NCT05047016

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19 Pneumonia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-13
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2021-09-16
• Last updated: 2021-11-05

Locations

2 sites across 1 country: South Korea