Non-WMO research with a medicinal product, research with a medicinal product not subject to CTR
To determine if research is subject to CTR, you may use the Clinical Trial Decision Tool. The tool also shows if the trial concerned is a low-intervention clinical trial.
Research with a medicinal product that does not fall under the scope of CTR and that is initiated and/or financed by pharmaceutical companies (in which influence can be exercised on the content and/or execution of the research) must be reviewed in advance according to the review framework for non-WMO research with a medicinal product. Information about the review framework and the review procedure can be found on the website nWMO-studies (in Dutch) of the Dutch Clinical Research Foundation (DCRF). Non-interventional safety studies at the request of a European registration authority are exempt from the DCRF review framework.