Study to Evaluate the Dynamic Consent Model Based on the Blockchain-based Clinical Trial Platform METORY

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Virtual Clinical Trial to Implement and Evaluate the Dynamic Consent Model Based on the Blockchain-based Next-generation Clinical Trial Platform METORY

Conditions
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COVID-19 Pneumonia

Intervention / Treatment
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* Other: Virtual investigational product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who can use METORY (application platform) Subjects who completely understand the study and voluntarily decide to participate in the study Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dynamic consent arm<br>Subjects will receive a virtual investigational product once daily. Subjects also need to measure their body temperature once daily at the scheduled timepoint. | Other: Virtual investigational product<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response time | The time interval between notification of protocol amendment and subjects' response (consent) | Study Period of 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | Study Period of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blockchain, dynamic consent