Deliverables
A data management plan - describing the data management life cycle for the data to be collected, processed and/or generated by ReSToRe - will be drafted according to the Guidelines on FAIR Data Management in Horizon 2020. In brief, the data management plan will contain details on the incidental findings policy as well as detailed information on the procedures that will be implemented for data collection, storage, protection, retention, sharing, merging, reuse and/or destruction). The plan will also include a privacy impact assessment. In other words, items that will be addressed in the data management plan include: What data will be collected / generated? What standards will be used be generated? What data will be exploited? What data will be shared/made open? How will data be curated and preserved?
We aim at implementing standardized clinical monitoring procedures for peptide-loaded tolDC and training study staff on clinical monitoring to affirm harmonization and standardization will be started prior beginning the clinical trial. Prior to commencement of the clinical trial, P1 (UA), P2 (UZA) and P4 (ICS) will organize seminars for all personnel involved in the clinical trial, a specialized training program for neurologists on diagnosis, patient enrolment, correct documentation and data collection, samples collection and follow up.
The applicants strongly believe in collaboration and dissemination of knowledge keeping in mind the patient’s best interests. Dissemination will be carried out as soon as possible with due regard to the interests of all partners. Dissemination and exploitation plans will be drafted following the requirements of the EC.
Prior to commencement of the clinical trial, P1 (UA), P2 (UZA) and P4 (ICS) will organize seminars for all personnel involved in the clinical trial, a specialized training program for neurologists on diagnosis, patient enrolment, correct documentation and data collection, samples collection and follow up. Regarding set-up and support for standardized and centralized use of MRI (WP6), IcoMetrix (P7) will provide the MRI protocol, operation manuals for acquisition and upload and training of the centers for acquisition and data transfer.
As part of ReSToRe's dissimination strategy, a website will be set up to promote public dissimination of project activities and research results. A private section for partners will also be included.
Publications
Author(s): Anja ten Brinke, Marc Martinez-Llordella, Nathalie Cools, Catharien M. U. Hilkens, S. Marieke van Ham, Birgit Sawitzki, Edward K. Geissler, Giovanna Lombardi, Piotr Trzonkowski, Eva Martinez-Caceres
Published in: Frontiers in Immunology, Issue 10, 2019, ISSN 1664-3224
DOI: 10.3389/FIMMU.2019.00181
Author(s): Barbara Willekens, Nathalie Cools
Published in: CNS Drugs, Issue 32/5, 2018, Page(s) 401-410, ISSN 1172-7047
DOI: 10.1007/s40263-018-0518-4
Author(s): Willekens B, Presas-Rodríguez, Mansilla M, Derdelinckx J, Lee W-P, Nijs G, De Laere M, Wens I, Cras P, Parizel PM, Van Hecke W, Ribbens A, Billiet T, Adams G, Couttenye M, Navarro-Barriuso J, Teniente-Serra A, Quirant-Sánchez B, López-Díaz de Cerio A, Inogés S, Prósper F, Kip A, Verheij H, Gross CC, Wiendl H, van Ham SM, ten Brinke A, Barriocanal AM, Massuet-Vilamajó A, Hens N, Berneman Z,
Published in: BMJ Open, Issue accepted for publication 23/7/2019, 2019, ISSN 2044-6055
