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Overview of assessment criteria described in MDR

Publication | 15-01-2020

K3. Template Clinical Trial Agreement – non-WMO research

Form | 01-01-2020

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

Publication | 14-10-2019

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

Form | 14-10-2019

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

Form | 14-10-2019

K3. Template Clinical Trial Agreement - investigator-initiated research

Form | 20-09-2019

D2. IMDD template

Form | 20-09-2019

Standard research file Explanation

Explanation of the standard research file and the explanation of codes and document titles for digital submission.

Publication | 21-05-2019

L3. Template DSUR

Form | 31-01-2019

E1/E2. Example Subject Information Sheets

Publication | 14-01-2019

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