NETHERLANDS: Central Research Committee announces approval fastrack for trials to develop COVID 19 vaccines
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:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US. Free Helpline +1-800-901-4286 helpline@meditrial.net
Table of Contents
Build a Defensible Clinical Evidence Strategy Under EU MDR
Build a defensible clinical evidence strategy under MDR Annex XIV, from the clinical evaluation plan to PMCF and notified body review.
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
