Integration of heterogeneous Data and Evidence towards Regulatory and HTA Acceptance

Informations projet

IDERHA

N° de convention de subvention: 101112135

DOI 10.3030/101112135

Date de signature de la CE 10 Mai 2023

Date de début 1 Avril 2023

Date de fin 31 Mars 2028

Financé au titre de

• Health

Coût total € 36 181 150,86

Contribution de l’UE € 23 032 209,61

Coordonné par

FRAUNHOFER GESELLSCHAFT ZUR FORDERUNG DER ANGEWANDTEN FORSCHUNG EV
Germany

Livrables

Documents, reports (5)

Data Management Plan (1)

The Data Management Plan (DMP) will be a living document and evolve during the lifetime of the project in order to describe the data management life cycle for the data that is currently available (retrospective data) and the data to be collected (prospective data), processed and/or generated by IDERHA project and how to provide FAIRfication for research data. It will also cover data flows within consortia, GDPR, data privacy and security and long-term sustainability.

Clinical observations study initiation package

At the initiation of the clinical observational study, a study initiation package will be compiled that will include clinical study registration, final version of the study protocol as well as regulatory and ethics approvals.

Data and analysis platform architecture (incl. different data sources and data types support) (1)

Report on the architecture principles, blueprint, governance, standardization, and interfaces that will guide the implementation, adoption, and integration. Describes the architecture for the different platforms and their interconnection in area of care and research

Report on Global Regulatory Best Practices Analysis

Inventory and analysis of current assessment approaches and policies of evidence generated from heterogeneous health data to identify 1) potential best practices for broader adoption, and 2) current gaps in policies for criteria for regulatory, HTA and payer acceptance of evidence generated using heterogeneous health care data.

Analysis of current and emerging policies for data access/sharing, research use and transparency requirements

Inventory and comparative analysis of policy and legislative enablers, disablers and gaps impacting on the scale up of health data access for evidence generation. This will consider EU level instruments, selected national and health care center examples, and consider impacts from the perspective of different data stakeholders.

Websites, patent fillings, videos etc. (1)

Description of Communication and dissemination tools

Website, newsletters, social media channels, video, animation, infographic, webinars, press releases, visual identity, template for Word and PowerPoint, style guide etc.