Progress Core data set team Pierre-Yves Lastic, Gudrun Zahlmann

Project Charter Core data set - pilot Problem Statement: EHR data have the potential to be re-used for patient recruitment, EHR – EDC integration as well as for patient safety monitoring. In order to validate this potential it is needed to define a core data set that can be utilized for the majority of clinical studies and test it in a realistic European scenario whether those data are really searchable in real life EHR systems. This will be based on existing experiences of Pharma and Health IT companies as well as of existing European EHR activities. Project Scope: Define a core data set (data sets) that are useful for use cases recruitment, EHR – EDC integration and patient safety monitoring Use available standards like HL7, CDISC, EN 13606 under consideration of the BRIDG model Identify qualified European countries for pilot applications according to the threee use cases Go into real life pilots in 5 countries Publish results as industry recommendations Roles and Responsibilities Leader: Gudrun Zahlmann, Pierre-Yves Lastic Team Members: See enclosed table Steering Committee: as for overall project Goals Identify common data set Identify 5 European countries for piloting Validate the use cases in this scenario Certify data quality and trustworthiness of the used EHR systems Define business rules for use cases Business benefits Evaluate data quality and business cases of the 3 use cases on a European scale Time Frame (proposal) Milestone Date Kick-off TC – agreement on scope by team End of Nov07 Basic project outline Dec07 Final project outline 31.3.2008 Project proposal sent to IMI Sep 08 Start project 2009

Description of data set pilot for use case 1, 2 and 3

Core data sets Premise: there is a core data set that can become a starting point for the agreed upon use cases Several initiatives ongoing internationally (data model, terminologies, ontologies,standards) Not re-invent the wheel Team Pierre-Yves, Udo, Christel still the team sticks to the idea of a core data set – get hands dirty HL7, CEN <> CDISC CDASH data set in review (Clin Data Acquisition Standards Harmonization) + BRIDG Data model Messaging check based on real life trials terminologies: ICD 9/10, SNOMED ??, LOINC ??, MedDRA ?? – standardization per country at its best

Use cases Patient recruitment – Christian Ohmann EHR – EDC integration for trials – Duane Lawrence Safety monitoring – Pierre - Yves Lastic

Patient recruitment – existing initiatives EHR screening mass laboratory data (10) EHR solution to trial recruitment in physician groups (11) EHR-based Clinical Trial Alert System (12,13) Siemens acitvities regarding patient identification out of HER data (Remind application) Kaiser EMR system: KP HealthConnect in California Mayo Clinic, Rochester, Minnesota

Patient recruitment – new project build on top of core data set European scale recruitment service Feasibility studies Patient identification ECRIN activities Start with advanced European countries (Denmark, Finland, Sweden, Norway, UK, Netherlands) Next outline step today

EHR – EDC integration Single source initiative and discussions with FDA Starbrite project Munich pilot RFD – IHE profile (HIMSS 2007) RFD like fully integrated two way communication pilot on a larger scale, Stakeholders, based on core data set Proof of concept, what is the core data set coverage, what is existing in addition, what needs to be entered Proof of concept : processes , process integration

Safety monitoring Team not established yet

Link to third party and processes Out of such use case projects we will learn lessons: Concept of core data set working? Clinical relevance validated EHR system capability validation – completeness, serviceability Data quality validation Terminology in reality Semantic interoperability at a basic/pragmatic level (basis for service description) Link to process activities – per site, per region/country, per trial Technical basis for third party concept: what, how, when, how often

Participant lists Michael Dahlweid Agfa Healthcare michael.dahlweid@agfa.com +49 (228) 26681501 +49 (176) 2668 333 Ulrike Schwarz-Boeger TU München schwarz-boeger@lrz.tu-muenchen.de +49 (89) 41402409 +49 (177) 7272993 Pierre-Yves Lastic Sanofi-Aventis pierre-yves.lastic@sanofi-aventis.com +33 (1) 45 362591 Jos Devlies Eurorec jos.devlies@eurorec.org +32 (9) 240 57 22 +32 (475) 266 148 Udo Siegmann Parexel udo.siegmann@parexel.com +49 (30) 30685 275 +49 (171) 55 35 921 Paul Burke Gripagain paul.burke@chancelconsulting.com Gudrun Zahlmann Siemens Medical gudrun.zahlmann@siemens.com +49 (9131) 84 7944 +49 (175) 2971 295 Dipak Kalra UCL d.kalra@chime.ucl.ac.uk +44 (20) 7288 5966 Philippe Lambin MAASTRO philippe.lambin@maastro.nl Georges deMoor EuroRec georges.demoor@upent,be Christian Lovis chl@hcvge.ch Eric Maurincomme Agfa eric.maurincomme@gmail.com +32 3444 7512 Frank Jensen Lundbeck fj@lundbck.com +45 3083 2843 Hugh Donovan Accenture hugh.c.donovan@accenture.com +1 (215) 206 1094 Christel Daniel INSERM christel.daniel@spim.jussieu.fr +33 660 48 41 33 Ohmann Uni Düsseldorf Christian.Ohmann@uni-duesseldorf.de +49 (211) 811 9701