Navigating the world of clinical trial compliance can feel like a journey through a bureaucratic labyrinth, or worse, a modern-day compliance inquisition. When I set out to write my combined Swissmedic and ethics proposals for a research study in MRI, I knew it would be challenging. But nothing prepared me for the sheer scale of… Continue reading Welcome to: “Swiss ClinO-MD & EU-MDR — Investigator Initiated Trials in MR-Research”
Tag: Swiss Federal Human Research Act (HRA
Ethics proposal — The Clinical Investigation Plan (CIP)
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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)
Registering Ethics Proposal at BASEC and filling out BASEC project form
Introduction This post ONLY describes how a medical device MR trial proposal can be submitted in Switzerland. In the EU this will different and will depend on the country and local ethics committee rules that apply. The post describes the data that was entered for the SIGNATURES2023 trial, and for your study this will be… Continue reading Registering Ethics Proposal at BASEC and filling out BASEC project form
Lead EC: General and main site’s documents
Essential BASEC Documents for Ultra-High Field MR Projects Discover the key documents required for submitting an in vivo MR project to BASEC/your local EU-CA/[your local EU-CA/ethics committee], focusing on investigations using non-CE-marked RF coils and pulse sequences, not necessarily, at ultra-high field strengths. In the Table below you find all the documents uploaded to BASEC… Continue reading Lead EC: General and main site’s documents
Demystifying the Investigator’s Brochure: A Comprehensive Guide to Preclinical Testing, Device Interactions, and Regulatory Compliance for Swissmedic and KEK Submissions
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Revision of Human Research in Switzerland — The Revised HRA Ordinances
Switzerland has taken a significant step forward in regulating human research with the revision of the Human Research Act (HRA) ordinances. Approved by the Federal Council, the updated ordinances, designed to reflect advancements in digitalization, national and international standards, and research practices, officially came into effect on 1 November 2024. However, provisions on transparency will… Continue reading Revision of Human Research in Switzerland — The Revised HRA Ordinances
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