CAPABLE D7.6: Informed Patient Consent/Assent Form, Ethical Committee Approval, Training Materials, and Technical Manual for Maintenance

In this deliverable, we present the activities carried out in WP7 in preparation for the CAPABLE pilot studies. These activities include:

1. the preparation of the preliminary documentation for study authorization in compliance to the current EU regulations in terms of data protection and medical devices usage,
2. the preparation of a training plan for the users of the system and for the technical staff who will support users during the study, and
3. the definition of the policies for the maintenance of the CAPABLE software and of the devices that are needed for it to be used.

This document is organized into three Sections, each one related to the described activities. Being this a Demonstration deliverable, it includes the references to all the documentation that has been prepared during the last year of the project. The links to the available documentation are reported in the Annexes Section.