Scientific and Ethical Advisory Board (SEAB)
The Scientific and Ethical advisory Board (SEAB) is an external consultative body which is formed to ensure and improve the scientific performance and the quality of results of MICROB-PREDICT. The SEAB advises the General Assembly (GA) and the Project Management Office (PMO) upon request, and provides non-binding advice as decision making support. Members of the SEAB are cordially invited to attend the annual GA meetings in order to monitor the progress within each work packages, assess the scientific quality, and to provide critique and feedback, but do not have a right to vote. The SEAB will also consider and mention any ethical issues which may require stronger attention.
Impact Board (IB)
The Impact Board (IB) consists of junior and senior members of MICROB-PREDICT, from academia and industry, as well as patient representatives. The IB is responsible for designing a structured communication plan for dissemination and the exploitation of the project’s results, monitor the steps being taken, and oversee and evaluate the comprehensive internal and external dissemination of the project’s results and knowledge gain (together with the Project Management Office, WP9 and WP10). In addition, the IB has to assign the responsibility for filing and protecting intellectual property rights (IPR).
Data and Safety Monitoring Committee (DSMC)
All members of the Data and Safety Monitoring Committee (DSMC) are independent of the trial and of the sponsoring organization. The DSMC will review any issues concerning the safety of the trial participants (e.g. by reviewing serious adverse events), identify strengths and weaknesses of the data hub, and review the integrity of the data and potential statistical issues, such as selection-bias, cross-over, failure-to-diagnose, failure-to-treat or failure-to-follow-up. Following trial completion, the DSMC will assist in interpretation of the final results and approve the main trial publication. Members of the DSMC will be elected in the second year of the project.
Clinical Trial Management Committee (CTMC)
The Clinical Trial Management Committee (CTMC) consists of all MICROB-PREDICT scientists that coordinate and supervise clinical trials, and is responsible for setting up and implementing the logistics around all clinical trials. It also provides support to MICROB-PREDICT members concerning the clinical trials, and reviews the results to assess whether any changes to the study protocol are necessary.