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

Not Applicable

• Conditions: COVID-19 Pneumonia
• Interventions: Other: Virtual investigational product

• Registration Number: NCT05047016
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-08
• Study Start: 2021-09-13
• Study First Posted: 2021-09-16
• Status Verified: 2021-11
• Primary Completion: 2021-11
• Study Completion: 2021-11
• Last Update Submitted: 2021-11-04
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dynamic consent arm	Virtual investigational product	Subjects will receive a virtual investigational product once daily. Subjects also need to measure their body temperature once daily at the scheduled timepoint.

Primary Outcome Measures

Name	Time	Method
Response time	Study Period of 4 weeks	The time interval between notification of protocol amendment and subjects' response (consent)

Secondary Outcome Measures

Name	Time	Method
Study completion rate	Study Period of 4 weeks	The proportion of subjects who completed the study
Dropout rate	Study Period of 4 weeks	The proportion of subjects who withdrew the study

Trial Locations

Locations (2)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of

Jeonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of