nfdi4health - German National Research Data Infrastructure for Personal Health Data

nfdi4health aims to create the most comprehensive inventory of German epidemiological, public health and clinical trial data to date. It builds a centralised data catalogue with elaborate search functionalities, sophisticated data access management, and a data analysis toolbox, while respecting stringent requirements for privacy concerning personal health data. Standardisation services ensure a high degree of interoperability. Use cases covering prototypical study types and areas of research show ...

This project bundles information about COVID-19 related studies and tools in Germany. It intends to provide an information hub for the different initiatives, their aims, their processes, standards and study protocols, as well as their available data and metadata. It is initiated by the German National Research Data Infrastructure for Personal Health Data (nfdi4health), a consortium that plans to establish a concept for a federated research data infrastructure for personal health data in Germany. ...

TA3 focusses on the services, service enabling tools, and software that NFDI4Health will provide to the user community. Most services and tools will be based on open source software that has already been developed by the (co-)applicants or by the broader scientific developer community. In close cooperation with TA4 and TA5, use case requirements and community feedback will help to further develop these tools and to foster interoperability of currently fragmented IT solutions for storage of metadata, ...

nfdi4health Dokumente und (interne) Daten, SOPs, etc., die relevant für das gesamte Konsortium sind

Key activities of TA1 concern the establishment of functional bodies and of the project governance for NFDI4Health.

NFDI4Health task area 2 targets core deficits in medical sciences, i.e. the lack of harmonised standards for data and data quality management in clinical trials, public health surveys, and epidemiological cohorts, as well as the lack of information on and access to relevant standards. By making standards available, TA2 will improve the findability, accessibility and interoperability of existing and novel data bodies. For this purpose, guidelines, standards and policies on data management and ...

With its focus on interaction, networking and exchange, task area 4 addresses the overall NFDI4Health Key Objective to support cooperation between clinical research, epidemiological and public health communities. It also provides training and education for the health research community and beyond, focusing on FAIR data principles.

Shared Space on OneDrive: https://onedrive.live.com/?id=4E57D2DCFD31954C%213715&cid=4E57D2DCFD31954C

The main objective of task area 5 of NFDI4Health is to implement or to at least explore the possibilities to implement these infrastructure components in specific use cases which reflect core needs of the scientific community related to health data research. The use cases will address a range of areas which will lay the ground for future expansion for full coverage of the broad range of data collected in health research.

Data protection regulations have to be taken into account on many levels of the infrastructure developed by NFDI4Health. Moreover, the health data managed by NFDI4Health belong to the so-called special categories of personal data, the processing of which is subject to particularly strict data protection requirements. But nevertheless, data protection law contains a variety of regulatory approaches of data processing for scientific research purposes, which are all aimed at a privileged treatment ...

Consortium website: https://covidclinical.net/

Slack: https://c19i2b2.slack.com/ Owner: Nils Gehlenborg (nils@hms.harvard.edu)

i2b2 tranSMART Foundation Call to Action: https://transmartfoundation.org/covid-19-call-to-action/

https://leoss.net/

Die Charité – Universitätsmedizin Berlin betreibt gemeinsam mit dem Berlin Institute of Health Clinical Study Center (BIH-CSC) eine zentrale Registerstudie ("Pa-COVID-19") und Phänotypisierungs- plattform für alle an der Charité behandelten Patienten mit COVID-19. Pa-COVID-19 dient der harmonisierten und standardisierten klinischen und molekularen Phänotypisierung von COVID-19 Patienten. Übergeordnetes Ziel ist die schnelle und umfassende Charakterisierung von COVID-19 zur Identifikation von ...

https://www.rd-alliance.org/groups/rda-covid19

Collection of cross-links to other sites that gather COVID-19 information

To achieve data “FAIRification by standardisation” and enable the user community to integrate heterogeneous and complex data, recommendations and guidelines will be developed for the consistent use of domain-specific standards for data formats, as well as for consistent data descriptions based on established metadata standards and terminologies. This standardisation concept will be based on existing standards, such as ISO 20691 and will include the definition of a minimal metadata set for ...

This task T2.3 will target data quality as the “degree to which a set of inherent characteristics of data fulfils requirements” and provide consented standards and metrics to assess the data quality at different stages of the scientific data lifecycle. (1) It will first consider FAIR standards in collaboration with the FAIRMetrics group, FAIRsharing, and RDA FAIR Data Maturity Model group. (2) The second focus will be on adherence to defined data and metadata standards as recommended by nfdi4health ...

T2.4 will define standardisation requirements and develop guidelines, as well as standard-based solutions for data access and interoperability in the defined use cases. To ensure compatibility with existing efforts aiming to improve data interoperability in medicine and healthcare, T2.4 also will coordinate its work closely with the same standardisation initiatives and technical committees of standardisation organisations as T2.2. To enable a seamless access and exchange of health data within the ...

This task aims for policies for data management and publication in order to make data of public health studies findable and interoperable. To find information about studies and (meta-)data and to ensure their interoperability, it is necessary to document the descriptive core elements in a structured way already when planning projects. This applies both to data management and to the subsequent publication of research results and data and is particularly important for research projects handling ...

https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021145

Eine diagnostische Studie der Stufe 1 zur Entwicklung des SARS-CoV-2-ELISA. Ziel der Studie ist die Bestimmung von Sensitivität und Spezifität des Tests bei Probanden mit bekannter Erkrankung und bei Kontrollpersonen.

https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021166

The NFDI4Health Task Force COVID-19 Metadata Schema (MDS) Mapping to FHIR contains a list of properties describing a resource (study, questionnaire or document) being registered in the Central Search Hub of the NFDI4Health Task Force COVID-19 and their mapping to FHIR.

The NFDI4Health Task Force COVID-19 Metadata Schema Mapping (Metadata Schema Mapping) contains a list of properties describing a resource being registered in the Study Hub of the NFDI4Health Task Force COVID-19 (Study Hub) and how those properties align with other standards (FHIRE, CDISK, DRKS, ITRCP)

The NFDI4Health Task Force COVID-19 Metadata Schema (Metadata Schema) contains a list of properties describing a resource being registered in the Study Hub of the NFDI4Health Task Force COVID-19 (Study Hub).

First selection of LOINC Codes for data extraction

Instructions and database scripts for extracting COVID-19 related data from i2b2

Owner: Nils Gehlenborg (nils@hms.harvard.edu)

Crosslinl (URL) to Gitlab info site on COVID-19 (University Medical Center Göttingen, Department of Medical Informatics)

The Research Data Alliance (RDA) is a volunteer community of over 10,500 professionals from 145 countries across the globe. In less than two months, the community responded to an urgent call for action and defined much needed, comprehensive recommendations and guidelines for data sharing under the present COVID-19 circumstances.

This is the fifth and final draft of the Recommendations and Guidelines from the RDA COVID-19 working group, and is open for public comment until 8th of June 2020. Following the open period, feedback will be considered and then the WG will seek endorsement of the document from the RDA governance bodies prior to final publication.

Draft guidelines and recommendations; fourth release, 15 May 2020, version for public review