A Virtual Clinical Trial to Implement and Evaluate the Dynamic Consent Model Based on the Blockchain-based Next-generation Clinical Trial Platform METORY
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Response time
研究概览
简要总结
Blockchain technology has gained attention for its decentralized feature and data integrity. The study aims to apply blockchain technology to implement dynamic consent model and evaluate the real-world experience as a form of virtual clinical trial.
详细描述
The study will simulate a clinical trial that implements dynamic consent module. In this study, two major and three minor protocol amendments will be conducted on the scheduled date. Each subjects will give consent using the dynamic consent platform, METORY, and will be informed when the protocol is amended. The communication only be conducted under the METORY and the real-world experience of METORY would be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who can use METORY (application platform)
- •Subjects who completely understand the study and voluntarily decide to participate in the study
排除标准
- •Subjects who are not able to use the web or application due to cognitive dysfunction or other reasons
- •Subjects who are not able to measure body temperature by themselves
- •Subjects who investigators decide not be appropriate for the study for other reasons
研究组 & 干预措施
Dynamic consent arm
Subjects will receive a virtual investigational product once daily. Subjects also need to measure their body temperature once daily at the scheduled timepoint.
干预措施: Virtual investigational product (Other)
结局指标
主要结局
Response time
时间窗: Study Period of 4 weeks
The time interval between notification of protocol amendment and subjects' response (consent)
次要结局
- Study completion rate(Study Period of 4 weeks)
- Dropout rate(Study Period of 4 weeks)
研究者
SeungHwan Lee
Professor
Seoul National University Hospital