The overall governance structure of ImmUniverse follows a multilayer structure that includes all partners grouped in the General Assembly (GA), an Executive Project Management Team (EPMT), and a Coordination Team (CT).
The management and governance structure ensures:
- support for individual scientists for the achievement of project objectives,
- progress monitoring and control on work package level,
- coordination of project activities,
- implementation of quality control mechanisms by defining appropriate project standards,
- targeted dissemination of knowledge.
The organisational structure is adapted to the size and composition of the consortium and the tasks and duties of all partners. It has been designed to aim for a good balance of all stakeholders involved. The contractual details have been laid down in the Consortium Agreement signed by all partners at the start of the project.
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In charge of day-to-day management in ImmUniverse, the Coordination Team is responsible for the overall management of scientific results, monitoring work package progress and to carry out risk assessment and contingency planning in order to ensure a timely and accurate follow-up of the work plan. It consists of the Coordinator (Humanitas University), the Project Leader (GlaxoSmithKline Research and Development Ltd), the Project Co-Lead (Sanofi-Aventis Deutschland GmbH) as well as the Project Management Office (EURICE GmbH).
Executive Project Management Team
Composed of the Coordination Team and the academic leaders and EFPIA co-leaders of the different WPs, the Executive Management Team is responsible for the coordination of the research activities from all partners involved in the project. Further responsibilities include the driving of the overall execution of the project, alignment across all WPs, decision making on project-related matters, the set-up of procedures to identify and manage innovations developed by the consortium, and to develop a risk identification and management plan.
The General Assembly is the ultimate decision-making body in ImmUniverse composed of one representative nominated by each partner institution and responsible for fulfilling the project‘s obligations towards the IMI 2 JU.
Scientific and Ethics Advisory Board
The primary aim of the Scientific and Ethics Advisory Board is to provide feedback and advice, to help guide the strategic direction and ensure that outputs are not only of high scientific quality, but also have meaningful applicability. Furthermore, it provides advice on specific ethical, regulatory and data-sharing issues raised in the ImmUniverse project. It is divided into a Scientific Advisory Board (SAB) and an Ethics Board (EB). The appointed scientists and industry leaders have been chosen to complement the consortium‘s expertise and to maximise the benefits for the project.
Biomarker Development Board
Composed of clinicians representing the two diseases, the work packages 2, 3 and 5 as well as a statistician and biomarker specialists from EFPIA, the Board qualifies decisions and developments and monitors progress in the course of the project. The subsequent reports form a base for decision making of the Executive Project Management Team.
Patient Input Platform
Established to anchor the patient perspective in ImmUniverse, the Patient Input Platform consists of expert patients living with inflammatory bowel disease and atopic dermatitis and act as a real-life sounding board of the research and its interpretation, ethics and patient communication within and outside the project.
Effective and harmonised communication of the project is paramount in spreading the activities and results of ImmUniverse. The Communication Committee plays an important role in guiding the external communication activities, including content development and quality assurance of all communication to specific target groups, such as patients, scientific community, healthcare professionals, regulatory bodies and the general public, among others.
Data Use and Access Committee
Data generated and results produced within the project will be made available to third parties after project end through controlled access. The Data Use and Access Committee is the decision making body for this. It consists of one responsible person from each clinical recruitment centre, a representative from the data management team and a representative from the OMICS production group. This committee will be sustained beyond the funding period and will meet on demand. Primary point of contact is the coordinator.