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Category: Practical Help (GPT Access)
In this category prescription related posts and active links to a GPT which developed with the aim to assist MR-scientists in quickly drafting required documents for Swissmedic and ethics committees.
Ethics proposal — The Clinical Investigation Plan (CIP)
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General Safety & Performance Requirements — Risk Analyses Overall System of Trial
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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)
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
General Safety & Performance Requirements — MR-scanner Related
Introduction to General Safety and Performance Requirements (GSPR) For anyone new to medical device trials, understanding General Safety and Performance Requirements (GSPR) is crucial. These requirements form the foundation of regulatory compliance under the European Medical Device Regulation (MDR) and Swissmedic’s / [or local responsible EU-CA] corresponding regulations. GSPR documents are essential in demonstrating that… Continue reading General Safety & Performance Requirements — MR-scanner Related
Investigator Brochure Builder-GPT
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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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