SALUS

Scalable, Standard based Interoperability Framework for Sustainable Pro-active Post Market Safety Studies

Coordinatore	SRDC YAZILIM ARASTIRMA VE GELISTIRME VE DANISMANLIK TICARET LIMITED SIRKETI    more  Organization address address: Silikon Bina 1.Kat No:14 ODTU Teknokent, CANKAYA city: ANKARA postcode: 6531 contact info Titolo: Dr. Nome: Gokce Banu Cognome: Laleci Erturkmen Email: send email Telefono: 903122000000 Fax: 903122000000
Nazionalità Coordinatore	Turkey [TR]
Totale costo	5˙077˙781 €
EC contributo	3˙325˙966 €
Programma	FP7-ICT Specific Programme "Cooperation": Information and communication technologies
Code Call	FP7-ICT-2011-7
Funding Scheme	CP
Anno di inizio	2012
Periodo (anno-mese-giorno)	2012-02-01   -   2015-01-31

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	SRDC YAZILIM ARASTIRMA VE GELISTIRME VE DANISMANLIK TICARET LIMITED SIRKETI  Organization address address: Silikon Bina 1.Kat No:14 ODTU Teknokent, CANKAYA city: ANKARA postcode: 6531 contact info Titolo: Dr. Nome: Gokce Banu Cognome: Laleci Erturkmen Email: send email Telefono: 903122000000 Fax: 903122000000	TR (ANKARA)	coordinator	0.00
2	AGFA HEALTHCARE N.V.  Organization address address: SEPTESTRAAT 27 city: MORTSEL postcode: 2640 contact info Titolo: Mr. Nome: Hans Cognome: Vandewyngaerde Email: send email Telefono: +32 3450 9816 Fax: +32 3 450 9809	BE (MORTSEL)	participant	0.00
3	ELECTRONIC RECORD SERVICES BV  Organization address address: DITLAAR city: AMSTERDAM postcode: 1066 EE contact info Titolo: Mr. Nome: René Cognome: Schippers Email: send email Telefono: +31 6 23961239 Fax: +31 847371789	NL (AMSTERDAM)	participant	0.00
4	EUROPEAN INSTITUTE FOR HEALTH RECORDS  Organization address address: C/O IDISS CROIX ROUGE FRANCAISE city: SAINT CHAMOND postcode: 42400 contact info Titolo: Prof. Nome: Georges Cognome: De Moor Email: send email Telefono: 3292101161 Fax: 3293313350	FR (SAINT CHAMOND)	participant	0.00
5	F. HOFFMANN-LA ROCHE AG  Organization address address: GRENZACHERSTRASSE city: BASEL postcode: 4070 contact info Titolo: Dr. Nome: Jamie Cognome: Robinson Email: send email Telefono: +41 61 68 79433 Fax: +41 61 68 88412	CH (BASEL)	participant	0.00
6	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)  Organization address address: 101 Rue de Tolbiac city: PARIS postcode: 75654 contact info Titolo: Ms. Nome: MIHAJA Cognome: AUGUSTE Email: send email Telefono: +33 1 48073415 Fax: +33 1 48073426	FR (PARIS)	participant	0.00
7	Lombardia Informatica S.p.A.  Organization address address: Via Don Minzoni city: Milano postcode: 20158 contact info Titolo: Dr. Nome: Roberto Cognome: Gussago Email: send email Telefono: +39 02 39331246 Fax: +39 02 39331229	IT (Milano)	participant	0.00
8	OFFIS EV  Organization address address: Escherweg city: OLDENBURG postcode: 26121 contact info Titolo: Dr. Nome: Wilfried Cognome: Thoben Email: send email Telefono: +49 441 9722 131 Fax: +49 441 9722 111	DE (OLDENBURG)	participant	0.00
9	Stiftelsen WHO Collaborating Centre for International Drug Monitoring  Organization address address: Bredgrand city: UPPSALA postcode: S-75140 contact info Titolo: Ms. Nome: Birgitta Cognome: Toreheim Email: send email Telefono: 4618656060 Fax: +46 18 65 60 80	SE (UPPSALA)	participant	0.00
10	TECHNISCHE UNIVERSITAET DRESDEN  Organization address address: HELMHOLTZSTRASSE city: DRESDEN postcode: 1069 contact info Titolo: Mr. Nome: CARSTEN Cognome: GLUECK Email: send email Telefono: +49 351 46342186 Fax: +49 351 46339742	DE (DRESDEN)	participant	0.00

Mappa

 Word cloud

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 Obiettivo del progetto (Objective)

Pre-approval clinical trials cannot possibly ensure that a drug will not have disastrous side effects once it arrives on the market. Post-approval safety data gathering was put in place to address this problem, but as implemented, it has not proven to be as effective as hoped. This is due to the fact that, current post market safety studies largely depend on the submission of spontaneous case reports where underreporting is a major problem. The need for a proactive approach is apparent, where safety data from multiple sources are actively monitored, linked and analyzed. Effective integration and utilization of electronic health records (EHR) can help to improve post-market safety activities on a proactive basis. There are prototype studies to monitor EHRs for simplifying ADE reporting, and also for signal detection by screening multiple EHRs, however these tools are directly built on top of EHR/EMR systems through proprietary interfaces. It is apparent that the promise of proactive, continuous monitoring of multiple sources cannot be achieved through such proprietary integrations. To facilitate wide scale proactive post market safety studies, there is a need for a new capacity enabling accessing the data locked in multiple different heterogonous EHR systems. In SALUS project, we aim to provide a standard-based interoperability framework that will enable execution of safety studies for mining and analyzing real-time patient data in communication with disparate heterogeneous EHR systems. SALUS will provide:n•tFunctional interoperability profiles enabling exchange of EHRsn•tSemantic interoperability solutions enabling meaningful interpretation of the exchanged EHRsn•tSecurity and Privacy mechanisms ensuring EHRs are shared in an ethical and safe wayn•tA novel framework for open-ended temporal pattern discovery for safety studies on top of EHR Systemsn•tImplementation of high potential use cases enabling secondary use of EHRs for post market safety studies