Investigators
- Guide to the review procedure
- 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
- Primary submission to the review committee
- Review committee: accredited MREC or CCMO?
- Multicenter research
- How to submit
- Timelines reviewing 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)
- 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
- 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
- Types of research
- Research with a medicinal product
- Research with a medical device
- 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
MRECs
- Accredited MRECs
- Academic Hospital Maastricht / University Maastricht
- Academic Medical Center Amsterdam
- Central Committee on Research Involving Human Subjects (CCMO)
- CMO region Arnhem-Nijmegen
- Erasmus Medical Center Rotterdam
- Foundation Beoordeling Ethiek Biomedisch Onderzoek (BEBO)
- Independent Review Board Nijmegen
- Isala clinics Zwolle
- Leiden University Medical Center
- Máxima Medical Center Veldhoven
- MEC-U
- MREC Brabant
- MREC Southwest Holland
- MREC Twente
- MREC Utrecht
- MREC Z
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Amsterdam
- RTPO Leeuwarden
- University Medical Center Groningen
- VU university medical center
- Wageningen University
- Supervision
About the CCMO
- Tasks
- Independence
- Contact
- Committee members
- Prof dr JMA (Joop) van Gerven
- Prof dr M (Michaël) Boele van Hensbroek
- Prof dr JJM (Hans) van Delden
- Prof dr ir JHLM (Hans) van Bokhoven
- Prof dr J (Johan) Denollet
- Mr dr JHHM (Jo) Dorscheidt
- Prof dr ACG (Toine) Egberts
- Prof dr WE (Wim) Fibbe
- Prof dr JBAG (John) Haanen
- Prof dr M (Mariët) Hagedoorn
- Mr SJE (Liesbeth) Horstink-von Meyenfeldt
- Dr WG (Erwin) Ista
- Prof dr CAJ (Catherijne) Knibbe
- Prof dr JGW (Jos) Kosterink
- Dr JA (Jolande) Land
- Prof dr JJB (Jan) van Lanschot
- Dr B (Bastiaan) Nuijen
- Mr dr MC (Corrette) Ploem
- Prof dr S (Sjoerd) Repping
- Prof dr GAPJM (Gerard) Rongen
- Prof dr FR (Frits) Rosendaal
- Prof dr D (Dick) Tibboel
- Prof dr S (Suzanne) van de Vathorst
- Prof dr H (Hester) Vermeulen
- Prof dr ir HCW (Riekie) de Vet
- Mr HCRM (Henri) de Wijkerslooth de Weerdesteijn
- Staff
- Executive director
- CCMO Office
- National Clinical Trial Office
- Team Operational Management
- Observer
- Drs S (Sytske) de Jong
- Meeting dates
- Documents
- CCMO regulations and complaints procedure
- CCMO websites
- Onderzoekswijs
- ToetsingOnline
- CCMO register
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