7. Decentralized Clinical Trials

7.1 Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)?

Yes. There are currently no regulations preventing the conduct of DCTs in Korea. 

7.2 Is there any specific regulation/guidance on the use of DCT elements within a clinical trial?

There is not yet any specific guidance on the inclusion of DCT elements in a clinical trial. These are subject to approval by the ethics committee.  

7.3 What is the overall acceptability of DCT elements by the regulatory authorities and Ethics Committees?

There is not yet any specific guidance on the inclusion of DCT elements in a clinical trial. These are subject to approval by the ethics committee. 

Korea has developed its regulatory landscape enormously in the last decade and will likely embrace DCTs in the future. Currently, DCT elements are subject to IRB approval.

7.4 Has a fully virtual trial (DCT) been conducted in the country yet? If so, please provide an example including the registration number and any link to it, whether COVID/non-COVID trials.

No, fully virtual DCTs have not been conducted yet in Korea. However, there are a number of organizations looking to implement DCTs and hybrid trials.

7.5 Are there any non-regulatory DCT initiatives in the country, such as where the investigator sites and local CROs founded an alliance?

There are no specific industry initiatives around DCTs. However, a number of companies are pushing for the introduction of virtual trials. See the example below from 3H Medi. 

https://global-3h.com/2021/07/01/home-based-clinical-trials-in-south-korea-and-3h-initiative/

7.6 Are there any general considerations when using DCT elements in a study?

No. 

7.7 Considerations/Requirements for the Use of eConsent/Remote Consent

There is no specific guidance around this matter. However, electronic sign-off is becoming increasingly common for aspects of trial conduct.

7.8 Considerations/Requirements for the Use of eSignatures

E-Signature Legality Summary

Electronic signatures are governed by the Digital Signature Act and the Framework Act on Electronic Documents and Transactions of Korea.

Types of Electronic Signature

An electronic signature that can identify the signatory and establish that the electronic signature was signed by the same signatory is a valid electronic signature and is acceptable under the Digital Signature Act of Korea. Under the Digital Signature Act of Korea, the enforceability of an electronic signature as a valid signature, signature and seal, or name and seal is not denied solely on the fact that the signature is in an electronic form. If the relevant statutes or regulations, or the agreement between the parties to a contract, permit the use of an electronic signature as a valid signature, signature and seal, or name and seal, such electronic signature is enforceable.

For certified electronic (digital) signatures, the Digital Signature Act of Korea has set forth and publicly announced Guidelines on Electronic Signature Certification Services (the “Guidelines”). Such enhanced electronic (digital) signatures can be certified upon assessment of compliance with the requirements under the Guidelines.

Documents That May be Signed Electronically

Any contract may be signed with an electronic signature, except in general, for surety contracts.

Further Guidance

Generally, there are no restrictions on the use of electronic signatures.

In relation to documents relating to corporate resolutions, the use of electronic signatures for minutes of general meetings of shareholders or board of directors’ meetings is, in principle, permitted. However, if such corporate resolution contains a “registrable matter” and the relevant documents must be submitted to a corporate registration court, such documents are, in practice, affixed with personal or corporate seals, in lieu of electronic signatures. Proceeding with the registration of a registrable matter based on electronically signed minutes may pose difficulties in relation to the preparation of necessary documents.

In addition, as government filings are official documents, rather than “contracts,” the use of electronic signatures for the relevant documents may be accepted at the discretion of the relevant government authority, although there are no legal restrictions on the use of electronic signatures. 

https://www.docusign.com/products/electronic-signature/legality/south-korea/ 

7.9 Considerations/Requirements for Electronic Patient Reported Outcome (ePRO)

There is no specific guidance around this.

7.10 Considerations/Requirements for Home Health Care (HHC) - Home Nursing

There are no specific regulations relating to DCTs in Korea. However, aspects of virtual trials and home healthcare are becoming increasingly common, particularly in relation to specific populations such as the elderly.

7.11 Considerations/Requirements for HHC - Home Lab Collection

According to a blog published by the Korea Biomedical Review - ‘Decentralized clinical trials need deregulation, detailed guidelines’ - there are currently no regulations regarding HHC but there is hope for it in the future.

Implying that the clinical trial environment centered on institutions could be changed with DCT, she said, “Collecting blood samples or testing patients can be done through a local medical facility rather than an institution, and the research institute or sponsor can collect the data remotely with DCT service.”

7.12 Considerations/Requirements for Direct-to-Patient Study Product Delivery

As above, there are no specific regulations in place relating to DCTs and home care.

7.13 Considerations/Requirements for the Use of Telemedicine

While telemedicine is technically illegal in South Korea and has only been allowed under emergency use since the introduction of COVID-19 measures in 2020, the increase in its users and support from President-elect Yoon Suk-Yeol who sees it as an "inevitable reality" suggest it may remain part of the healthcare system.

https://www.reuters.com/business/healthcare-pharmaceuticals/telemedicine-booms-skorea-amid-covid-president-elect-yoon-backs-practice-2022-03-22/ 

7.14 Considerations/Requirements for the Use of Wearables

There is no specific guidance around this.

7.15 Considerations/Requirements for Remote Monitoring

There is no specific guidance around this.

7.16 Considerations/Requirements for Digital Health Technologies (such as Platforms)

There is no specific guidance around this and it is managed by the IRB.