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

2. 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 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
Project proposal sent to IMI
Sep 08
Start project
2009

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

4. 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

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

6. 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

7. 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

8. 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

9. Safety monitoring
Team not established yet

10. 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

11. Participant lists Michael Dahlweid Agfa Healthcare
+49 (228)
+49 (176)
Ulrike
Schwarz-Boeger
TU München
+49 (89)
+49 (177)
Pierre-Yves
Lastic
Sanofi-Aventis
+33 (1)
Jos
Devlies
Eurorec
+32 (9)
+32 (475)
Udo
Siegmann
Parexel
+49 (30)
+49 (171)
Paul
Burke
Gripagain
Gudrun
Zahlmann
Siemens Medical
+49 (9131)
+49 (175)
Dipak
Kalra
UCL
+44 (20)
Philippe
Lambin
MAASTRO
Georges
deMoor
EuroRec
Christian
Lovis
Eric
Maurincomme
Agfa
Frank
Jensen
Lundbeck
Hugh
Donovan
Accenture
+1 (215)
Christel
Daniel
INSERM
Ohmann
Uni Düsseldorf
+49 (211)