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To conduct a statistical analysis of clinical trial visit time windows and propose targeted recommendations based on risk management from the perspective of the institutional office, so as to provide references for clinical research practice.
Data of drug clinical trial projects undertaken by a single institution from 2018 to 2024 were collected. Visit time windows were statistically analyzed and compared across the screening phase, visit phase, and follow-up phase. A risk classification standard for time windows was established by integrating management practice, regulatory requirements, and relevant literature. Corresponding recommendations were put forward for sponsors, researchers, participants, and the institutional office based on this classification.
A total of 137 projects were included, with the number of visits ranging from 1 to unlimited. Visit modalities included on-site visits and remote visits (telephone visits). The most prevalent time windows in each phase were 28 days (45.99%) for the screening phase, 3 days (62.26%) for the visit phase, and 7 days (68.93%) for the follow-up phase. The risk classification results were as follows: extremely high-risk time windows (1 to 30 minutes in the visit phase), high-risk time windows (42 to 183 days: before screening in the screening phase, 1 to 24 hours in the visit phase, and 1 to 3 days in the follow-up phase), medium-risk time windows (1 to 7 days: before screening in the screening phase, 1 to 3 days in the visit phase, and 5 to 10 days in the follow-up phase), and low-risk time windows (14 to 35 days: before screening in the screening phase, 4 to 14 days in the visit phase, and 14 to 30 days in the follow-up phase). Compared phase Ⅱ with phase Ⅲ or phase Ⅳ, statistically significant differences were all observed in the distribution of visit windows during the visit phase (all P<0.05). Based on this classification, the institutional office recommends that all parties adopt strategies of scientific design, risk-based response, and closed-loop management, and deeply understand and actively cooperate with each other for different risk levels of time windows.
Significant differences exist in visit time windows across different phases of clinical trials. Risk classification and targeted responses from all parties can effectively ensure the quality of clinical trial data and the rights and interests of participants.
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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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