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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic consent arm | Other | Subjects will receive a virtual investigational product once daily. Subjects also need to measure their body temperature once daily at the scheduled timepoint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual investigational product | Other | The virtual investigational product is a predefined text (e.g. AB123F). By entering the code into the application, the virtual 'administration' of the IP is conducted. |
| Measure | Description | Time Frame |
|---|---|---|
| Response time | The time interval between notification of protocol amendment and subjects' response (consent) | Study Period of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Study completion rate | The proportion of subjects who completed the study | Study Period of 4 weeks |
| Dropout rate | The proportion of subjects who withdrew the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SeungHwan Lee, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeonbuk National University Hospital | Jeonju | Jeollabuk-do | 54907 | South Korea | ||
| Seoul National University Hospital |
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| Study Period of 4 weeks |
| Seoul |
| Jongno-gu |
| 03080 |
| South Korea |