Suchergebnisse

This document was developed to provide a standard operating procedure (SOP) on clinical data processing for creating virtual cohorts for in-silico models. The SOP is designed for SIMCor partners as well as for the scientific community. Hence, it formulates procedures and workflows for the processing of clinical data (in particular, imaging data) in the view of generating virtual cohorts. Given the heterogeneity of data, general recommendations are provided, rather than precise steps, with specific illustrations based on the SIMCor use case: transcatheter aortic valve implantation (TAVI). Standards and guidelines for data quality, data formats and data exchange were applied, when they existed. Confronting the current workflow with the evolving practice as the project continues may lead to updates, thus subsequent iterations are foreseen. ; SIMCor (In-Silico testing and validation of Cardiovascular IMplantable devices) has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 101017578.

The purpose of the document is to provide recommendations on the formatting, organization, and content of reports describing in-silico modelling and results in the field of computational fluid dynamics (CFD) and finite element analysis (FEA) for medical device regulatory submissions. Besides that, those recommendations also aim at helping clear and transparent communication about computational studies in interdisciplinary teams and at improving reproducibility of studies. This document has been built on published recommendations of various organizations concerned with modelling and simulations and V&V activities for health products, such as the Committee on Credible Practice of Modelling & Simulation in Healthcare, V&V sub-Committees of the American Society of Mechanical Engineers (ASME), the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). In addition, even though they are not specific to human health and health products, recommendations from NASA have also been accounted for as they provide a high-quality framework for CM&S in potentially high-risk applications1,2. The structure of the document has been built on the FDA guidance for reporting computational modeling studies in medical device submissions3, mainly. ; SIMCor (In-Silico testing and validation of Cardiovascular IMplantable devices) has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 101017578.