Timeline of data collection.
SCARRING
*This point will be checked by the healthcare team as all wounds closed and scarring is complete or before the start of radiotherapy in patients proposed for radiotherapy** Consider 6 and 12 months after healing when no radiotherapy was performed or 6 and 12 months after radiotherapyPlans for data entry, coding, security, and storage, are very strict; they include the use of trusted cloud sources and experienced partner. Processes to promote data quality were discussed and a glossary as well as a wizard will be used to help guide manual data entry where applicable. Details of data management procedures can be found in the project Data Management Plan (Deliverable D.6.8/D6.9 –sensitive/confidential level). Data will be stored in the ISO27001 certified CANKADO Software. All clinical centres received institutional security approval for data safety of the whole trial process.Data management strategy of CINDERELLA trial is planned according to FAIR (Findable, Accessible, Interoperable, and Reusable) principles. At regular intervals planned meetings with data management, information technology and data protection, and ethics board experts’ representatives from relevant stakeholders will be held. This will serve to assure that data collected and shared by the consortium members and all analysis of personal data is performed according to the appropriate legal basis (General Data Protection Regulation for the EU GDPR, and corresponding legal basis in Israel). All information, including patient’s photographs, will undergo de-identification processes and security measures as required by mentioned data protection regimes, and guidelines, as well as according to local policies and ethical sensitivities. The CINDERELLA APProach will be tested at different times and levels to check for its alignment with data protection regulation, ethical principles in usage of AI and bioethical standards/policies within the participating entities of different countries.The EU team will monitor the inclusion rate and data completion along the clinical trial timeline. Reports will be available periodically to all clinical facilities to allow to correct deviations in a timely manner.There is no direct human–AI interaction in the handling of the input data, in the sense that images to be collected as well as clinically relevant information are obtained from patients and from health professionals via the photo robot or by manual input into interfaces that do not run AI in the interaction process. Average digital skills are expected from users, but if the patient cannot document some of the data about herself, she can ask for support from family/caregiver. Regarding image capture—this will be facilitated by the automation involved, but the handling of the robot does not require advanced digital skills, nor does it imply direct human-AI interaction.