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Investigator initiated trial (IIT) contracts serve as critical legal documents defining the rights and responsibilities of all parties involved in clinical research. This study systematically analyzed issues identified during the review of IIT contracts at a medical institution, explored the underlying causes, and proposed targeted risk prevention and control measures.
A retrospective analysis was conducted on IIT contracts reviewed at a medical institution from January and December 2025. Common issues identified during contract review were summarized and categorized. Distribution patterns and contributing factors were systematically examined.
A total of 96 IIT contracts were reviewed and 917 issue instances were identified. These issues were primarily categorized as follows: legal rights and responsibilities (36.86%, 338 cases/917 cases), protection of research participants’ rights and ethics (6.22%, 57 cases/917 cases), resources and funding management (17.78%, 163 cases/917 cases), data and intellectual property (20.72%, 190 cases/917 cases) and risks associated with human genetic resources (18.43%, 169 cases/917 cases). These issues posed potential risks for medical disputes, commercial bribery, and administrative penalties. Consequently, this study proposed core risk prevention strategies including defining key stakeholder responsibilities, strengthening participant protection, optimizing the management of research funding and conflicts of interest, establishing robust frameworks for intellectual property protection and data privacy, and enforcing strict oversight of human genetic resources.
IIT contracts management requires strengthened review of key elements and establishment of a comprehensive contract management system. The findings provide a practical reference for medical institutions to optimize IIT contract management, thereby supporting the high quality development of clinical research.
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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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