Status: PlannedLast updated on: 25/06/2019
1. Study identification
EU PAS Register NumberEUPAS13031
Official titleAlert generation using the case-population approach in the French claims databases
Study title acronymALCAPONE
Study typeObservational study
Brief description of the studyALCAPONE aims to assess the suitability of the French nationwide healthcare insurance system database (SNIIRAM and EGB) for drug safety signal generation based on the OMOP reference set and methodologies, and the case-population approach. Once the initial calibration is completed, methods will be tested on incident alerts and suspected drugs.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name Moore
First name Nicholas
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed28/12/201428/12/2014
Start date of data collection02/10/2017
Start date of data analysis01/11/2017
Date of interim report, if expected18/08/2017
Date of final study report31/12/2019
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 bodyDirection Générale de l’Offre de Soins (DGOS)100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Thurin
First name Nicolas
Address line 1146 Rue Leo Saignat
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557579209 
Alternative phone number33557574675 
Fax number (incl. country code)33557574740 
Public Enquiries
Title Dr 
Last name Thurin 
First name Nicolas 
Address line 1146 Rue Leo Saignat 
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557579209 
Alternative phone number33557574675 
Fax number (incl. country code)33557574740 
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