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Overview of assessment criteria described in MDR
K3. Template Clinical Trial Agreement – non-WMO research
E1/E2. Manual templates subject information sheets for research subjects <16 years of age (children) (Dutch)
E1/E2. Template subject information sheet for children between the ages of 12 and 16 (Dutch)
E1/E2. Simplified template for children up to the age of 12 (Dutch)
K3. Template Clinical Trial Agreement - investigator-initiated research
Standard research file Explanation
Explanation of the standard research file and the explanation of codes and document titles for digital submission.