The FACILITATE project is executed through delivery of 7 individual Work Packages (WPs) and one supplementary WP8
Work Package 1
WP1 relates to Project Management and Administration. It will ensure that all the project objectives, tasks and deliverables are met on time and to budget. It will also help manage any risks on the project to ensure that the important objectives for patients and other stakeholders are delivered on.
Work Package 2
WP2 concerns the Legal and Data Privacy Framework. It will develop the guidance documents necessary for primary and secondary use of patients’ clinical data in compliance with GDPR – it must include privacy notices, consenting practice, rights management for re-use of the data, clauses for investigators contracts. WP2 members will engage with regulators, patient groups, data protection experts to ensure objectives of this WP are met.
Work Package 3
WP3 is closely linked with WP2, but looks at the Ethics, Standardization, and Regulatory framework. This WP team will review and integrate technical and regulatory standards proposed by WPs 1 and 2 and provide recommendation aligned with the patients’ voice – new standards will be developed if necessary and approval of these standards sought from the regulators.
Work Package 4
WP4 concerns the Technical Platform Structure/Design that will be used to return data to patients and the associated requirements. It will develop a technology framework based on existing or new technologies and identify any potential technical issues. It will set up the process to be used in WP5.
Work Package 5
WP5 relates to the Technology Framework and Interoperability Solutions. It will deploy a working prototype process to test that it is viable, to suggest overall direction, and to provide feedback (a working prototype demonstrating the feasibility for study participants to get access to their clinical study data).
Work Package 6
WP6 relates to Communication and Dissemination & Stakeholder Engagement (see stakeholder pages for details of stakeholders involved). It will establish a FACILITATE project website and all appropriate tools for communications purposes to ensure awareness and updates as the projects develops. It will establish and implement a communication structure, conduct surveys with patients, Health Care providers, regulators etc to get their input and will establish and organise dissemination of the project results.
Work Package 7
WP7 relates to Business Exploitation and Sustainability. It will establish a robust business plan to ensure sustainability and implementation of the project results. It will execute the business plan, including marketing of the project deliverables to the relevant end-users (all stakeholders as previously described).
Work Package 8
WP8 concerns the ‘ethics requirements’ that the project must comply with under IMI2 JU rules.