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

NCT ID: NCT05047016

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-13

Study Completion Date

2021-11-30

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.

Conditions

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COVID-19 Pneumonia

Keywords

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blockchain, dynamic consent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Virtual investigational product

Intervention Type 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.

Interventions

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Virtual investigational product

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.

Intervention Type OTHER

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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SeungHwan Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SeungHwan Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Jeonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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METORY-101

Identifier Type: -

Identifier Source: org_study_id