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Links Archive
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EU Guidelines on COVID-19 and clinical trials
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Brexit: MHRA new rules for January 2021 |
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FAQs on the UDI system |
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ISO 14155:2020 Clinical investigation of medical devices – Good clinical practice
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CCMO on Brexit and clinical research
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MDCG Clinical Guidances
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Guiding principles of international regulators for COVID-19 clinical trials |
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WHO guideline on data integrity for comment
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MDR (EU-2017/745) & corrigenda
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Do’s and don’t’s to keep in mind during GCP inspections |
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Medical device manufacturers required to post clinical trial data from trials conducted before HHS’s Final Rule in January 2017?
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Mandatory MIR Form
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MHRA clinical investigation links
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IVDR (EU-2017/746) & corrigenda
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CIOMS’ free e-learning on the International Ethical Guidelines for Health-related Research Involving Humans
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IMDRF guidances on clinical evaluation
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ISO 20916:2019 – IVDs – Clinical performance studies using specimens from human subjects