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Investigators
Help-me-on-my-way!
Medical/scientific research and the WMO
Your research: does it fall under the WMO
Non-WMO research
WMO: protection human subjects central
Research protocol
Patient information
Consent
Independent expert
Insurance
Research data, coding and privacy
Primary submission to the reviewing committee
Reviewing committee: CCMO or MREC
Multicenter research
How to submit & addresses
Timelines reviewing committee
Appeals and objections
Research with a medicinal product & extra review competent authority
Definition of research with a medicinal product
The competent authority: CCMO or Ministry of Health, Welfare and Sport
EudraCT
Primary submission to the competent authority
Timelines competent authority
During and after the research & the competent authority
Voluntary Harmonisation Procedure
Standard research file
During and after the research
Starting date
Changes to the research file (amendments)
SAEs, SUSARs and SADEs
Progress report
Safety report for research with a medicinal product
End of study
Study results
Types of research
Research with a medicinal product
Research with a medical device
Vaccine research
Research on cell therapy
Research on gene therapy/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
Other types of research
Population research
Questionnaire research
File research
Research with ionizing radiation
Useful links
MRECs
Accredited MRECs
Accreditation
Conditions
Request
Time line
Preservation
Withdrawal
Term in office
Registration of new members of the MREC
Entering decisions
Oversight
Accredited MRECs and the modified Embryo Act
Accredited MRECs and multicentre research
Accredited MRECs and the Voluntary Harmonisation Procedure (VHP)
Human subjects
Medical research
Becoming a research subject
To bear in mind
Compensation
Participating in more than one research
Your data
Your rights and obligations
It's your decision
Information and questions
Time to reflect
Insurance for research subjects
Withdrawal from research
Your obligations
Why participate in research?
Informed consent
Adults
Minors
Incapacitated subjects
Complaints
Legislation for research subjects
Types of research
Library
Legal framework
CCMO Directives
National legislation (Dutch)
Wijziging Verzekeringsbesluit met ingang van 1 juli 2015
Verruiming mogelijkheden medisch-wetenschappelijk onderzoek met minderjarige en wilsonbekwame proefpersonen
Evaluations of legislation (Dutch)
International legislation
European regulation
Europese verordeningen medische hulpmiddelen en in-vitro diagnostica
Algemene Verordening Gegevensbescherming
Codes of conduct
Standard research file
News archive
Documents for MRECs
Publications of the CCMO
jaarverslagen
Other relevant publications
CCMO
Tasks
Independance
Contact
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Members
Secretariat employees
Publications
Vacant positions
CCMO websites
Onderzoekswijs
ToetsingOnline
CCMO-register
To bear in mind
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Becoming a research subject
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