SCIENTIFIC AND ETHICAL ADVISORY BOARD (SEAB)
The Scientific and Ethical advisory Board (SEAB) is a consultative body which is formed to ensure and improve the scientific performance and the quality of results of REPO-TRIAL. The SEAB advises the General Assembly and the Managing Board upon the request together with the Coordinator, and provides non-binding advice to the General Assembly and the Managing Board as decision making support.
The members of the SEAB are invited to the annual GA meetings in order to monitor the progress within the work packages, to assess the scientific quality, and to give feedback to the Consortium members, but do not have a right to vote. The SEAB will also consider and mention any ethical issues which might require stronger attention or feedback.
The following renowned experts from the relevant scientific fields of REPO-TRIAL have agreed to be part of the REPO-TRIAL Scientific and Ethical Advisory Board:
- Michael Marletta, former Director Scripps Research Institute, USA
- Michael Mendelsohn, former CEO Franchise Cardiovascular, Merck & Co, USA
- Chandan K. Sen, Editor-in-Chief, Antioxidants & Redox Signalling, USA
- Joe Loscalzo, Network Medicine, Harvard University, USA
- David Harrison, Director of Clinical Pharmacology, Vanderbilt, USA
BOARD FOR QUALITY AND DIVERSITY ISSUES (BQDI)
The Board for Quality and Diversity Issues (BQDI) consist of at least 2 external experts in this field, representing both sexes. Its role is to promote and safeguard the highest possible standard of research results, duties in respect of quality and diversity that may require consideration within the REPO-TRIAL consortium. Its duties are
- to compile a quality plan (see work package 5) within the first 6 months of the project to ensure first-rate project output
- to ensure compliance with gender equalities legislation in every aspect of the project
- to advance equality of opportunity between people who share protected characteristics
- to embed the principles of equality and fairness into the day to day running of REPO-TRIAL
The members of this board will be determined soon.
CLINICAL TRIAL MANAGEMENT COMMITTEE (CTMC)
The clinical centres (UKE, MHH, UMCU), the coordinator (UM) and HMPC compose the Clinical Trial Management Committee (CTMC). Its role is to review work package 1 to 2 and 2 to 3 proposals, and rank according to medical need, FtO, feasibility, relevance to commROCG, likelihood of completion with relevant endpoints during duration of REPO-TRIAL. Members will assist in drafting the study protocol and facilitate recruitment. They commit to making every effort to contribute to speedy patient recruitment and/or to suggest additional centres. The CTMC will meet during SC meetings and, if needed, via tele- or video-conferences.
DATA MANAGEMENT BOARD (DMB)
The Data Management Board (DMB) is chaired by Anil Wipat, who has a long-standing expertise in data warehousing and will set up and maintain the data management tool of REPO-TRIAL for the Open Data Research Pilot. All work package leaders, as well as the Coordinator are members of the DMB. Its role is to provide strategic direction and overview across open data, restricted data, data sharing and linage. The DMB will meet half-yearly in person or remote to monitor data warehousing within the REPO-TRIAL project. The board will compile a data management plan within the first 6 months of the project and carry out the maintenance to integrate evolutionary changes occurring during the lifespan of the REPO-TRIAL project.