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CORDIS - Risultati della ricerca dell’UE
CORDIS

Personalised response monitoring in oncology: co-creating clinical trials in advanced breast cancer

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

Information package (si apre in una nuova finestra)

Compliance with GDPR and Ethics requirements will be ensured for all activities at each partner, including radiation risk and AI-related issues. This will be approached by exchanging with each partner information on the following issues and finally checking their corresponding activities:1) Procedures and criteria for recruitment in clinical trials and in social science studies; 2) Detailed information on informed consent procedures and compliance with General Data Protection Regulation [EU] 2016/679; 3) Detailed information on procedures for acquiring the consent of adults unable to provide consent; measures to assess, control and inform on radiation risks; 4) Details regarding ethics approval and the approval of the Data Protection Officer; 5) how the risks for the human subjects associated with the termination of the research program would be addressed; 6) Procedures for data collection, storage, protection, retention and destruction and confirmation that they would comply with national and EU legislation (General Data Protection Regulation [EU] 2016/679).

Submission package (si apre in una nuova finestra)

Submission package containing the final version of the clinical trial protocol as submitted to regulators, a registration number of the clinical trial in a WHO or ICMJE-approved registry (e.g. the EU Clinical Trials Register) and approvals from ethics committees and national competent authorities

Project Repository (si apre in una nuova finestra)

1. To ensure the operational and scientific coordination and management of the project on behalf of the consortium as well as project progress, including financial management. 2. To ensure timely reporting to the EC. RSD is responsible for the overall administrative and financial management of the project. Tasks include contractual and financial issues, IP management, daily management, and quality assurance, as well as monitoring and following up on the progress of the WPs to ensure that deadlines are met for the project to stay within budget and on schedule

Redcap database for T4.1 (si apre in una nuova finestra)

Redcap database setup and ready

Website and social media accounts launched (si apre in una nuova finestra)

Website and social media accounts public.

Project Handbook (si apre in una nuova finestra)

The coordinator will develop a dedicated project management handbook, which describes the route for implementing the project and provides tools and templates for measuring project progress.

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