Information CCMO due to coronavirus outbreak

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.

Contact with CCMO on fast-track reviews

Investigators submitting studies with unauthorised COVID vaccines and multinational studies with therapeutic medicinal products for the treatment of COVID that have been submitted via CTIS may contact CCMO at ccmo@ccmo.nl to discuss possibilities for a fast-track review.

For a fast-track review by the competent authority of research files on COVID-19, please send a message to bi@ccmo.nl  or info-bi@cbg-meb.nl  stating: 'FAST TRACK COVID-19'.

Recommendations vaccine studies

In the case of studies with unauthorised COVID-19 (booster) vaccines, the investigator is requested to include the following information in the research file:

• the possibility of obtaining a Ctb/DCC based on the study vaccination;
• the possibility for study participants to (request unblinding and) opt for a regular (booster) vaccine once this becomes available to them;
• the methodological consequences of administering a regular vaccine during the study;
• information about possible interaction between the study vaccine and a regular vaccine;
• whether and how participants will be asked to continue to participate in the study after receiving the regular vaccination, in order to obtain information on vaccine combinations.

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

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