Characterisation of Drug Role

This data element is used to enter the characterisation of the drug role as provided by the primary reporter, and if this information is not available, the information provided by the sender. All spontaneous reports contain at least one suspect drug (see section 3.3.1). When the reporter suspects an interaction with another drug, "interacting" should be selected for all drugs suspected of the interaction. When an interaction with food or a non-medicinal product is suspected, "interacting" should be selected for the suspect drug. For assessment purposes, all drugs involved in an interaction are considered suspect drugs. For example, the type of interaction, such as drug interaction, food interaction, or alcohol interaction, should be entered using the appropriate MedDRA LLT code in the adverse reaction/event in section E.i along with the adverse event resulting from the suspected interaction. "Not administered" can only be used in the following two situations: - Clinical trials: when an adverse reaction occurs before administration of the investigational medicinal product, such as during the screening period and wash-out period after signing the informed consent, these adverse reactions are generally reported in accordance with study procedures. In this case, in section G, only G.k.1, G.k.2, and G.k.8 are completed. Information on the suspected cause of the adverse reaction should be entered in the narrative field in H.1. The reporter's opinion should also be