Applications for the purpose of clinical research with GMOs are made up of two separate parts as a result of the different assessment frameworks:

	Part A: Biosafety related aspects
	Part B: Patient related aspects

The GMO Genetically Modified Organism (Genetically Modified Organism ) application form for the GMO Office Office for Genetically Modified Organisms (Office for Genetically Modified Organisms )/IenW provides information needed for the authorisation by the Ministry of IenW Ministry of Infrastructure and Water Management (Ministry of Infrastructure and Water Management ).

The research file for patient-related aspects for CCMO Central Committee on Research involving Human Subjects (Central Committee on Research involving Human Subjects ) should be submitted via the EU portal CTIS.