Lead safety assessing Member Statemeans the safety assessing Member State, which coordinates the safety assessments for different active substances in a clinical trial or for several clinical trials, performed by several safety assessing Member States.
Mono-national active substancemeans an active substance, which is used in an investigational medicinal product in clinical trial(s) authorised in only one Member State.
Multi-national active substancemeans an active substance, which is used in an investigational medicinal product in clinical trial(s) authorised in more than one Member State.
Multi-national clinical trialmeans a clinical trial for which the sponsor submitted an application dossier to more than one Member State through the EU portal.
New active substance for safety cooperationmeans an active substance, which has not been previously used in an investigational medicinal product in any clinical trial authorised in the Union under Regulation (EU) No 536/2014, and therefore does not have an assigned safety assessing Member State.
Reference safety informationmeans the safety information contained in the latest approved version of the clinical trial dossier, which serves as the basis to determine the expectedness of an adverse reaction by the sponsor.
Safety assessing Member Statemeans the Member State that assesses the information submitted as suspected unexpected serious adverse reactions in accordance with Article 42 of Regulation (EU) No 536/2014, and the information contained in annual safety reports submitted in accordance with Article 43 of that Regulation, for clinical trials involving investigational medicinal products that contain the same active substance, regardless of the pharmaceutical form and strength or indication investigated and regardless of whether they are used in one or several clinical trials managed by the same or different sponsors.
Safety concern in relation to an investigational medicinal productmeans information on the safety of the investigational medicinal product with potential negative impact on its benefit-risk ratio or with a public health implication.
Screening of suspected unexpected serious adverse reactionsmeans the systematic identification of suspected unexpected serious adverse reactions that require an assessment leading to a decision on the need to notify the reporting Member States and Member States concerned.