1. 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 which should include text fields
Use available standards like HL7, CDISC, EN 13606, BRIDG model etc
Identify qualified European countries for pilot applications according to the threee use cases
Go into real life pilots in 5 countries using multiple languages
Publish results as public recommendations
Roles and Responsibilities
Leader: G. Zahlmann, ??
Team Members:
See enclosed table
Steering Committee:
Ilias Iakovidis
Georges De Moor
Mark Peeters
Jean Samuel
Mats Sundgren
Petra Wilson
Gudrun Zahlmann
Isabelle de Zegher
Veli Stroetmann
Goals
Identify common data set common between CR community and clinical care community
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
Evaluate use of existing standards:::::
Core set is doable and is incremental to drive standardization forward
Time Frame (proposal)
Milestone
Date
Kick-off TC – agreement on scope by team
End of Nov07
Basic project outline
Dec07
Final project outline
Funding : resourcing proposal
Feb 08
Start project
May 08

2. Project Charter – cont. Core data set - pilot Project Deliverables:
Approach:
(to be further described)
Project proposal
Definition of core data set as q proof of concept in cross national arena
Publication under the aegis of ,,,,
Certification ideas re data quality
Measurement
Metric
Baseline
Goal
Blue Sky

3. Participants 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
Geneva Univ. Hospitals
Eric
Maurincomme
Agfa
Frank
Jensen
Lundbeck
Hugh
Donovan
Accenture
+1 (215)
Christel
Daniel
INSERM
Ohmann
Uni Düsseldorf
+49 (211)

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