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Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus
D2. IMDD template
K3. Template Clinical Trial Agreement for investigator-initiated research for use with VGO
K3. Template Clinical Trial Agreement for industry-sponsored research for use with VGO
Flowchart Adverse events research with a medical device
E1/E2. Template Subject Information Sheet (English)
E1/E2. Template Subject Information Sheet (Dutch)
Decree 2014 containing rules for compulsory insurance in medical research involving human subjects and explanatory memorandum
Review of a clinical investigation with a medical device – guidance document for MRECs
As of 26 May 2021, the EU Medical Device Regulation (MDR) will be applicable. This guidance sets out the implications for the ...