J&P Medi Distributes Korean Translation of FDA's Latest Electronic System Guidelines

J&P Medi announced on the 18th that it will distribute the Korean translation of the latest guidelines from the U.S. Food and Drug Administration (FDA), titled “Questions and Answers on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Research.”

These guidelines cover the use of electronic signatures with the same legal effect as paper records, including recommendations to ensure the reliability and integrity of electronic systems and records. The guidelines target various stakeholders such as sponsors, clinical researchers, Institutional Review Boards (IRB), and Contract Research Organizations (CRO). They provide essential information on utilizing electronic systems, records, and electronic signatures in clinical research involving medical products, food, tobacco products, and new drugs. In particular, the guidelines include conditions for electronic records and signatures to have the same legal effect as paper records and handwritten signatures, as well as risk management measures related to the use of electronic systems.

Jonghyun Park, Head of the Global Research Center at J&P Medi, said, “This translation will contribute to domestic clinical researchers’ more efficient use of electronic records and systems, and it will greatly help digitalization and efficiency improvement in the clinical trial process.”

The translated version is available for download on the official J&P Medi website.