The IDEA-FAST datasets are expected to be heterogeneous, large-scale and highly complex. WP5 will establish the state-of-the-art data management environment to address the needs of data standardisation, integration, sharing, analysis and archive for the project. This will ensure clinical data and data collected from various digital devices generated from the project meet quality and compliance requirements, and enable WP4/7 partners to perform integrated data modelling and analysis to identify novel digital endpoints. The core data management processes are summarised in Figure 1. During the FS, ICL will work together with partners involved in data collection (WP2, WP3, WP6) and data analysis (WP4, WP7) to define clinical and device-specific data standards consisting of metadata templates, control vocabularies and data dictionaries (Figure 2). Data collected from the Feasibility Study and Clinical Validation Study will be curated against the defined standards, and then integrated across different domains (e.g. demographics, diagnosis, laboratory tests, medications), across studies and across multiple digital devices, on the data management platform for data sharing and analysis.
Objectives
O5.1 Define data management strategy for the project.
O5.2 Define data standard for clinical data and sensor measurements.
O5.3 Data harmonization of clinical and sensor measurements for analysis .
O5.4 Create a secure, fit-for-purpose, adaptable DMP for organising the curated data for analysis, accessible by multiple
users simultaneously to facilitate effective data analytics and secure storage.
O5.5 Create decentralised Access Control and data provenance mechanisms for compliance with legal and data privacy requirements (e.g. GDPR), and to ensure data integrity and security (including back-up).
O5.6 Deploy integrated data analytics pipelines for use by the consortium and for review by the EMA/HTA/FDA.
Deliverables
D5.1 Data Management Plan
D5.2 Specification of IDEA-FAST DMP
D5.3 IDEA-FAST clinical and sensor data standards including SOPs for curation and harmonization of clinical data and measurement data
D5.4 Public version of IDEAFAST clinical and sensor data standards
D5.5 DMP prototype
D5.6 DMP V1, with harmonised clinical and sensor data loaded
D5.7 DMP V2, with blockchain-based access control and data provenance system
D5.8 DMP V3, with pipelines for integrated analysis
