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D2. IMDD template

Form | 14-12-2020

K3. Template Clinical Trial Agreement for investigator-initiated research for use with VGO

Form | 30-11-2020

K3. Template Clinical Trial Agreement for industry-sponsored research for use with VGO

Form | 30-11-2020

Flowchart Adverse events research with a medical device

Publication | 06-10-2020

E1/E2. Template Subject Information Sheet (English)

Form | 03-09-2020

E1/E2. Template Subject Information Sheet (Dutch)

Form | 03-09-2020

Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus

Publication | 25-08-2020

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

Publication | 12-08-2020

Review of a clinical investigation with a medical device – guidance document for MRECs

As of 26 May 2021, the EU Medical Device Regulation (MDR) will be applicable. This guidance sets out the implications for the ...

Publication | 10-08-2020

I2. Site Suitability Declaration (Verklaring Geschiktheid Onderzoeksinstelling, VGO)

Form | 03-07-2020

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