progress core data set team pierre-yves lastic, gudrun zahlmann

Progress Core data set team

Pierre-Yves Lastic, Gudrun Zahlmann

EHR Integration – Project Charter slide 2

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)

Roles and Responsibilities Leader: Gudrun Zahlmann, Pierre-Yves Lastic Team Members:

• See enclosed table Steering Committee: as for overall project

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

Core data set - pilot

Project Charter

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 [email protected] +49 (228) 26681501 +49 (176) 2668 333

Ulrike Schwarz-Boeger TU München [email protected] +49 (89) 41402409 +49 (177) 7272993

Pierre-Yves Lastic Sanofi-Aventis [email protected] +33 (1) 45 362591

Jos Devlies Eurorec [email protected] +32 (9) 240 57 22 +32 (475) 266 148

Udo Siegmann Parexel [email protected] +49 (30) 30685 275 +49 (171) 55 35 921

Paul Burke Gripagain [email protected]

Gudrun Zahlmann Siemens Medical [email protected] +49 (9131) 84 7944 +49 (175) 2971 295

Dipak Kalra UCL [email protected] +44 (20) 7288 5966

Philippe Lambin MAASTRO [email protected]

Georges deMoor EuroRec georges.demoor@upent,be

Christian Lovis [email protected]

Eric Maurincomme Agfa [email protected] +32 3444 7512

Frank Jensen Lundbeck [email protected] +45 3083 2843

Hugh Donovan Accenture [email protected] +1 (215) 206 1094

Christel Daniel INSERM [email protected] +33 660 48 41 33

Christian Ohmann Uni Düsseldorf [email protected] +49 (211) 811 9701

progress core data set team pierre-yves lastic, gudrun zahlmann

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