JNPMEDI distributes translated FDA guidelines for Decentralized Clinical Trials (DCT).

04 May 2023 · 5 minutes read

JNPMEDI expects that the evolving uses of electronic records, electronic systems, and electronic signatures in clinical investigations is important for FDA and other regulators in its assessment of the authenticity, integrity, and reliability of data submitted in support of marketing applications or submissions.

The JNPMEDI Global Research Center announced that it would distribute the Korean translation of the US Food and Drug Administration (FDA) Guidelines ‘Decentralized Clinical Trials for Drugs, Biological Products, and Devices’

This Guidance is a translation of 'Decentralized Clinical Trials for Drugs, Biological Products, and Devices' published by the FDA in May 2023, and is a clear guide to decentralized clinical trials (DCT).

It was issued in a situation where there were no guidelines related to DCT, and it is receiving a lot of attention from the clinical trial industry.

DCT conducts activities non-face-to-face in places other than hospitals. Since subjects do not have to visit the hospital in person, the recruitment and participation rates of clinical trials are increased and the progress is accelerated.

This document describes the DCT implementation process, from DCT design to door-to-door activities for remote clinical trials, utilization of digital health technology (DHT), and packaging and shipping of clinical trial products.

In Korea, clinical trials are still interpreted from a medical point of view, rather than for research purposes. Under current law, the absence of government guidelines related to non-face-to-face treatment, drug delivery, and electronic consent has been pointed out as obstacles to the introduction of DCT in Korea. In the midst of this, the FDA's DCT guidelines are expected to serve as an important reference for establishing domestic clinical trial-related laws and systems.

The Ministry of Health and Welfare plans to launch a new smart clinical trial technology development project this year. They will also form and operate a private consultative body this month to prepare DCT-related guidelines.

An official from the JNPMEDI Global Research Center said, "We expect this FDA guideline to be an important turning point, emphasizing the need to introduce DCT in Korea."

This document can be downloaded in the link as below: https://mvn.do/translations/2023-05-fda-dct-guidance

원문: https://www.fda.gov


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