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Discussion and Work Experience Sharing of Real-World Data Quality Control in the Clinical Comprehensive Evaluation of Drugs
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YIN Wenjun, XIE Yueliang, HUANG Yujie, PIAO Huiling, ZUO Xiaocong*
Chinese Pharmaceutical Journal | 2024, 59(4) : 369 - 374
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Chinese Pharmaceutical Journal | 2024, 59(4): 369-374
Discussion and Work Experience Sharing of Real-World Data Quality Control in the Clinical Comprehensive Evaluation of Drugs
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YIN Wenjun, XIE Yueliang, HUANG Yujie, PIAO Huiling, ZUO Xiaocong*
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  • The Third Xiangya Hospital of Central South University, Changsha 410013, China
Published: 2024-02-22 doi: 10.11669/cpj.2024.04.011
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OBJECTIVE To explore the quality control of real-world data in the drug clinical comprehensive evaluation, and promote the scientific and rational application of real-world data in the drug comprehensive clinical evaluation. METHODS Literature on the quality control of real-world research data in drug clinical comprehensive evaluation was reviewed, and the work experience of the drug clinical comprehensive evaluation center in the province where the author is located was integrated to explore the content and process of quality control of real-world research data in drug clinical comprehensive evaluation. RESULTS AND CONCLUSION Quality control of real-world research data generally includes internal and external controls. Evaluation methods comprise qualitative assessment, quantitative assessment, and comprehensive assessment. The implementation phase can be divided into the project initiation phase and the data governance phase, with a round of data quality control conducted in each phase. This study summarizes the content and process of quality control for real-world research data in the drug clinical comprehensive evaluation, providing a reference for researchers and decision-makers to correctly produce and use evidence from real-world data for drug clinical comprehensive evaluation.

drug clinical comprehensive evaluation  /  real-world data  /  quality control
YIN Wenjun, XIE Yueliang, HUANG Yujie, PIAO Huiling, ZUO Xiaocong. Discussion and Work Experience Sharing of Real-World Data Quality Control in the Clinical Comprehensive Evaluation of Drugs[J]. Chinese Pharmaceutical Journal, 2024 , 59 (4) : 369 -374 . DOI: 10.11669/cpj.2024.04.011
Year 2024 volume 59 Issue 4
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doi: 10.11669/cpj.2024.04.011
  • Receive Date:2022-10-14
  • Online Date:2025-11-13
  • Published:2024-02-22
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  • Received:2022-10-14
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    The Third Xiangya Hospital of Central South University, Changsha 410013, 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
total species (%)

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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