Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to define processes for submitting clinical trial applications and related documentation to the Ministry of Food and Drug Safety (MFDS) in South Korea, while ensuring full alignment with Korean Good Clinical Practice (KGCP). It ensures that sponsor and investigator obligations are fulfilled in compliance with local regulations and international GCP standards.
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This SOP defines processes for managing electronic source (eSource) and eClinical data in clinical trials conducted in South Korea. It ensures compliance with MFDS regulations, Korean Good Clinical Practice (KGCP), and international GCP standards regarding data integrity, authenticity, confidentiality, and retention.
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This SOP defines requirements for preparing informed consent forms (ICFs) and essential documents in the Korean language, ensuring cultural, linguistic, and regulatory compliance. It ensures participant comprehension, ethical compliance, and alignment with MFDS and Korean GCP standards.
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The purpose of this SOP is to establish a standardized process for local pharmacovigilance (PV) reporting and audits in South Korea. It ensures compliance with Ministry of Food and Drug Safety (MFDS) regulations, Korean Good Clinical Practice (KGCP), and international safety reporting standards, thereby safeguarding trial participants and ensuring data integrity.
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This SOP establishes standardized procedures for local pharmacovigilance (PV) reporting and audits in South Korea. It ensures compliance with MFDS safety reporting timelines, Korean GCP (KGCP), and international guidelines, thereby protecting patient safety and ensuring inspection readiness.
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