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Leistungen
Project website online
An in-depth examination of the previously identified ethical, legal and regulatory framework in the context of the solutions being developed by CYLCOMED.
CMD Risk Management Methodologies (öffnet in neuem Fenster)Report on current risk management methodologies and elicits challenges and requirements for next-generation risk management tools.
Pilot planning and evaluation strategy incl. clinical trial submission package (öffnet in neuem Fenster)Report describing the details of the use cases and the design of each pilot (architectural design, expected integration with CYLCOMED toolbox), and the expected evaluation strategy.This will include a clinical trial submission package (Study Protocol, Registry in clinicaltrials.gov, Ethics approval for clinical sites prior to respective enrollment of patients)
Baseline analysis, requirements and specifications (öffnet in neuem Fenster)Report listing all the defined requirements for the CYLCOMED toolbox
Requirements and specifications consolidation (öffnet in neuem Fenster)Report consolidating the requirements for the CYLCOMED toolbox
Analysis of Ethical, Legal and Data Protection Frameworks (öffnet in neuem Fenster)An overview of the relevant applicable ethical, legal and regulatory frameworks, with a particular focus on data protection, privacy and cybersecurity in the context of CYLCOMED.
Guidance improvement - intermediate report (öffnet in neuem Fenster)Report listing the guidelines for the extension of the current baselines from a technical and organizational perspective
CYLCOMED Risk benefit schemes and Management Tool Initial Release (öffnet in neuem Fenster)Report on the initial implementation and validation of risk benefit schemes and the risk management tool
First version of the DMP of CYLCOMED.
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