Description of the Metadata Schema

NFDI4Health developed a metadata schema (MDS) based on several international standards and studies' registries to collect metadata from clinical, epidemiological and Public Health studies, and associated resources.

The MDS is composed of a generic, Core MDS and further Modules to describe the design of certain NFDI4Health resources or for specific use cases.
The Core MDS contains elements:

  • that can be used for all kinds of NFDI4Health resources, such as studies, documents or questionnaires
  • that are specific to (sub-)studies and/or registries and/or secondary data sources only

This IG distinguishes between NFDI4Health resources registered in the NFDI4Health portal and HL7 FHIR Resources.

Sources of the Metadataschema

Beside elements and structures defined by NFDI4Health, the authors developed the MDS using following sources and standards:

Number of Source Sources or Standards URL
[1] DataCite https://doi.org/10.14454/3w3z-sa82
[2] ClinicalTrials.Gov https://prsinfo.clinicaltrials.gov/definitions.html
https://www.clinicaltrials.gov/ct2/about-studies/glossary
[3] DRKS https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields
[4]
[7]
[9]
[12]		 DDI https://ddialliance.org/Specification/DDI-CV/AnalysisUnit_1.0.html
https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html
https://ddialliance.org/Specification/DDI-CV/TypeOfInstrument_1.1.html
https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html|
[5] Taichman DB, et al. doi:10.1001/jama.2017.6514
[6] MIABIS https://github.com/BBMRI-ERIC/miabis
[8] Maelstroem doi: 10.1371/journal.pone.0200926
[10] Creative Commons https://creativecommons.org/about/cclicenses/
[11] WHO https://www.who.int/clinical-trials-registry-platform/unambiguous-trial-identification/the-universal-trial-number-(utn)
[13] NCI GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt
[14] EMA European Medicines Agency European Medicines Agency - ICH: E 6 (R2): Guideline for good clinical practice - Step 5 (europa.eu)
[15] ICD-10 https://icd.who.int/browse10/2019/en#
[16] ISRCTN https://www.isrctn.com/
[17] ENPADASI https://academic.oup.com/jn/article/148/2/285/4913031
[18] Zentrum für Krebsregisterdaten https://www.krebsdaten.de/
[19] Statistisches Bundesamt https://www.destatis.de/
[20] NIH Dietary Assessment Primer https://dietassessmentprimer.cancer.gov/profiles/
[21] DAPA-Toolkit https://dapa-toolkit.mrc.ac.uk/diet/subjective-methods/diet-history
[22] CDC.gov https://www.cdc.gov/csels/dsepd/ss1978/lesson3/section2.html
[23] NCI Dictionary of Cancer Terms https://www.cancer.gov/publications/dictionaries/cancer-terms|
[24] NIH https://www.nih.gov/

Authors

Subgroup "Metadata schema and standard mapping" of NFDI4Health and of the NFDI4Health Task Force COVID-19:

  • Haitham Abaza, Heidelberg Institute for Theoretical Studies (HITS)
  • Aliaksandra Shutsko, ZB MED – Information Centre for Life Sciences, Cologne
  • Martin Golebiewski, Heidelberg Institute for Theoretical Studies (HITS)
  • Sophie A. I. Klopfenstein, Berlin Institute of Health (BIH) at Charité, Universitätsmedizin Berlin
  • Carsten Oliver Schmidt, University Medicine Greifswald
  • Carina N. Vorisek, Berlin Institute of Health at Charité, Universitätsmedizin Berlin

With contributions from:

  • Claudia Brünings-Kuppe, Leibniz Institute for Prevention Research and Epidemiology (BIPS), Bremen
  • Vera Clemens, ZB MED – Information Centre for Life Sciences, Cologne
  • Johannes Darms, ZB MED – Information Centre for Life Sciences, Cologne
  • Sabine Hanß, University Medicine Göttingen
  • Timm Intemann, Leibniz Institute for Prevention Research and Epidemiology (BIPS), Bremen
  • Franziska Jannasch, German Institute of Human Nutrition (DIfE), Potsdam-Rehbrücke
  • Elisa Kasbohm, University Medicine Greifswald
  • Birte Lindstädt, ZB MED – Information Centre for Life Sciences, Cologne
  • Matthias Löbe, University Leipzig
  • Ester Orban, coverCHILD
  • Ines Perrar, University of Bonn
  • Manuela Peters, Leibniz Institute for Prevention Research and Epidemiology (BIPS), Bremen
  • Ulrich Sax, University Medicine Göttingen
  • Matthias Schulze, German Institute of Human Nutrition (DIfE), Potsdam-Rehbrücke
  • Claudia Schupp, coverCHILD
  • Florian Schwarz, German Institute of Human Nutrition (DIfE), Potsdam-Rehbrücke
  • Carolina Schwedhelm, MDC-Berlin
  • Stefan Strathmann, Georg-August-Universität Göttingen
  • Dagmar Waltemath, University Medicine Greifswald
  • Hannes Wünsche, Robert Koch Institute (RKI), Berlin
  • Atinkut A. Zeleke, University Medicine Greifswald