050024, China
    3Tianjin Bekn Medical Technology Co., Ltd., Tianjin 300000, China
    4Continuing Education and Science and Technology Service Department of China Anti Cancer Association, Tianjin 300384, China
    5Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050200, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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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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