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 Roles and Responsibilities
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
Leader: I. de Zegher, C. Mead
sufficient to cover a wider population. EHR offers new possibilities that need to be clarified and piloted. Team Members:
Project Scope:
Pilot implementation of a standard service such as CRFQ. A request would be issued by a clinical See enclosed table
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.
Steering Committee: OC from the EHR stakeholder
Evaluate needed changes (business processes and organizational aspects, additional services, legal workshop
implications) to implement the service in full production. Ilias Iakovidis
Evaluate how to work together as a Health Care continuum to further defined service in the clinical
research area Isabelle de Zegher
Veli Stroetmann
Georges De Moor
Gudrun Zahlmann
Jean Samuel
Petra Wilson
Mats Sundgren

Goals Time Frame (proposal)

Support specification of the already started service specification within HL7
RCRIM going to ballot early 2008 (see document in annex) Milestone Date
Evaluate business process changes in the context of protocol feasibility,
patient recruitment and safety monitoring Kick-off TC agreement on scope by team Dec07
Evaluate business case benefits and cost for full implementation across the
Health Care chain Template for organizational and financial Dec07
Understand legal implications evaluation
Define roadmap on how to implement in full production
Comment to service specification HL7 Jan 08 ?
Business benefits ballot
Understand complexity of implementation on EHR integration for specific
Use case finalized for protocol feasibility, May 08
purpose across the Health Care value chain with a documented business
patient recruitment, safety monitoring
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 Implementation of pilot within 3 to 5 Sept 08
cases in scope partners & evaluation

Final recommendations Dec 08

EHR Integration Project Charter slide 1
Project Charter cont.

Clinical Research Filtered Query - pilot

Approach:
Project Deliverables: Dec07.
Pilot implementation for testing at least in one sponsor and one Kickoff of the project (agreement on this charter) Micros oft Word
hospital; pilot based on technical Specification of CRFQ (not part of Introduction to the CRFQ project ongoing currently Document
this project but input from this project very important at balloting (see enclosed document)
time) Identification of partners ready to implement the services (preferably
different organization than the ones that will pilot core data sets)
Description of new business process (on the complete HC value Agreement on the template with draft use case for business
chain) including CRFQ for process clarification; identification of participants for each of the use
case
Evaluation of protocol feasibility
Agreement on monthly TC + possibility for 1 day F2F in
Patient recruitment February/March
Feb/March (F2F workshop ?)
Safety monitoring condition Draft business process for 3 aspects identification of missing
Specification of legal requirements/constraints (to be provided as components (i.e. additional services) for full implementation
input to team working on Governance model) Draft identification with quantification of benefit
Draft identification with quantification of related cost
Estimate of feasibility and cost for implementation of the service in Draft identification of legal requirements
full production including a roadmap June
First version of pilot agreement on testing scenario across several
institutions
Measurement Consolidation of business case (benefit and cost)
Consolidation of legal requirements
Metric Baselin Goal Blue Sky Sept/Oct (F2F workshop ?)
e Execution of pilot and lessons learned
Pilot implementation of CRFQ in 2 sponsors, 2 0 2+2+2 Anything more Finalization of use case description with business process changes
hospital, with 2 vendors (2+2+2) than 2+2+2 Draft recommendations including roadmap for implementation
Description of the 3 processes in scope fully 0 2 3 processes
documents in terms of changes processes
Questions: Where do we publish results as part of Collaboration
Business case documented with 70% 0% 70% 80%
Forum/Governance body
certainty
Legal requirements related to business ? 80% 100%
process changes can be implemented Overall SC with core data sets and third party to understand
without major changes in regulations dependencies (only at SC level not at team level)
Routinely share exchange point/ commentary resource with legal stream
to ensure alignment

EHR Integration Project Charter slide 2

Participants lists

EHR Integration Project Charter slide 3