Status: Finalised First registered on: 01/10/2015
Last updated on: 11/12/2017
1. Study identification
EU PAS Register NumberEUPAS11157
Official titleIdentification of type 2 diabetes cases in a set of databases participating to the EMIF project
Study title acronym
Study typeObservational study
Brief description of the studyThe European Medical Information Framework (EMIF) project has the main objective of building an infrastructure for the efficient re-use of existing health care data for epidemiological research. Within the project, the EMIF-Platform represents a federation of heterogeneous sources of health data (e.g. administrative, hospital or primary care databases, disease registries, biobanks). One of the major challenges for the EMIF project is to deal with the different characteristics of the participating data sources in order to facilitate the execution of large multi-data base observational studies and generate high quality. For this purpose, a template data derivation process was specifically developed and the identification of Type 2 diabetes mellitus (T2DM) was used as a test case. The objectives of this study are: a) to establish a set of standard algorithms, each based on a single data domain, that will be used for the identification of patients with type 2 diabetes (T2DM) across heterogeneous sources of health data, b) to describe the data source-tailored combinations of standard algorithms recommended by the relevant local data base experts, c) to assess the impact of individual standard algorithms on the population of cases identified across different data sources.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsARS
Department/Research groupOsservatorio di Epidemiologia
Organisation/affiliationAgenzia regionale di sanità della Toscana (ARS)
Website/Homepagehttp://www.ars.toscana.it/it/
Details of (Primary) lead investigator
Title Dr
Last name Giuseppe
First name Roberto
Is this study being carried out with the collaboration of a research network?
Yes
European Medical Information Framework (EMIF)
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?9

PHARMO Institute
Erasmus MC Pharmacoepi
IMIM-Hospital del Mar Medical Research Institute and Universitat Pompeu Fabra, Barcelona, Spain
The Health Improvement Network, Cegedim Strategic Data Medical Research Ltd, London, United Kingdom
Arsenàl.IT Consortium, Veneto's Research Centre for eHealth Innovation, Treviso, Italy
Health Search, Italian College of General Practitioners and Primary Care, Florence, Italy
Department of Clinical Epidemiology, Aarhus University Hosptial, Aarhus, Denmark
Quretec, Software Technology and Applications Competence Center, University of Tartu, Tartu, Estonia
Countries in which this study is being conducted
International study

Denmark
Estonia
Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/2013
Start date of data collection30/04/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report31/01/201601/02/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherEU/EFPIA100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Giuseppe
First name Roberto
Address line 1Via Pietro Dazzi 1
Address line 250141 
Address line 3 
CityFlorence 
Postcode50141 
CountryItaly
Phone number (incl. country code)39-0554624341 
Alternative phone number 
Fax number (incl. country code) 
Email address giuseppe.roberto@ars.toscana.it
Public Enquiries
Title Dr 
Last name Giuseppe 
First name Roberto 
Address line 1Via Pietro Dazzi 1 
Address line 250141 
Address line 3 
CityFlorence 
Postcode50141 
CountryItaly 
Phone number (incl. country code)39-0554624341 
Alternative phone number 
Fax number (incl. country code) 
Email address giuseppe.roberto@ars.toscana.it 
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