This part of the application form relates to aspects of medical ethical assessment by the CCMOCentral Committee on Research involving Human Subjects and Ministry of VWSMinistry of Health, Welfare and Sport .
The CCMO will assess the research proposal according to the criteria of the Medical Research Involving Human Subjects Act (WMOMedical Research Involving Human Subjects Act ). The standard research file provides an overview of all documents that must be submitted for assessment to the CCMO and the Ministry of VWS. The CCMO website (http://www.ccmo.nl/en/standard-research-file) provides extensive instructions in the document entitled ‘Standard Research File, with commentary’. The website also provides templates for the cover letter, the research protocol, the Investigational Medicinal Product Dossier (IMPDInvestigational Medicinal Product Dossier ), the information letter and the clinical trial agreement, for example. To verify quickly and efficiently whether the research file is complete, these documents should be submitted in the order indicated.
At the CCMO, your application should preferably be submitted in digital form. Applications may also be submitted on paper (singular, unbound). For the competent authority, the Ministry of Health, Welfare and Sport (VWS), digital submission is mandatory.