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OBJECTIVE To explore investigator-initiated trial(IIT) approval management with a focus on risk prevention and control in the absence of guidelines for IIT approval management. METHODS Through a combination of literature review and practical experiences, this study analyzed the challenges encountered in the approval process and explored its potential risks, outlined the approval process following the promulgation of the management regulations, summarized its key aspects, and assessed the significance of the approval process with a focus on risk prevention and control.RESULTS There exist inherent risks in areas such as research design, participant protection, research team dynamics, and research funding. The authors advocate for the implementation of compliance review, peer expert evaluation, and a hierarchical approval review by expert technical committee, emphasizing scrutiny of scientific validity, feasibility, and funding adequacy. CONCLUSION The proactive identification and prevention of potential risks are highlighted as crucial benefits of the approval management. Centralized management of IIT projects, development of data management platforms, and diversification of funding channels to enhance risk mitigation should be further explored.
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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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