Transcript Project Charter - EuroRec: European Institute for Health

Project Charter
Clinical Research Filtered Query (CRFQ) - pilot
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.
Roles and Responsibilities
 Leader: I. de Zegher, C. Mead
 Team Members:
• See enclosed table
 Steering Committee: OC from the EHR stakeholder workshop
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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
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
EHR Integration – Project Charter
slide 1
Ilias Iakovidis
Isabelle de Zegher
Veli Stroetmann
Georges De Moor
Gudrun Zahlmann
Jean Samuel
Petra Wilson
Mats Sundgren
Time Frame (proposal)
Milestone
Date
Kick-off TC – agreement on scope by team
Dec07
Template for organizational and financial evaluation
Dec07
Comment to service specification – HL7 ballot
Jan 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 recommendations
Dec 08
Project Charter – cont.
Clinical Research Filtered Query - pilot
Approach:
Project Deliverables:
 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
Measurement
Metric
Pilot implementation of CRFQ in 2 sponsors, 2
hospital, with 2 vendors (2+2+2)
Description of the 3 processes in scope fully
documents – in terms of changes
Business case documented with 70% certainty
Legal requirements – related to business process
changes – can be implemented without major
changes in regulations
EHR Integration – Project Charter
Baseline
0
0
Goal
2+2+2
Blue Sky
Anything more
than 2+2+2
2 processes 3 processes
0%
70%
80%
?
80%
100%
 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
slide 2
Participants lists
Isabelle de Zegher
Charlie Mead
Georges De Moor
Eric Morincomme
Christel Daniel
Philippe Lambin
Gudrun Zahlmann
Ulrike Schwarz-Boeger
Piere-Yves Lastic
Suzanne Markel-Fox
Sarah Payne
Isabelle de Zegher
Johan van der Lei
Marc Peeters
Rob Thwaites
Michael Thick
EHR Integration – Project Charter
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slide 3
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