You need to be logged in to view this content. Please Log In. Not a Member? Join Us
Tag: missing CE-marking
Ethics proposal — The Clinical Investigation Plan (CIP)
You need to be logged in to view this content. Please Log In. Not a Member? Join Us
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)
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
Risk Analysis in MR Medical Device Trials
You need to be logged in to view this content. Please Log In. Not a Member? Join Us
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
Investigator Brochure Builder-GPT
You need to be logged in to view this content. Please Log In. Not a Member? Join Us
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
You need to be logged in to view this content. Please Log In. Not a Member? Join Us
You must be logged in to post a comment.