Project deliverable Open Access

CAPABLE D7.1: Study Plan, Protocols Definition, and Informed Consent/Assent Drafts

Sacchi, Lucia; Girani, Emanuele; Panzarasa, Silvia; Parimbelli, Enea; Quaglini, Silvana; Veggiotti, Nicole; Peleg, Mor; Ghio, Viola; Rizzo, Mimma; Tibollo, Valentina; Boekhout, Annelies; Fraterman, Itske; Ottaviano, Manuel

The aim of this deliverable is to introduce the CAPABLE evaluation plan, including the activities carried out both during the development of the system and those to be performed once the system is complete. Special attention is devoted to the clinical pilot study that will take place during the last year of the project. For this study, we provide a draft of the study protocols that will have to be presented to the Ethical Committees (EC) of the two hospitals where the studies will be performed.

This deliverable is a part of a project receiving funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 875052
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