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
Category: Swissmedic Proposal-Related Writing
In this category posts appear which are predominantly related to making Swissmedic proposals and administrative process and communicating with Swissmedic.
Introduction to AI-aided proposal generation
🇨🇭🇪🇺 Introduction to AI-Aided Document Creation for Single-Center MRI Trials with Non CE-marked Devices and/or Pulse-Sequences The specialized GPT-s below focuses on preparing documents exclusively for single-center MRI/MRS clinical investigations that involve non CE-marked pulse sequences (like WIP or IDEA sequences) and/or non CE-marked hardware (like site-built RF coils). This includes trials typically requiring Category… Continue reading Introduction to AI-aided proposal generation
Case Report Forms (CRFs)
Introduction Case Report Forms (CRFs) are standardized documents used to systematically collect and record data during clinical investigations, ensuring consistency, accuracy, and completeness in documenting research outcomes. They are critical for capturing patient demographics, medical history, investigational procedures, adverse events, and study outcomes in alignment with the study protocol. CRFs are required by regulatory bodies,… Continue reading Case Report Forms (CRFs)
Developing a Risk Management Report for MR Medical Device Trials
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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
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