Management Structure of the CloSed Project:
The PMO assists the Coordinator in the day-by-day project management and supports the Steering Board. It includes a full-time Project Manager and permanent professional staff from UKER. The PMO ensures effective communication within CloSed and with external bodies, supports the organisation and preparation of meetings and workshops and keeps records of these events.
The Independent Scientific Advisory Board (ISAB) has consultative functions and includes independent, external experts with expertise in paediatric intensive care medicine, pharmacology and ethics in paediatric research. The Independent Scientific Advisory Board gives input for the final protocols, monitors project’s progress and ensures the scientific and ethical integrity of the project, particularly with regard to the clinical trial.
The Data Safety Monitoring Board (DSMB) is an integral part of the clinical trial and comprises a group of external experts who are responsible for reviewing accumulating safety data from the on-going clinical trial as required and set out in a DSMB charter.
A Patient Advisory Board (PAB) ensures the involvement of patients and its representatives and has the aim to advice on and represent patients’ perspective regarding ethical, practical and communication issues during the project.
The General Assembly is the decision-making body of the Consortium. It includes one representative from each partner and guarantees that all partners are informed about the progress of the project and that consensus is achieved on matters of fundamental importance for the entire Consortium.
The Steering Board is the internal supervisory body for the execution of the project. It reports and is accountable to the General Assembly. It supports decisions on all matters pertaining to the scientific and administrative coordination of the project and comprises all work package leaders. The Steering Board is in charge of monitoring that all activities are consistent with the objectives of the CloSed project in order to ensure that milestones are reached and deliverables fulfilled in a timely fashion and with high scientific value.