Trusted Resource for Clinical Trials, Protocols & Progress
This SOP describes the process for preparing, submitting, and managing Clinical Trial Notifications (CTNs), amendments, safety reports, and trial notifications to the Pharmaceuticals and Medical Devices Agency (PMDA). It ensures alignment with Japanese Good Clinical Practice (J-GCP), the PMD Act, and ICH-GCP guidelines to protect participant safety, maintain regulatory compliance, and ensure inspection readiness.
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This SOP defines the process for preparing, translating, reviewing, and controlling Japanese language informed consent forms (ICFs) and essential clinical trial documentation. It ensures participant comprehension, regulatory compliance with PMDA and J-GCP, and alignment with ICH guidelines on subject information and documentation governance.
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This SOP describes the requirements and processes for safety reporting to the Pharmaceuticals and Medical Devices Agency (PMDA). It defines obligations for sponsors, investigators, and pharmacovigilance teams for expedited reporting of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and other reportable events in compliance with Japanese Good Clinical Practice (J-GCP) and international pharmacovigilance standards.
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This SOP defines the standardized process for site data submission formatting and translation quality assurance (QA) for clinical trials conducted under the oversight of the Pharmaceuticals and Medical Devices Agency (PMDA). It ensures that site-level documents and datasets submitted in Japanese or translated from English are accurate, compliant with J-GCP, and ready for regulatory inspection.
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