The Netherlands’ Central Committee on Research Involving Human Subjects (CCMO) announced the availability of fast-track approval procedures for clinical trials related to the development of vaccines for COVID-19. To make use of this procedure, please contact CCMO via ccmo@ccmo.nl or telephone number 070 340 6700.

In addition, CCMO issued guidance in response to inquiries regarding the conduct of clinical trials during a COVID-19.

Meditrial manages several studies in the Netherlands and has direct connections with Investigators, hospitals  and local Ethics Committees (MREC). Please feel free to contact us for advice and support.

CCMO allows for exceptional amendments to or deviations from the study protocol without prior approval, as well as delivering study drugs directly to trial subjects. Additionally, CCMO provides indications on cases when the review committee (CCMO or accredited MREC) is required.

Amongst others, all the deviations from the protocol and standard procedures should be made in writing. Due to urgent safety measures a deviation from the protocol or a protocol modification can take place without prior approval by the review committee.

In case the trial is partially suspended, it must be immediately reported to the review committee. If the trial is prematurely terminated, it has to be reported as soon as possible to the review committee, but at the latest within 15 days.

The procedure for submitting a substantial amendment to the review committee has not been changed. In emergency situation when the fast-track assessment procedure is needed, the review committee should be contacted regarding the procedure to be followed.

For initial applications and substantial amendments, the obligation to submit a cover letter with wet signature to the review committee and/or the competent authority has been suspended. Instead, the digital or scanned signature of the applicant is sufficient.

The procedure for notifications to the Dutch competent authority, both during and after the study, has not been changed.

Recommendations for the conduct of clinical research during COVID-19 can be found here.

Information CCMO due to coronavirus outbreak can be found here.

Meditrial can help – Contact us for immediate support

Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:

Contact Meditrial for immediate assistance in Europe or the US. Free Helpline +1-800-901-4286 helpline@meditrial.net