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
The conditions for the (re)start of 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.
COVID-19 research: review by an accredited MREC or CCMO
The medical-ethical review of research aimed at the development of a vaccine is reserved for the CCMO. This also includes research into a possible COVID-19 challenge model. Most of the other research is reviewed by an accredited MREC. In order to determine which committee should review your research, you can use the Committee Finder Tool.
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.
Requirement GMO clinical trial authorisation COVID-19 gene therapy or medicinal product containing GMO temporarily suspended
As a result of the European Regulation 2020/1043 that came into force on 18 July 2020, parts of the GMO (Genetically Modified Organism) legislation have been rendered inoperative. For the time being, no GMO license is required for clinical research on COVID-19. This also means that the 'Temporary regulation on divergent treatment for applications for authorisation of gene therapy in connection with combating COVID-19' has been set aside. More information can be found here.
Digital submission only
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.