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Category: Risk management
Build a regulator-ready Clinical Investitor Plan for MRI/MRS trials
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The CIP-creator GPT input yaml file
Detailed Description of CIP-Intake YAML This page explains the CIP-Intake YAML used by the MR-clinical-trial-CIP-Creator GPT to validate your inputs and generate a regulator-aligned Clinical Investigation Plan (CIP) skeleton for CH and/or EU submissions. Download YAML Empty example.yaml file What the YAML is for File rules & formatting Minimal valid example Full scaffold… Continue reading The CIP-creator GPT input yaml file
General Safety & Performance Requirements — Normal and Deuterated-Glucose supplementation related documents
Introduction to Food Supplementation in Clinical Trials Regulatory Considerations for Swissmedic / [or local responsible EU-CA] and Ethics Proposals Clinical trials involving food supplementation, such as α-D-glucose and 6,6’-d-glucose, require thorough planning and regulatory compliance due to their dual status as food substances and investigational products. While generally recognized as safe under normal dietary circumstances,… Continue reading General Safety & Performance Requirements — Normal and Deuterated-Glucose supplementation related documents
General Safety & Performance Requirements — 1H/2H-dual tuned RF-coil related
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Ethics proposal — The Clinical Investigation Plan (CIP)
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General Safety & Performance Requirements — Risk Analyses Overall System of Trial
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Ethics proposal — The Clinical Investigation Plan (CIP)
Introduction Navigating the bureaucracy behind clinical trials in Switzerland is no small feat. As a researcher preparing the SIGNATURES2023 study, I quickly found that working with both the local Cantonal Ethics Commission (CEC) and Swissmedic / EMA — two independent bodies with their own rules and regulations — requires a level of coordination and compliance that… Continue reading Ethics proposal — The Clinical Investigation Plan (CIP)
General Safety & Performance Requirements — MR-scanner Related
Introduction to General Safety and Performance Requirements (GSPR) For anyone new to medical device trials, understanding General Safety and Performance Requirements (GSPR) is crucial. These requirements form the foundation of regulatory compliance under the European Medical Device Regulation (MDR) and Swissmedic’s / [or local responsible EU-CA] corresponding regulations. GSPR documents are essential in demonstrating that… Continue reading General Safety & Performance Requirements — MR-scanner Related
Risk Analysis in MR Medical Device Trials
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