Besides the General Assembly, the ZAPI project is globally managed by 6 committees as follow:
Roles and Responsabilities of the GENA (General Assembly) – meeting at least twice a year :
- Approves proposals for changes to Appendix 3 and 4 of Project Agreement; withdrawals from Background included; additions to Background excluded; additions to the list of Third Parties linked to a Participants;
- Completes actions and decisions required by the EPMT to administer the Project;
- Takes key decisions relating to the evolution of the Project, including entries of new parties, departures of current Participants, proposals to the IMI JU for the change of direction of the consortium, including Coordinator replacement, project termination, major changes to budget allocation or significant change of Project direction.
- Defines the desirable dissemination & awareness campaign/actions to be set up the following year (Annual dissemination plans)
Roles and responsibilities of the COT (COordination team) – meeting every month :
- Oversees the day-to day management of the project
- Ensures the overall proper running of the project, the adequate work of each management body described herein according to their role and responsibility;
- Monitors implementation of the decisions of the General Assembly and liaise with the Scientific Advisory Board
- Implements the decisions of the General Assembly which have been proposed by the EPMT (Executive Project Management Team) and overseeing the work of the EPMT in accordance with the provisions of WP6;
- Support the EPMT meetings from a scientific perspective and facilitates the decision-making-process with respect to associated tasks and any potential conflicts within the EPMT or in Work Packages.
- Monitors the compliance by Participants with their obligations under the Grant Agreement and this Project Agreement, in particular obtaining and disseminating throughout the consortium information on administrative steps, and at the appropriate time, fulfilling the necessary management tasks requested by IMI Joint Unit in order to proceed to certificates on financial statements; and
- Ensures that each Participant is in a position to accede to the Grant Agreement and accept its associated special clauses by updating the Participants as to the progress of, and being able to comment on the content of, the Grant Agreement negotiations and any Grant Agreement amendments.
Roles and responsibilities of the PMO (Project Management Office) – meeting every month:
- Supports the successful implementation of this Project on a scientific, financial and management level as outlined in WP6.
- Ensures that timelines and details of tasks requested by IMI Joint Unit officers are clearly disseminated throughout the consortium in a timely manner (cost statements, ensuring compliance with the Project Agreement, scientific reports, ethical issues).
- Advises EPMT on general Project issues, including knowledge and dissemination activities regarding the Project during the Project, receive all requests for Access Rights to Background and/or Foreground which a Participant may wish to make, and forward, as appropriate, to the concerned Participant.
- Ensures effective communication between Partners to support sharing best practice, maximise synergies and prevent duplication.
- Develops and implement dissemination plans and communication strategy.
- Transmits to the Coordinator the periodic cost statements from Beneficiaries and EFPIA participants
- Supports the EPMT in their duties.
- Reviews progress of Project against project plans and budget, manage the risk mitigation plans and decision logs and prepare summary materials for presentation to the General Assembly for endorsement;
- Ensures the scientific progress of the work and the collaboration and exchanges amongst WPs, ensure the full integration and coordination of the research teams;
- Ensure effective communication between WPs with regards to project progress, best practice and harmonisation and validation across teams;
- Suggest changes to project plans, budget allocation, risk mitigation plans for endorsement by the General Assembly;- Ensures the annual plans are approved by the General Assembly, which will define the desirable dissemination and awareness campaign/actions to be set up for the following year (“Annual Dissemination Plans”);
- Ensures the organisation of regular meetings between the WP members and for the whole consortium, to ensure collaboration between the participants, adequate flow of information within the consortium and clarification of any potential overlaps and interdependencies;
- Ensures a smooth flow of information within the consortium as regards to the transmission of any documents and information connected with the Project to and between the Participants concerned;
- Prepares and reviews the project activity reports (including management and financial reports), risk management procedures, quality assurance plans, prior to submission to the IMI Joint Unit;
- Prepares reports to be approved by the General Assembly prior to submission to the IMI Joint Unit by the Coordinator. This also encompasses the preparation of periodic activity reports, periodic management and financial reports, periodic Certificates on Financial Statements, according to the rules detailed in the Grant Agreement;
- Recommends changes in project direction and risk management as appropriate to be endorsed by the General Assembly for approval;
- In support to the Ethics Governance Team, ensures that all Participants adhere to ethical rules, as foreseen by the European and National legislations, collect all necessary data and transmit them if needed to the Ethics Governance Team for advice and/or to the IMI Joint Unit;
- Reports to the General Assembly on any issue arising in the consortium or with a Participant;
- Prepares the agenda for and take minutes of the General Assembly for distribution by the Coordinator;
- Lists on a regular basis the Foreground generated by the Project and includes details on them on the yearly activity report as well as the protection actions that have been taken to ensure future exploitation;
- Ensures that all communication related to any Foreground, Publication, results or dissemination tools arising from the Project mentions that the IMI Joint Unit provided financial support;
- Solves any dispute arising amongst the consortium regarding ownership of Foreground, Access Rights to Background, Foreground or Sideground or bilateral side agreements amongst the Participants before escalation to General Assembly; and
- Ensures the use of project communication and management tools by all Participants in order to ensure operational consistency and communication across all Participants/Work Packages.
The SAB (Scientific Advisory Board) – meeting at least every year: provides the General Assembly with external advice concerning scientific aspects of the Project;
The ESAG (External stakeholder Advisory Group) - meeting at least every year: provides overall support to the strategic activities of the consortium, position the consortium as a thought leader in the field, and to ensure appropriate alignment and connection to broader strategic discussions, themes and other initiatives
The EGT (Ethics Governance Team) - meeting at least every year: provides advice related to the ethical issues: access, linkage, processing and analysis of patient level data, including adherence to good epidemiological practice and other guidelines on research using patient level data. The EGT advises the WPLs and the EPMT in the event a national or local medical ethical committee, animal review board or national authority (as the case may be) intends to terminate a clinical trial or animal trial in a specific country or at the facilities of a Participant; and with respect to the final standard operating procedures. It contributes to maintaining researchers’ awareness of ethical issues in conjunction with Project partners, and any relevant external agencies; and reports of any violation of the ethics standard operational procedures or any scientific (clinical or laboratory) misconduct to the Scientific Board.
Workpackage (WP) co-leaders handle all management activities at the Work Package level. They are responsible for:
- Execution of the WP Work Plan,
- Interaction between different WPs
- Reporting to EPMT and General Assembly on achievement and progress
- Organizing and managing the WP meetings