Applications for the purpose of clinical research with GMOs are made up of two separate parts as a result of the different assessment frameworks:
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The (Genetically Modified Organism) application form for the (Office for Genetically Modified Organisms)/IenW provides information needed for the authorisation by the Ministry of (Ministry of Infrastructure and Water Management).
The research file for patient-related aspects for (Central Committee on Research involving Human Subjects) should be submitted via the EU portal CTIS.