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  1. Overview of assessment criteria described in MDR

    Publication | 15-01-2020

  2. K3. Template Clinical Trial Agreement – non-WMO research

    Form | 01-01-2020

  3. E1/E2. Manual templates subject information sheets for research subjects <16 years of age (children) (Dutch)

    Publication | 14-10-2019

  4. E1/E2. Template subject information sheet for children between the ages of 12 and 16 (Dutch)

    Form | 14-10-2019

  5. E1/E2. Simplified template for children up to the age of 12 (Dutch)

    Form | 14-10-2019

  6. K3. Template Clinical Trial Agreement - investigator-initiated research

    Form | 20-09-2019

  7. Simplified template of Annual Safety Report

    Publication | 31-01-2019

  8. E1/E2. Sample Subject Information Sheet

    Publication | 14-01-2019

  9. K3. Template Clinical Trial Agreement - industry-sponsored research

    Form | 18-12-2018

  10. Flowchart Adverse events research with a medicinal product that is subject to the Dutch WMO Act

    Publication | 27-11-2018

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