Publications
80 publications
Sort by:
Subscribe to the latest documents
- Date
- Relevance
-
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
-
Simplified template of Annual Safety Report
-
E1/E2. Sample Subject Information Sheet
-
K3. Template Clinical Trial Agreement - industry-sponsored research
-
Flowchart Adverse events research with a medicinal product that is subject to the Dutch WMO Act