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CORDIS - Forschungsergebnisse der EU
CORDIS

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

CORDIS bietet Links zu öffentlichen Ergebnissen und Veröffentlichungen von HORIZONT-Projekten.

Links zu Ergebnissen und Veröffentlichungen von RP7-Projekten sowie Links zu einigen Typen spezifischer Ergebnisse wie Datensätzen und Software werden dynamisch von OpenAIRE abgerufen.

Leistungen

Information package (öffnet in neuem Fenster)

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 (öffnet in neuem Fenster)

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 (öffnet in neuem Fenster)

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 (öffnet in neuem Fenster)

Redcap database setup and ready

Website and social media accounts launched (öffnet in neuem Fenster)

Website and social media accounts public.

Project Handbook (öffnet in neuem Fenster)

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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