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
Tag: EMA
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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The Importance of a Monitoring Plan in MR Medical Device Studies
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