1. EHR Integration – Project Charter slide 1 Goals  Support specification of the already started service specification within HL7 RCRIM –going to ballot early 2008 (see document in annex)  Evaluate business process changes in the context of protocol feasibility, patient recruitment and safety monitoring  Evaluate business case – benefits and cost for full implementation across the Health Care chain  Understand legal implications  Define roadmap on how to implement in full production Business benefits  Understand complexity of implementation on EHR integration for specific purpose across the Health Care value chain – with a documented business case that allow the different decision makers to decide on the way forward  Support informed decision for go/no decision on EHR integration for the use cases in scope Time Frame (proposal) Roles and Responsibilities  Leader : I. de Zegher, C. Mead  Team Members : See enclosed table  Steering Committee : OC from the EHR stakeholder workshop Ilias Iakovidis Isabelle de Zegher Veli Stroetmann Georges De Moor Gudrun Zahlmann Jean Samuel Petra Wilson Mats Sundgren Problem Statement: Evaluation of protocol feasibility against patient population, patient recruitment and monitoring patient population with specific safety conditions are today very difficult to achieve for clinical research organizations. Access to patient information is very fragmented; there are some centralized databases like GPRD, which allows to check specific patient criteria but this is not sufficient to cover a wider population. EHR offers new possibilities that need to be clarified and piloted. Project Scope:  Pilot implementation of a standard service such as CRFQ. A request would be issued by a clinical research organization, be forwarded to Health Care providers (hospital, third parties like GPRD, other regional or national Databases) to evaluate patient population against specific criteria.  Evaluate needed changes (business processes and organizational aspects, additional services, legal implications) to implement the service in full production.  Evaluate how to work together as a Health Care “continuum” to further defined service in the clinical research area Clinical Research Filtered Query (CRFQ) - pilot Project Charter MilestoneDate Kick-off TC – agreement on scope by teamDec07 Template for organizational and financial evaluationDec07 Comment to service specification – HL7 ballotJan 08 ? Use case finalized for protocol feasibility, patient recruitment, safety monitoring May 08 Implementation of pilot within 3 to 5 partners & evaluation Sept 08 Final recommendationsDec 08

2. EHR Integration – Project Charter slide 2 Approach:  Dec07.  Kickoff of the project (agreement on this charter)  Introduction to the CRFQ project – ongoing currently (see enclosed document)  Identification of partners ready to implement the services (preferably different organization than the ones that will pilot core data sets)  Agreement on the template – with draft use case – for business process clarification; identification of participants for each of the use case  Agreement on monthly TC + possibility for 1 day F2F in February/March  Feb/March (F2F workshop ?)  Draft business process for 3 aspects – identification of missing components (i.e. additional services) for full implementation  Draft identification with quantification of benefit  Draft identification with quantification of related cost  Draft identification of legal requirements  June  First version of pilot – agreement on testing scenario across several institutions  Consolidation of business case (benefit and cost)  Consolidation of legal requirements  Sept/Oct (F2F workshop ?)  Execution of pilot and lessons learned  Finalization of use case description with business process changes  Draft recommendations – including roadmap for implementation  Questions: Where do we publish results – as part of Collaboration Forum/Governance body  Overall SC with core data sets and third party to understand dependencies (only at SC level – not at team level)  Routinely share ‘exchange point/ commentary resource’ with legal stream to ensure alignment Project Deliverables: Project Charter – cont.  Pilot implementation for testing at least in one sponsor and one hospital; pilot based on technical Specification of CRFQ (not part of this project but input from this project very important at balloting time)  Description of new business process (on the complete HC value chain)– including CRFQ – for  Evaluation of protocol feasibility  Patient recruitment  Safety monitoring condition  Specification of legal requirements/constraints (to be provided as input to team working on Governance model)  Estimate of feasibility and cost for implementation of the service in full production – including a roadmap MetricBaselineGoalBlue Sky Pilot implementation of CRFQ in 2 sponsors, 2 hospital, with 2 vendors (2+2+2) 02+2+2Anything more than 2+2+2 Description of the 3 processes in scope fully documents – in terms of changes 02 processes3 processes Business case documented with 70% certainty0%70%80% Legal requirements – related to business process changes – can be implemented without major changes in regulations ?80%100% Measurement Clinical Research Filtered Query - pilot

3. EHR Integration – Project Charter slide 3 Participants lists