Introduction to Food Supplementation in Clinical Trials Regulatory Considerations for Swissmedic / [or local responsible EU-CA] and Ethics Proposals Clinical trials involving food supplementation, such as α-D-glucose and 6,6’-d-glucose, require thorough planning and regulatory compliance due to their dual status as food substances and investigational products. While generally recognized as safe under normal dietary circumstances,… Continue reading General Safety & Performance Requirements — Normal and Deuterated-Glucose supplementation related documents
Tag: Swissmedic
Swissmedic: Switzerland’s regulatory authority for therapeutic products, ensuring safety, efficacy, and quality in healthcare.
Welcome to: “Swiss ClinO-MD & EU-MDR — Investigator Initiated Trials in MR-Research”
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”
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)
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
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)
Risk Analysis in 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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