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NCT05047016 Clinical Trial

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

COVID-19 Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05047016
Other study ID # METORY-101
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 13, 2021
Est. completion date November 2021

Study information
Verified date November 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date November 2021
Est. primary completion date November 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
Korea, Republic of Jeonbuk National University Hospital Jeonju Jeollabuk-do
Korea, Republic of Seoul National University Hospital Seoul Jongno-gu

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response time The time interval between notification of protocol amendment and subjects' response (consent) Study Period of 4 weeks
Secondary Study completion rate The proportion of subjects who completed the study Study Period of 4 weeks
Secondary Dropout rate The proportion of subjects who withdrew the study Study Period of 4 weeks
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