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D2. IMDD-MDR template
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Template Clinical Trial Agreement for investigator-initiated research for use with VGO
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Template Clinical Trial Agreement for industry-sponsored research for use with VGO
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Flowchart Adverse events research with a medical device
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Decree 2014 containing rules for compulsory insurance in medical research involving human subjects and explanatory memorandum
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CCMO Memorandum Flowcharts deferred consent for medical research in emergency situations
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Overview of assessment criteria described in MDR
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K3. Template Clinical Trial Agreement – non-WMO research
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E1/E2. Manual templates subject information sheets for research subjects <16 years of age (children) (Dutch)
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E1/E2. Template subject information sheet for children between the ages of 12 and 16 (Dutch)