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  1. Flowchart Adverse events research with a medical device

    Publication | 06-10-2020

  2. Decree 2014 containing rules for compulsory insurance in medical research involving human subjects and explanatory memorandum

    Publication | 12-08-2020

  3. CCMO Memorandum Flowcharts deferred consent for medical research in emergency situations

    Publication | 07-04-2020

  4. Overview of assessment criteria described in MDR

    Publication | 15-01-2020

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

    Form | 01-01-2020

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

    Publication | 14-10-2019

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

    Form | 14-10-2019

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

    Form | 14-10-2019

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

    Form | 20-09-2019

  10. Simplified template of Annual Safety Report

    Publication | 31-01-2019

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