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