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: MRI
A non-invasive imaging technology that uses magnetic fields and radio waves to visualize detailed structures and functions within the body.
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
Background of this Blog: Personal Experience
Thirty years ago, the landscape of MRI research and clinical trials was a very different world compared to the complex regulatory environment we navigate today. Back then, conducting an MR study required little a few A4 page sized proposal submitted to the local ethics committee here in Bern. It was a time when innovation flourished… Continue reading Background of this Blog: Personal Experience
How to Apply for an Ethics Approval for your MR-research
🇨🇭 How to Apply for an Ethics Approval for Your MR-Research Navigating the ethics approval process for your MR research can be a daunting task, particularly when investigator-initiated trials (IIT) and strict legal compliance are involved. Even after securing funding from organizations like the Swiss National Science Foundation (SNSF) or the EU Commission, the real… Continue reading How to Apply for an Ethics Approval for your MR-research
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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