Skip to main content
Top
Published in: European Journal of Epidemiology 3/2019

Open Access 01-03-2019 | GUIDELINES

Guidelines and recommendations for ensuring Good Epidemiological Practice (GEP): a guideline developed by the German Society for Epidemiology

Authors: Wolfgang Hoffmann, Ute Latza, Sebastian E. Baumeister, Martin Brünger, Nina Buttmann-Schweiger, Juliane Hardt, Verena Hoffmann, André Karch, Adrian Richter, Carsten Oliver Schmidt, Irene Schmidtmann, Enno Swart, Neeltje van den Berg

Published in: European Journal of Epidemiology | Issue 3/2019

Login to get access

Abstract

Objective

To revise the German guidelines and recommendations for ensuring Good Epidemiological Practice (GEP) that were developed in 1999 by the German Society for Epidemiology (DGEpi), evaluated and revised in 2004, supplemented in 2008, and updated in 2014.

Methods

The executive board of the DGEpi tasked the third revision of the GEP. The revision was arrived as a result of a consensus-building process by a working group of the DGEpi in collaboration with other working groups of the DGEpi and with the German Association for Medical Informatics, Biometry and Epidemiology, the German Society of Social Medicine and Prevention (DGSMP), the German Region of the International Biometric Society (IBS-DR), the German Technology, Methods and Infrastructure for Networked Medical Research (TMF), and the German Network for Health Services Research (DNVF). The GEP also refers to related German Good Practice documents (e.g. Health Reporting, Cartographical Practice in the Healthcare System, Secondary Data Analysis).

Results

The working group modified the 11 guidelines (after revision: 1 ethics, 2 research question, 3 study protocol and manual of operations, 4 data protection, 5 sample banks, 6 quality assurance, 7 data storage and documentation, 8 analysis of epidemiological data, 9 contractual framework, 10 interpretation and scientific publication, 11 communication and public health) and modified and supplemented the related recommendations. All participating scientific professional associations adopted the revised GEP.

Conclusions

The revised GEP are addressed to everyone involved in the planning, preparation, execution, analysis, and evaluation of epidemiological research, as well as research institutes and funding bodies.
Footnotes
1
This point was added as a consequence of the peer-reviewing process of the English version of the GEP.
 
Literature
3.
go back to reference Hoffmann W, Latza U. Terschüren C [Guidelines and recommendations for ensuring Good Epidemiological Practice (GEP)—revised version after evaluation]. Gesundheitswesen. 2005;67:217–25.CrossRefPubMed Hoffmann W, Latza U. Terschüren C [Guidelines and recommendations for ensuring Good Epidemiological Practice (GEP)—revised version after evaluation]. Gesundheitswesen. 2005;67:217–25.CrossRefPubMed
5.
go back to reference Guidelines for good epidemiology practices for occupational and environmental epidemiologic research. The Chemical Manufacturers Association’s Epidemiology Task Group. J Occup Med. 1991;33:1221–9. Guidelines for good epidemiology practices for occupational and environmental epidemiologic research. The Chemical Manufacturers Association’s Epidemiology Task Group. J Occup Med. 1991;33:1221–9.
6.
go back to reference Altpeter E, Burnand Bernard, Capkun G, Carrel R, Cerutti B, Mäusezahl-Feuz M, Gassner M, Junker C, Künzli N, Lengeler C, Minder C, Rickenbach M, Schorr D, Vader J-P, Zemp E. Essentials of Good Epidemiological Practice. Soz Präventivmed. 2005;50:12–5.CrossRefPubMed Altpeter E, Burnand Bernard, Capkun G, Carrel R, Cerutti B, Mäusezahl-Feuz M, Gassner M, Junker C, Künzli N, Lengeler C, Minder C, Rickenbach M, Schorr D, Vader J-P, Zemp E. Essentials of Good Epidemiological Practice. Soz Präventivmed. 2005;50:12–5.CrossRefPubMed
8.
go back to reference Swaen GMH, Langendam M, Weyler J, Burger H, Siesling S, Atsma WJ, Bouter L. Responsible epidemiologic research practice: a guideline developed by a working group of the Netherlands Epidemiological Society. J Clin Epidemiol. 2018;100:111–9.CrossRefPubMed Swaen GMH, Langendam M, Weyler J, Burger H, Siesling S, Atsma WJ, Bouter L. Responsible epidemiologic research practice: a guideline developed by a working group of the Netherlands Epidemiological Society. J Clin Epidemiol. 2018;100:111–9.CrossRefPubMed
12.
go back to reference Starke D, Tempel G, Butler J, Starker A, Zühlke C, Borrmann B. Gute Praxis Gesundheitsberichterstattung—Leitlinien und Empfehlungen. [Good practice in health reporting—guidelines and recommendations]. Robert Koch Institute. https://doi.org/10.17886/rki-gbe-2017-001 (2017). Accessed 23 Oct 2018. Starke D, Tempel G, Butler J, Starker A, Zühlke C, Borrmann B. Gute Praxis Gesundheitsberichterstattung—Leitlinien und Empfehlungen. [Good practice in health reporting—guidelines and recommendations]. Robert Koch Institute. https://​doi.​org/​10.​17886/​rki-gbe-2017-001 (2017). Accessed 23 Oct 2018.
22.
go back to reference Council of Europe. Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine (bioethics convention). ETS No.164. Oviedo. https://rm.coe.int/168007cf98 (1997). Accessed 18 Oct 2018. Council of Europe. Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: convention on human rights and biomedicine (bioethics convention). ETS No.164. Oviedo. https://​rm.​coe.​int/​168007cf98 (1997). Accessed 18 Oct 2018.
23.
go back to reference Harnischmacher U, Ihle P, Berger B, Goebel JW, Scheller J. Checkliste und Leitfaden zur Patienteneinwilligung—Grundlagen und Anleitung für die klinische Forschung [Patient consent checklist and guide—the basics and guidance for clinical research]. 1st ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2006. Harnischmacher U, Ihle P, Berger B, Goebel JW, Scheller J. Checkliste und Leitfaden zur Patienteneinwilligung—Grundlagen und Anleitung für die klinische Forschung [Patient consent checklist and guide—the basics and guidance for clinical research]. 1st ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2006.
24.
go back to reference Hansen MM, Miron-Shatz T, Lau AYS, Paton C. Big data in science and healthcare: a review of recent literature and perspectives: contribution of the IMIA Social Media Working Group. Yearb Med Inform. 2014;9(1):21–6.PubMedPubMedCentral Hansen MM, Miron-Shatz T, Lau AYS, Paton C. Big data in science and healthcare: a review of recent literature and perspectives: contribution of the IMIA Social Media Working Group. Yearb Med Inform. 2014;9(1):21–6.PubMedPubMedCentral
25.
go back to reference Binder H, Blettner M. Big data in medical science—a biostatistical view. Part 21 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2015;112:137–42.PubMedPubMedCentral Binder H, Blettner M. Big data in medical science—a biostatistical view. Part 21 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2015;112:137–42.PubMedPubMedCentral
26.
go back to reference Lipworth W, Mason PH, Kerridge I, Ioannidis JPA. Ethics and epistemology in big data research. J Bioeth Inquiry. 2017;14:489–500.CrossRef Lipworth W, Mason PH, Kerridge I, Ioannidis JPA. Ethics and epistemology in big data research. J Bioeth Inquiry. 2017;14:489–500.CrossRef
27.
30.
go back to reference Röhrig B, du Prel J-B, Wachtlin D, Blettner M. Studiendesign in der medizinischen Forschung. Teil 2 der Serie zur Bewertung wissenschaftlicher Publikationen [Study design in medical research. Part 2 of the series for the evaluation of scientific publications]. Dtsch Arztebl Int. 2009;106(11):184–9.PubMedPubMedCentral Röhrig B, du Prel J-B, Wachtlin D, Blettner M. Studiendesign in der medizinischen Forschung. Teil 2 der Serie zur Bewertung wissenschaftlicher Publikationen [Study design in medical research. Part 2 of the series for the evaluation of scientific publications]. Dtsch Arztebl Int. 2009;106(11):184–9.PubMedPubMedCentral
31.
go back to reference Röhrig B, du Prel J-B, Wachtlin D, Blettner M. Studiendesign in der medizinischen Forschung. Teil 3 der Serie zur Bewertung wissenschaftlicher Publikationen [Study design in medical research. Part 3 of the series for the evaluation of scientific publications]. Dtsch Arztebl Int. 2009;106(15):262–8.PubMedPubMedCentral Röhrig B, du Prel J-B, Wachtlin D, Blettner M. Studiendesign in der medizinischen Forschung. Teil 3 der Serie zur Bewertung wissenschaftlicher Publikationen [Study design in medical research. Part 3 of the series for the evaluation of scientific publications]. Dtsch Arztebl Int. 2009;106(15):262–8.PubMedPubMedCentral
33.
go back to reference Rienhoff O, Semler SC. Terminologien und Ordnungssysteme in der Medizin—Standortbestimmung und Handlungsbedarf in den deutschsprachigen Ländern. Standortbestimmung und Handlungsbedarf in den deutschsprachigen Ländern [Terminology and classification systems in medicine—determination of position and need for action in the German-speaking countries]. 1st ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2015. Rienhoff O, Semler SC. Terminologien und Ordnungssysteme in der Medizin—Standortbestimmung und Handlungsbedarf in den deutschsprachigen Ländern. Standortbestimmung und Handlungsbedarf in den deutschsprachigen Ländern [Terminology and classification systems in medicine—determination of position and need for action in the German-speaking countries]. 1st ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2015.
35.
go back to reference Michalik C, Ngounongo S, Stausberg J. Von der Evaluierung zur Konsolidierung: Anforderungen an Kohortenstudien & Register IT—KoRegIT [From evaluation to consolidation: requirements for cohort studies & register IT—KoRegIT]. Berlin; 2015. Michalik C, Ngounongo S, Stausberg J. Von der Evaluierung zur Konsolidierung: Anforderungen an Kohortenstudien & Register IT—KoRegIT [From evaluation to consolidation: requirements for cohort studies & register IT—KoRegIT]. Berlin; 2015.
37.
go back to reference Pommerening K, Drepper J, Helbing K, Ganslandt T. Leitfaden zum Datenschutz in medizinischen Forschungsprojekten—Generische Lösungen der TMF 2.0” [Guideline for data protection in medical research projects. TMF’s generic solutions 2.0.]. 1st ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2014. Pommerening K, Drepper J, Helbing K, Ganslandt T. Leitfaden zum Datenschutz in medizinischen Forschungsprojekten—Generische Lösungen der TMF 2.0” [Guideline for data protection in medical research projects. TMF’s generic solutions 2.0.]. 1st ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2014.
39.
go back to reference Kiehntopf M, Böer K. Biomaterialbanken—Checkliste zur Qualitätssicherung. [Biomaterial banks—checklists for quality assurance] under collaboration of J. Goebel. 1st ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2008. Kiehntopf M, Böer K. Biomaterialbanken—Checkliste zur Qualitätssicherung. [Biomaterial banks—checklists for quality assurance] under collaboration of J. Goebel. 1st ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2008.
41.
go back to reference Nonnemacher M, Nasseh D, Stausberg J. Datenqualität in der medizinischen Forschung—Leitlinie zum adaptiven Management von Datenqualität in Kohortenstudien und Registern [Data quality in medical research—Guideline for adaptive data quality management in cohort studies and registries]. 2nd updated and revised ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2014. Nonnemacher M, Nasseh D, Stausberg J. Datenqualität in der medizinischen Forschung—Leitlinie zum adaptiven Management von Datenqualität in Kohortenstudien und Registern [Data quality in medical research—Guideline for adaptive data quality management in cohort studies and registries]. 2nd updated and revised ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2014.
42.
go back to reference Schönbrodt FD, Gollwitzer M, Abele-Brehm AE. Der Umgang mit Forschungsdaten im Fach Psychologie: Konkretisierung der DFG-Leitlinien [The handling of research data in the field of psychology: concretization of the DFG guidelines]. Im Auftrag des DGPs Vorstands (17.09.2016). Psychol Rundsch. 2017;68(1):20–35. https://doi.org/10.1026/0033-3042/a000341.CrossRef Schönbrodt FD, Gollwitzer M, Abele-Brehm AE. Der Umgang mit Forschungsdaten im Fach Psychologie: Konkretisierung der DFG-Leitlinien [The handling of research data in the field of psychology: concretization of the DFG guidelines]. Im Auftrag des DGPs Vorstands (17.09.2016). Psychol Rundsch. 2017;68(1):20–35. https://​doi.​org/​10.​1026/​0033-3042/​a000341.CrossRef
44.
go back to reference Huebner M, Vach W, le Cessie S. A systematic approach to initial data analysis is good research practice. J Thorac Cardiovasc Surg. 2016;151:25–7.CrossRefPubMed Huebner M, Vach W, le Cessie S. A systematic approach to initial data analysis is good research practice. J Thorac Cardiovasc Surg. 2016;151:25–7.CrossRefPubMed
47.
go back to reference Schneider UK. Sekundärnutzung klinischer Daten—Rechtliche Rahmenbedingungen mit einem Beitrag von Alexander Roßnagel und Gerrit Hornung. 1st ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2015. Schneider UK. Sekundärnutzung klinischer Daten—Rechtliche Rahmenbedingungen mit einem Beitrag von Alexander Roßnagel und Gerrit Hornung. 1st ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2015.
48.
go back to reference Moher D, Altman D, Schulz K, Simera I, Wager E. Guidelines for reporting health research: a user’s manual. 1st ed. Hoboken, NJ: Blackwell; 2014. Moher D, Altman D, Schulz K, Simera I, Wager E. Guidelines for reporting health research: a user’s manual. 1st ed. Hoboken, NJ: Blackwell; 2014.
49.
go back to reference von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, STROBE Initiative. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med. 2007;4(10):e296.CrossRef von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, STROBE Initiative. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med. 2007;4(10):e296.CrossRef
50.
go back to reference Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, Sørensen HT, von Elm E, Langan SM, RECORD Working Committee. The reporting of studies conducted using observational routinely-collected health data (RECORD) statement. PLoS Med. 2015;12(10):e1001885.CrossRefPubMedPubMedCentral Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, Sørensen HT, von Elm E, Langan SM, RECORD Working Committee. The reporting of studies conducted using observational routinely-collected health data (RECORD) statement. PLoS Med. 2015;12(10):e1001885.CrossRefPubMedPubMedCentral
51.
go back to reference Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.CrossRefPubMedPubMedCentral Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.CrossRefPubMedPubMedCentral
53.
go back to reference Von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ. 2007;335(7624):806–8.CrossRef Von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ. 2007;335(7624):806–8.CrossRef
54.
go back to reference Gallo V, Egger M, McCormack V, Farmer PB, Ioannidis JP, Kirsch-Volders M, Matullo G, Phillips DH, Schoket B, Stromberg U, Vermeulen R, Wild C, Porta M, Vineis P. Strengthening the reporting of observational studies in epidemiology-molecular epidemiology (STROBE-ME): an extension of the STROBE statement. Eur J Epidemiol. 2011;26(10):797–810.CrossRefPubMed Gallo V, Egger M, McCormack V, Farmer PB, Ioannidis JP, Kirsch-Volders M, Matullo G, Phillips DH, Schoket B, Stromberg U, Vermeulen R, Wild C, Porta M, Vineis P. Strengthening the reporting of observational studies in epidemiology-molecular epidemiology (STROBE-ME): an extension of the STROBE statement. Eur J Epidemiol. 2011;26(10):797–810.CrossRefPubMed
55.
go back to reference Swart E, Bitzer EM, Gothe H, Harling M, Hoffmann F, Horenkamp-Sonntag D, Maier B, March S, Petzold T, Röhrig R, Rommel A, Schink T, Wagner C, Wobbe S, Schmitt J. A consensus german reporting standard for secondary data analyses, Version 2. (STROSA-standardisierte berichtsroutine für sekundärdatenanalysen). Gesundheitswesen. 2016;78(S01):e145–60.PubMed Swart E, Bitzer EM, Gothe H, Harling M, Hoffmann F, Horenkamp-Sonntag D, Maier B, March S, Petzold T, Röhrig R, Rommel A, Schink T, Wagner C, Wobbe S, Schmitt J. A consensus german reporting standard for secondary data analyses, Version 2. (STROSA-standardisierte berichtsroutine für sekundärdatenanalysen). Gesundheitswesen. 2016;78(S01):e145–60.PubMed
56.
57.
go back to reference Lesch W, Schütt A. Gesundheitsforschung kommunizieren, Stakeholder Engagement gestalten. Grundlagen, Praxistipps und Trends. 1st ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2016. Lesch W, Schütt A. Gesundheitsforschung kommunizieren, Stakeholder Engagement gestalten. Grundlagen, Praxistipps und Trends. 1st ed. Berlin: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft; 2016.
Metadata
Title
Guidelines and recommendations for ensuring Good Epidemiological Practice (GEP): a guideline developed by the German Society for Epidemiology
Authors
Wolfgang Hoffmann
Ute Latza
Sebastian E. Baumeister
Martin Brünger
Nina Buttmann-Schweiger
Juliane Hardt
Verena Hoffmann
André Karch
Adrian Richter
Carsten Oliver Schmidt
Irene Schmidtmann
Enno Swart
Neeltje van den Berg
Publication date
01-03-2019
Publisher
Springer Netherlands
Published in
European Journal of Epidemiology / Issue 3/2019
Print ISSN: 0393-2990
Electronic ISSN: 1573-7284
DOI
https://doi.org/10.1007/s10654-019-00500-x

Other articles of this Issue 3/2019

European Journal of Epidemiology 3/2019 Go to the issue