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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


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