JNPMEDI's Global Research Center distributes the Korean version of the FDA's guidelines, "Digital Health Technologies for Remote Data Acquisition in Clinical Investments."
The guidelines which distributed by JNPMEDI is the Korean version of 'Digital Health Technologies for Remote Data Acquisition in Clinical Investments' published by the FDA at the end of December 2021. The FDA provided the guidelines to allow clinical research data to be collected remotely through digital health technologies (DHTs) such as mobile devices and software.
Details cover the selection and design of technologies suitable for remote data collection, how to verify the usefulness of technologies, risk management such as privacy, and data security. DHT for remote data collection stipulates that if an application required by the FDA is submitted in advance, it can be used without permission to sell general medical devices.
Through this guideline, it is expected that work efficiency will be improved by reducing the inconvenience of regular visits to clinical institutions by studying subjects in clinical trials.
The FDA is expected to collect opinions on these guidelines by the end of March and apply them to the clinical market. In Korea, regulators such as the Ministry of Food and Drug Safety have recently started to advance regulations in response to changes in the clinical trial environment, and changes in perception of Decentralized Clinical Trials (DCT) are being detected.
Recently, research on regulatory advancement due to changes in the post-COVID-19 clinical trial environment has been selected as an R&D task, and measures to improve clinical trial regulations are being promoted.
The guidelines which translated in Korean can be downloaded through the QR code or online link (https://mvn.do/jnpmedi-grc-01) in the article image.