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Practical links with regards to clinical research:


Dutch competent authority: Central Committee on Research involving Human Subjects (CCMO)
    
Web portal of the CCMO to be used for submission and approval of medical-scientific research

Dutch Medicines Evaluation Board (CBG)

Dutch inspection of Health Care (IGZ)

EudraCT database

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals in Human Use (ICH-GCP)

US Food and Drug Administration (FDA)

Association for Clinical Research Professionals (ACRP)

European Medicines Agency (EMEA)

Accreditation ICH-GCP course GAIA-system

CTS PROX B.V.

Across Alliance


Documents:

Dutch ICH-GCP booklet

Declaration of Helsinki (English version, October 2008)

Dutch law of medical-scientific research in humans (version 1st of March 2006)

Instruction manual European Clinical Trial Directive

 
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