This document describes the data standards designed for the clinical studies of the IDEA-FAST project with respect to sleep/fatigue/activities of daily living (ADL) and the ontology for sensor measurements. It provides examples and guidelines for standardising clinical data and device data collected by the IDEA-FAST project. The data standards defined in this document are based on the Study Data Tabulation Model (SDTM) developed by the Clinical Data Interchange Standards Consortium (CDISC). This document (deliverable D5.4) was intended to be a public version of deliverable D5.3, with any confidential information removed. However, on review, it was decided that the full content of D5.3 can be made publicly available. Thus D5.4 is essentially the same document as D5.3.
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