ECRAID-Prime deliverable 4.1: Data Management Plan, Horizon Europe template

This Data Management Plan (DMP) describes the data management related tools, processes and procedures of ECRAID-Prime. It has been developed based on the ECRAID-Prime proposal and the specifications obtained during the information gathering and analysis process. The DMP is intended to serve as the basis for all further data management related activities within ECRAID-Prime. The DMP is designed to ensure optimal collection, processing, storage, and dissemination of the ECRAID-Prime trial’s data, including making it as compliant as possible with FAIR principles, by - for example - proposing secure methodologies for data collection and storage, promoting interoperability through data and metadata standards, and facilitating data sharing. The DMP describes the elements of the data management policy that will be used by beneficiaries for all the datasets that will be generated by the project. Implementation details that apply to the implementation of the trial will be documented separately in an implementation DMP (e.g. procedures related to eCRFs development, randomisation, reports, data mapping and dataset delivery; and policies for database validation and monitoring). Data management activities will be performed within WP4 by the UMCU data management department of the Julius Center. This department will also carry out most of the data management activities within the EU Horizon 2020 funded ECRAID-Base project (grant agreement 965313). In order to take advantage of synergies and avoid duplication, data management activities between the two projects will be linked as much as possible. This first draft version of the DMP reflects the current knowledge of the data management requirements for ECRAID-Prime. At this stage there are no final study protocols available and therefore a lot of the details of the planned trial are lacking. The DMP is conceived as a living document, however, and as more details become available about the trial within the project, the DMP will be updated. It is therefore expected that several subsequent versions of the DMP will be produced during the project’s lifetime.