About the project
The QA-MB will provide all researchers and infrastructures in the NUM with comprehensive, easily accessible and needs-based support on methodology, biospecimens and specific aspects of regulation throughout the entire course of the study. Starting with (I) study planning, the QS-MB offers methodological advice on data and biosamples, including their preparation and utilisation. We also advise on the presentation of data protection and infrastructural aspects as well as NUM governance in patient records in the respective regulatory context. As part of (II) study implementation , the QS-MB ensures rapid support from a central helpdesk. In addition, training and counselling is offered, e.g. on amendments and training on SOPs. The BCU managers also carry out quality assurance audits at the NUM sites that collect biosamples. As a member of the (III) (dynamic) Use and Access Committee (UAC), QS-MB supports the release process, e.g. of biosamples, and advises applicants on the UAC.
The QA-MB will provide all researchers and infrastructures in the NUM with comprehensive, easily accessible and needs-based methodological support along the entire study process, tailored to their individual, current and future requirements. The QA-MB supports the harmonisation processes in the NUM and cooperates closely with all existing and newly established Reseach Infrastructures of the NUM.
The Network University Medicine stands above all for innovative clinical and clinical-epidemiological research in Germany, which takes place in a partnership-based, interdisciplinary and non-competitive framework. The current university medicine research landscape is characterised in particular by its high level of complexity, great dynamism, demand for rapid communication and a multitude of information flows. New concepts in clinical research, such as adaptive study designs, expand existing knowledge and create new approaches and experiences. Newly acquired knowledge and expanded competences will broaden our expertise in the consulting areas of study planning and implementation as well as associated topics in QS-MB in order to incorporate them into our future consulting on methods, biosamples and ethical-regulatory requirements in the NUM. The project coordination team consists of experienced scientists whose working methods are characterised by a combined classical and, where necessary, agile management style. Establishing and implementing this approach and other collaborative working tools together will be one of the future key tasks of the project coordination team, in addition to ensuring prompt and competent consultations.
The QS-MB implements comprehensive, easily accessible and broad methodological support along the entire course of the study in order to fulfil the individual needs of researchers in the NUM, taking into account current and future requirements. To achieve this, three important areas in the NUM have been bundled into the cross-sectional Methods and Biosample Hub (QS-MB) - the Methods Hub (Epidemiology Core Unit, ECU), the Biosample Hub (Biosample Core Unit, BCU) and the Ethics Coordination (EC).
The Methods Hub/ECU advisory unit aims to ensure a high methodological quality of clinical and clinical-epidemiological projects with regard to the planning, implementation, analysis and after-use of NUM projects. In this area, the clinical and genetic-epidemiological expertise is bundled with the knowledge and many years of experience in dealing with external care-related data (eVeDa), patient reported outcomes (PROs) and paediatric cohorts.
The Biospecimen Hub/BCU advisory unit will ensure the standardisation and harmonisation of biospecimens and associated data across NUM sites and studies and coordinate the outsourcing of locally stored biospecimens and the transfer to the relevant analytical laboratories for the research projects approved by the Use and Access Committee. The high and uniform quality of biosamples for studies and the NUM is ensured by regular audits at the NUM sites that collect biosamples. The BCU is responsible for ensuring that biosamples and the data generated from them are utilised efficiently and transparently.
The Ethics Coordination/EC advisory unit focuses on the harmonisation and standardisation of patient records at NUM. Ethical, data protection and regulatory requirements are taken into account, which are (further) developed across infrastructures and in cooperation with other relevant stakeholders and players where necessary. The EC advises researchers within the NUM on various infrastructures and on the further use of medical data and biosamples already collected for new research questions that go beyond the original purpose of the data collection (secondary use). The advisory unit is responsible for the further development of automated systems for informed patient consent. It focuses on interoperability, scalability and user-friendliness as well as modular and automatically retrievable consent content.
There is currently particularly close cooperation with two infrastructures within the NUM: the NUM Clinical Epidemiology and Study Platform (NUKLEUS) and the NUM Study Network (NUM SN). This is due to the organisational origin of QS-MB from NUKLEUS and the intensive involvement of QS-MB stakeholders in various studies within the NUM SN. Cooperation is supported by active communication, both within NUM and in exchange with the project management organisation.