| Korean Translation of FDA Guidance on Electronic Records & Signatures Released…Supporting Compliance and Use of Electronic Systems in Clinical Research
JNPMEDI (CEO Kwunho Jeong) announced on the 18th, the distribution of the Korean version of FDA’s latest guidance, "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Question and Answers". This guidance contains recommendations to ensure reliability and integrity of electronic system and records, and addresses the use of electronic signature that is considered as legally equivalent to handwritten signatures.
This document provides guidance on the use of electronic systems, records, and signatures in clinical investigation of foods, medical products, tobacco products, and new animal drugs to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties. This guidance specifically outlines the conditions under which electronic records and signatures hold the same legal validity as paper records and handwritten signatures, as well as risk management strategies associated with the use of electronic systems.
JNPMEDI is actively supporting digital transformation of the local clinical trial industry by promptly translating and distributing these global guidelines.
Jonghyun Park, Director of JNPMEDI Global Research Center stated, “This translation will contribute to clinical researchers in Korea to work with electronic records and systems more efficiently, and be a great help to digitization and improved efficiency of clinical trial processes.”
Full translation is available on JNPMEDI’s official website.
▶ Download the Translated Version Here
https://form.typeform.com/to/MJLzfbmG
| Korean Translation of FDA Guidance on Electronic Records & Signatures Released…Supporting Compliance and Use of Electronic Systems in Clinical Research
JNPMEDI (CEO Kwunho Jeong) announced on the 18th, the distribution of the Korean version of FDA’s latest guidance, "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Question and Answers". This guidance contains recommendations to ensure reliability and integrity of electronic system and records, and addresses the use of electronic signature that is considered as legally equivalent to handwritten signatures.
This document provides guidance on the use of electronic systems, records, and signatures in clinical investigation of foods, medical products, tobacco products, and new animal drugs to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties. This guidance specifically outlines the conditions under which electronic records and signatures hold the same legal validity as paper records and handwritten signatures, as well as risk management strategies associated with the use of electronic systems.
JNPMEDI is actively supporting digital transformation of the local clinical trial industry by promptly translating and distributing these global guidelines.
Jonghyun Park, Director of JNPMEDI Global Research Center stated, “This translation will contribute to clinical researchers in Korea to work with electronic records and systems more efficiently, and be a great help to digitization and improved efficiency of clinical trial processes.”
Full translation is available on JNPMEDI’s official website.
▶ Download the Translated Version Here
https://form.typeform.com/to/MJLzfbmG