MOSAIC – A Modular Approach to Data Management in Epidemiological Studies

Summary

Introduction: In the context of an increasing number of multi-centric studies providing data from different sites and sources the necessity for central data management (CDM) becomes undeniable. This is exacerbated by a multiplicity of featured data types, formats and interfaces. In relation to methodological medical research the definition of central data management needs to be broadened beyond the simple storage and archiving of research data.

Objectives: This paper highlights typical requirements of CDM for cohort studies and registries and illustrates how orientation for CDM can be provided by addressing selected data management challenges.

Methods: Therefore in the first part of this paper a short review summarises technical, organisational and legal challenges for CDM in cohort studies and registries. A deduced set of typical requirements of CDM in epidemiological research follows.

Results: In the second part the MOSAIC project is introduced (a modular systematic approach to implement CDM). The modular nature of MOSAIC contributes to manage both technical and organisational challenges efficiently by providing practical tools. A short presentation of a first set of tools, aiming for selected CDM requirements in cohort studies and registries, comprises a template for comprehensive documentation of data protection measures, an interactive reference portal for gaining insights and sharing experiences, supplemented by modular software tools for generation and management of generic pseudonyms, for participant management and for sophisticated consent management.

Conclusions: Altogether, work within MOSAIC addresses existing challenges in epidemiological research in the context of CDM and facilitates the standardized collection of data with pre-programmed modules and provided document templates. The necessary effort for in-house programming is reduced, which accelerates the start of data collection.

Keywords

Medical data management - data privacy protection - informed consent - pseudonyms - record linkage

• References

• 1 Higgins S. The DCC Curation Lifecycle Model. The International Journal of Digital Curation 2008; 3 (01) 134-140
• 2 Committee on Scientific Library Services:Subcommittee on Information Management. Recommendations for Secure Storage and Availability of Digital Primary Research Data (Empfehlungen zur gesicherten Aufbewahrung und Bereit-stellung digitaler Forschungsprimärdaten). [Online]. Bonn. 2009. [cited 2015 02 10]. Available from http://www.dfg.de/download/pdf/foerderung/programme/lis/ua_inf_empfehlungen_200901_en.pdf.
• 3 Jensen U. Guidelines for the management of research data (Leitlinien zum Management von Forschungsdaten). Technical Report. Köln: GESIS - Leibniz Institute for Social Sciences, Social Sciences. 2012
• 4 Winter A, Funkat G, Haeber A, Mauz-Koerholz C, Pommerening K, Smers S. , et al. Integrated Information Systems for Translational Medicine. Methods Inf Med 2007; 46 (05) 601-607 doi: 10.1160/ME9063
• 5 Sariyar M, Borg A, Pommerening K. Evaluation of Record Linkage Methods for Iterative Insertions. Methods Inf Med 2009; 48 (05) 429-437 doi: 10.3414/ME9238
• 6 Völzke V, Alte D, Schmidt CO, Radke D, Lorbeer R. Cohort Profile: The Study of Health in Pomerania. International Journal of Epidemiology 2011; 40 (02) 294-307 doi: 10.1093/ije/dyp394
• 7 Grabe H, Assel H, Bahls T, Dörr M, Endlich K, Endlich N. , et al. Cohort profile: Greifswald approach to individualized medicine (GANI_MED). Journal of Translational Medicine 2014; 12: 144 doi: 10.1186/1479-5876-12-144
• 8 The German National Cohort (Nationale Kohorte e.V.). The German National Cohort Website. [Online]. 2014. [cited 2015 02 10]. Available from http://www.nationale-kohorte.de/content/Datenschutzkonzept_130314.pdf.
• 9 German Centre for Cardiovascular Research (DZHK). dzhk.de. [Online]. 2015. [cited 2015 02 10]. Available from http://dzhk.de/.
• 10 Meyer J, Ostrzinski S, Fredrich D, Havemann C, Krafczyk J, Hoffmann W. Efficient data management in a large-scale epidemiology research project. Comput Methods Programs Biomed 2012; 107 (03) 425-435 doi: 10.1016/j.cmpb.2010.12.016
• 11 German Federal Office for Information Security (Bundesamt für Sicherheit in der Informationstechnik). BSI-Standard 100-2 IT-Grundschutz-Vorgehensweise. Bonn: German Federal Office for Information Security (Bundesamt für Sicherheit in der Informationstechnik); 2008.
• 12 Pommerening K, Drepper J, Helbing K, Ganslandt T. Guideline for Data Protection in Medical Research Projects: TMF's generic solutions 2.0. 1st ed. Berlin: 2014
• 13 MOSAIC. The Reference Portal plan.Tau. [Online]. 2014. [cited 2015 02 24]. Available from https://mosaic-greifswald.de/qa/info.
• 14 Greenspan G. Question2Answer. [Online]. [cited 2015 2 24]. Available from. http://www. question2answer.org/.
• 15 Fellegi I, Sunter A. A theory for record linkage. Journal of the American Statistical Association 1969; 64 (328) 1183-1210 doi: 10.1080/01621459.1969.10501049
• 16 PrimeTek. PrimeFaces. [Online]. 2014. [cited 2015 2 24]. Available from http://primefaces.org/.
• 17 Bahls T, Liedtke W, Geidel L, Langanke M. Ethics Meets IT: Aspects and elements of Computer-based informed consent processing. In Fischer T, Langanke M, Marschall P. , et al. editors Individualized medicine, ethical, economical and historical perspectives. Springer: 2015: 209-229
• 18 Geidel L, Bahls T, Hoffmann W. Ein generisches Pseudonymisierungswerkzeug als Modul des Zentralen Datenmanagements medizinischer Forschungsdaten. In Löffler M, Riedel-Heller S. editors Abstractband 8th Annual Conference of the German Society for Epidemiology (DGEpi) e.V. and 1st International LIFE Symposium (Abstractband 8. Jahrestagung der Deutschen Gesellschaft für Epidemiologie und 1. Internationales LIFE Symposium). Leipzig. 2013: 245-246
• 19 OpenClinica LLC. Open Clinica - Open Source for Clinical Research. [Online]. 2015. [cited 2015 2 24]. Available from https://community.openclinica.com/.
• 20 The R Foundation. The R Project for Statistical Computing. [Online]. 2015. [cited 2015 2 24]. Available from http://www.r-project.org/.
• 21 The MOSAIC Project. MOSAIC Subversion Repository. [Online]. 2015. [cited 2015 2 24]. Available from http://www.mosaic-greifswald.de/submin.
• 22 Creative Commons. Creative Commons Attribution 4.0 International License. [Online]. 2013. [cited 2015 02 10]. Available from http://creativecommons.org/licenses/by/4.0/.
• 23 Free Software Foundation. GNU Affero General Public License. [Online]. 2007. [cited 2015 02 10]. Available from http://www.gnu.org/licenses/agpl-3.0.html.
• 24 Fraser H, Thomas D, Tomaylla J, Garcia N, Lecca L, Murray M. , et al. Adaptation of a web-based, open source electronic medical record system platform to support a large study of tuberculosis epidemiology. BMC Medical Informatics and Decision Making 2012; 12: 125 doi: 10.1186/1472-6947-12-125
• 25 Sariyar M, Borg A, Heidinger O, Pommerening K. A practical framework for data management processes and their evaluation in population based medical registries. Informatics for Health and Social care 2013; 38 (02) 104-119 doi: 10.3109/17538157.2012.735731
• 26 Muscholl M, Lablans M, Wagner T, Ückert F. OSSE - open source registry software solution. Orphanet Journal of Rare Diseases 2014; 9 Suppl 1 doi: 10.1186/1750-1172-9-S1-O9
• 27 >TMF e.V. The TMF PID-Generator. [Online]. 2014 [cited 2015 02 10]. Available from. http://www.tmf-ev.de/Themen/Projekte/V015_01_PID_Generator.aspx.
• 28 Muscholl M, Lablans M, Borg A, Ückert F. Integration des Identitätsmanagements für Forschungsdatenbanken in ETL-Prozesse am Beispiel der Mainzer Patientenliste. In: GMDS 2013. 58. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS). 2013. Lübeck: doi: 10.3205/13gmds052
• 29 TMF e.V. The TMF pseudonymization service (PSD), a tool for the reversible pseudonymization of medical research data. [Online]. 2014. [cited 2015 02 16]. Available from http://www.tmf-ev.de/Projekte/TMFProjekte/V000_01_PSD.aspx.
• 30 TMF e.V. Informed Consent - Software wizard of the TMF provides practical support. [Online]. 2007. [cited 2015 01 29]. Available from http://www.tmf-ev.de/News/articleType/ArticleView/articleId/223.aspx.
• 31 Heinze O, Birkle M, Köster L, Bergh B. Architecture of a consent management suite and integration into IHE-based regional health information networks. BMC Medical Informatics and Decision Making 2011; 11: 58 doi: 10.1186/1472-6947-11-58
• 32 Harris P, Taylor R, Thielke R, Payne J, Gonzalez N, Conde J. Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support. Journal of Biomedical Informatics 2009; 42 (02) 377-381 doi: 10.1016/j.jbi.2008.08.010