Launch of biorepository and database
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Launch of biorepository and database including five candidate bacterial reference strains, suitable for preclinical testing.
Implementation of quality standards, software and infrastructure to support data integration activities for Pillar A studies
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Implementation of quality standards, software and infrastructure to support data integration activities for Pillar A studies. Documentation describing the IT solution for Pillar A related data integration.
Establish data management plan
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A data management plan for COMBINE will be formulated and agreed with the partners and consortia management. The COMBINE plan will also form the basis for project data management plans within individual Pillar B and Pillar C projects and will cover GDPR, FAIR data, provenance (ALCOA) and data integration aspect.The following ethics issues to be addressed in the Data Management Plan (DMP): 1. The members of the consortium must confirm that they have appointed Data Protection Officers (DPOs) and the contact details of the DPO are made available to all data subjects involved in the research. For the members of the consortium not required to appoint a DPO under the General Data Protection Regulation a detailed data protection policy for the project must be elaborated and kept on file. It must be provided to IMI JU upon request2. A description of the technical and organisational measures that will be implemented to safeguard the rights and freedoms of the data subjects/research participants must be provided. A description of the security measures that will be implemented to prevent unauthorised access to personal data or the equipment used for processing must be provided.3. The applicants must clarify what the 'countries as yet unknown' are and what data will be imported from them to the EU. 4. For the personal data obtained from the non-EU countries the applicants must confirm that such transfers comply with the laws of the country in which the data was collected.5. Detailed information on the informed consent procedures in regard to data processing must be provided prior to the start of the relevant research activity.6. The applicants must confirm that the specific informed consent forms and information sheets for data processing (in language and terms intelligible to the participants) are kept on file. They must be provided to IMI JU upon request.7. In case of further processing of previously collected personal data, an explicit confirmation that the applicants have lawful basis for data processing and that the appropriate technical and organisational measures are in place to safeguard the rights of the data subjects must be provided. Relevant authorisations must be obtained and kept on file. The documents must be provided to IMI JU upon request.
Review of guidelines and literature around the development of monoclonal antibodies against AMR pathogens
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Review of guidelines and literature around the development of monoclonal antibodies against AMR pathogens.
Review of guidelines and literature
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Review of guidelines and literature on vaccines with input from expert workshop on integrated data analysis.
Implementation of quality standards, software and infrastructure to support data integration activities for data arriving from Pillar B and C projects
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Implementation of quality standards, software and infrastructure to support data integration activities for data arriving from Pillar B and C projects. Documentation describing the IT solution for Pillar B and C related data integration.
Updated data management plan
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Prepare an updated data management plan, taking into account the experience gained in the project implementation period.
Report on relationships between pre-clinical targets and clinical outcomes
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Report on relationships between pre-clinical targets and clinical outcomes.
Charter for the Data Management Group
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Document describing membership, roles, planned activities and responsibilities of the cross-accelerator DMG. All Data Management Champions will subscribe to the charter.
