Deliverables
The report will provide identification of the best certification strategy for each of the initial collections This will be reviewed against best practices also in other fields but also by discussing specific issues regarding regulatory aspects In addition a general certification strategy that could be effective for all validation data collections will be identified and discussed In parallel methods to deal with data uncertainty and missing data in validation collections will be described and analysed using existing data collections
The report will contain an analysis of the data collections FFRValid HFValid TBValid and StentValid with respect to their intended use and a description of the way they are published In addition a general characterisation of data collection types intended use and the implication for storage usability searchability and certification will be defined and published Where possible this report will also contain datasets of other partners who are contributing early collections in termsof requirements and specific guidelines The analysis will also consider the ethical societal and regulatory requirements
This deliverable maps the relevant ethical and legal requirements that partners should take into account from the early stages of the project
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Publications
Author(s): Flora T. Musuamba, Ine Skottheim Rusten, Raphaëlle Lesage, Giulia Russo, Roberta Bursi, Luca Emili, Gaby Wangorsch, Efthymios Manolis, Kristin E. Karlsson, Alexander Kulesza, Eulalie Courcelles, Jean-Pierre Boissel, Cécile F. Rousseau, Emmanuelle M. Voisin, Rossana Alessandrello, Nuno Curado, Enrico Dall’ara, Blanca Rodriguez, Francesco Pappalardo, Liesbet Geris
Published in: CPT: Pharmacometrics & Systems Pharmacology, 2021, ISSN 2163-8306
Publisher: Nature Publishing Group
DOI: 10.1002/psp4.12669