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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05047016

Enrollment

Registered

2021-09-16

Start date

2021-09-13

Completion date

2021-11-30

Last updated

2021-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pneumonia

Keywords

blockchain, dynamic consent

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.

Interventions

OTHERVirtual 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026