Full
Outline
To analyze the new requirements imposed on principal investigators and clinical trial institutions by the revised Good Clinical Practice (GCP) guidelines, and to explore the challenges currently facing the industry along with corresponding response strategies.
Through an in-depth interpretation of the revised GCP provisions and a comparative analysis with the 2020 version, integrated with the core principles of ICH E6(R3), this study examined compliance and the current status from the perspectives of legal liability delineation, participant protection, data integrity, and quality management system development.
The legal status of the principal investigator as the “ultimate responsible party at the clinical trial site” was established, and it was proposed that clinical trial institutions should build and ensure the effective operation of a full process quality management system. In addition, an intelligent management pathway was identified, embedding digital tools into management processes to address practical challenges including technical barriers, cost investments, and cognitive biases.
The implementation of the revised GCP signifies a shift in China’s clinical trial management from the former “compliance oriented” approach toward “quality-by-design” and “risk-based” approaches. Principal investigators and clinical trial institutions should leverage digital transformation and the co-evolution of management paradigms to create an intelligent quality ecosystem, achieving a substantial leap in clinical trial performance while maintaining full regulatory compliance.
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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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