CAPABLE D7.1: Study Plan, Protocols Definition, and Informed Consent/Assent Drafts
- 1. University of Pavia, Italy
- 2. University of Haifa, Israel
- 3. Istituti Clinici Scientifici Maugeri (ICS Maugeri), Italy
- 4. Netherlands Cancer Institute (NKI), The Netherlands
- 5. Universidad Politécnica de Madrid, Spain
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.
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