Tag: AI aided CIP generation

The use of artificial intelligence to streamline the creation of Clinical Investigation Plans, ensuring accuracy, efficiency, and regulatory compliance.

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

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