Investigators
- Guide to the review procedure
- E-learning
- Legal framework for medical scientific research
- Your research: Is it subject to the WMO or not?
- Laws
- Decrees and ministerial regulations
- CCMO directives
- Codes of conduct
- WMO: protection human subjects central
- Types of research
- Research with a medicinal product
- Research with a medical device until 26 May 2021
- Research with a medical device from 26 May 2021
- Vaccine research
- Research on cell therapy
- Research on gene therapy or medicinal product with GMO
- Research with subjects under the age of 16 years
- Research with incapacitated subjects
- Research with gametes and/or (leftover) embryos and the foetus
- Research with ionizing radiation
- Non-WMO research
- Other types of research
- Standard research file
- A. Correspondence
- B. Forms
- C. Protocol
- D. Product information
- E. Information research subjects
- F. Questionnaires etc.
- G. Insurances
- H. CVs
- I. Participating centres
- J. Financial compensation
- K. Other documents
- L. Safety information
- M. Progress and results
- Primary submission to the review committee
- Review committee: accredited MREC or CCMO?
- Multicenter research
- How to submit
- Timelines reviewing committee
- Procedure fast-track review by CCMO as review committee
- Research with a medicinal product: extra review competent authority
- Definition of research with a medicinal product
- Competent authority: CCMO or Ministry of Health, Welfare and Sport?
- Registration in EudraCT database
- Primary submission to the competent authority
- Timelines competent authority
- Changes to documents during the primary submission
- During and after the research: notifications to the competent authority
- Research with a medicinal product: Voluntary Harmonisation Procedure (VHP)
- Appeals and objections
- Appealing to a decision by an MREC
- Objection to a decision by the CCMO
- During and after the research
- Starting date
- Changes to the research file (amendments)
- SAEs, SUSARs and SADEs
- Progress report
- Development Safety Update Report
- Suspension, premature termination or end of study
- Summary clinical trial results
MRECs
- Accredited MRECs
- Central Committee on Research Involving Human Subjects (CCMO)
- CMO region Arnhem-Nijmegen
- Foundation Beoordeling Ethiek Biomedisch Onderzoek
- Independent Review Board Nijmegen
- Medical Research Ethics Committees United (MEC-U)
- MREC Academic Hospital Maastricht / University Maastricht
- MREC Academic Medical Center Amsterdam
- MREC Brabant
- MREC Erasmus Medical Center Rotterdam
- MREC Isala clinics Zwolle
- MREC Leiden The Hague Delft
- MREC Máxima Medical Center
- MREC Netherlands Cancer Institute - The Antoni van Leeuwenhoek Hospital
- MREC University Medical Center Groningen
- MREC Utrecht
- MREC VU university medical center
- MREC Wageningen University
- MREC Z
- RTPO
- Supervision
About the CCMO
- Tasks
- Independence
- Contact
- Suggestions and complaints
- Committee members
- Prof. J.M.A. (Joop) van Gerven
- Prof. M. (Michaël) Boele van Hensbroek
- Prof. J.J.M. (Hans) van Delden
- Prof. J.H.L.M. (Hans) van Bokhoven
- Prof. J.G. (Anske) van der Bom
- Prof. J.J. (Jan) van Busschbach
- J.H.H.M. (Jo) Dorscheidt, PhD
- Prof. A.C.G. (Toine) Egberts
- Prof. W.E. (Wim) Fibbe
- Prof. J.B.A.G. (John) Haanen
- W.G. (Erwin) Ista, PhD
- Prof. C.A.J. (Catherijne) Knibbe
- Prof. J.G.W. (Jos) Kosterink
- J.A. (Jolande) Land, PhD
- Prof. J.J.B. (Jan) van Lanschot
- M.N.C.M. (Marcel) Mutsaerts, MD
- B. (Bastiaan) Nuijen, PhD
- Prof. C.N.L. (Chris) Olivers
- M.C. (Corrette) Ploem, PhD
- Prof. S. (Sjoerd) Repping
- Prof. G.A.P.J.M. (Gerard) Rongen
- Prof. F.R. (Frits) Rosendaal
- Prof. D. (Dick) Tibboel
- Prof. S. (Suzanne) van de Vathorst
- Prof. R.M. (Ruud) Verdaasdonk
- Prof. H. (Hester) Vermeulen
- H.C.R.M. (Henri) de Wijkerslooth de Weerdesteijn, LLM
- Staff
- Executive director
- CCMO Office
- National Clinical Trial Office
- Team Operational Management
- Observer
- Meeting dates
- Documents
- CCMO regulations and complaints procedure
- CCMO memoranda
- ToetsingOnline
- CCMO register
- Information CCMO due to coronavirus outbreak
Human subjects
- Medical scientific research
- Types of research
- Becoming a research subject
- Things to bear in mind
- Payment
- Participating in multiple studies
- Your data
- Your rights and obligations
- Your own decision
- Information and questions
- Time to reflect
- Insurance for research subjects
- Stopping
- Your obligations
- Why participate in research?
- Informed consent
- Research subjects aged 16 and older
- Children and youngsters
- Incapacitated adults
- Research subjects and the law
- Complaints