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

Seoul National University

Status: Unknown

Conditions: COVID-19 Pneumonia

Treatments: Other: Virtual investigational product

Study type: Interventional

Funder types: Other

Identifiers

NCT05047016

METORY-101

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Dynamic consent arm

Other group

Description:

Subjects will receive a virtual investigational product once daily. Subjects also need to measure their body temperature once daily at the scheduled timepoint.

Treatment:

Other: Virtual investigational product