Information CCMO due to coronavirus outbreak

On this page you will find our information following the coronavirus outbreak (COVID-19).

Conditions for (re)starting clinical research

Certain conditions apply to the (re) start of clinical research:

  • This document contains the conditions for the (re)start of studies in clinical research units.
  • The conditions for the (re)start of other clinical research are set out in this document from the Dutch Health and Youth Care Inspectorate.

Recommendations for the conduct of clinical research

This document provides recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus.

Accelerated procedure (fast track) review of research files

CCMO allows an accelerated review (fast-track procedure) of research files concerning studies on COVID-19 within the authorisation of CCMO. Along with CCMO as a review committee, accredited MRECs and the competent authority have also set up fast-track procedures for the accelerated review of research into the occurrence and/or treatment of COVID-19.

Emergency regulation for authorisation of research into COVID-19-targeted gene therapy or medicinal product containing GMO

Due to the exceptional circumstances, the Ministry of Infrastructure and Water Management has decided to accelerate the authorisation procedure for research into gene therapy or a medicinal product containing a genetically modified organism (GMO), that is aimed at combating COVID-19. For more information we refer you to the following page.

Digital submission only

You must submit all documents digitally until further notice. CCMO letters and CCMO decrees will temporarily not include a 'wet signature'.

Accessibility of CCMO

CCMO will not be directly accessible by telephone for the time being. For more information on what to keep in mind when contacting us we refer you to the following page.