Electronic Health Records for Clinical Research EHR/CR

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Electronic Health Records for Clinical Research
EHR/CR Functional Profile

• July 2007

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Problem

• National (EU and US) initiatives for
  Interoperable Electronic Health Records (eHealth)
  are causing more source data for clinical
  research to be redundantly collected, first in
  EHR then printed and entered into EDC Systems
• Potential Pharmaceutical Research benefits of the
  EHR were NOT initially considered
• Better Patient Safety Monitoring
• Elimination of Redundant Data Entry
• Streamlined Healthcare and Clinical Research
  Processes
• Enhanced Recruitment (Patients and Investigators)
• Outcome Research
• Protocol Feasibility
• etc.

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The Challenge
Approaches To Clinical Trial Data Capture At
Investigator Sites
Patient visit
Historical
Healthcare
Research
Paper CRF
Research Database
Paper Record
Paper or Electronic Health Record
Emerging but Duplicative
Research Database
eCRF, ePRO, Labs
Hosted Data
EDC
Future Integration
EHR-S
Trial Specific Data
Electronic Health Record
Research Database
Trial
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Opportunity to make a Difference

• Invites by HL7 TC (Lenel James) and Q-Rec
  (Georges DeMoor) to participate in an EHR
  certification activity to address Clinical
  Research needs
• Project initiated to develop a Clinical Research
  Functional Profile (EHR/CRFP) that can be
  included in the EHR certification programs in
  both the US and EU in order to facilitate the
  inclusion of EHR source data in regulatory
  submissions

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EHR/CR-FP Co-chairs John D. Mestler Procter
Gamble Pharmaceuticals,
PhRMA EDC Taskforce, eClinical
Forum Suzanne Bishop SKB Consulting, eClinical
Forum US Richard Perkins ConSept Consulting,
eClinical Forum EU EHR/CR-FP Functional Profile
Working Group (International Group) Mathias
Poensgen Altana Pharma AG / Nycomed Gary
Drucker Bayer Healthcare, Pharmaceuticals Tricia
Gregory Boehringer Ingelheim Pharmaceuticals Darl
ene Kalinowski Bristol Myers Squib Jane Griffin,
RPh Cerner Corporation (EHR vendor) Marie
MacDonald ClinPhone Inc (Clinical technology
vendor) Linda King Eli Lilly Company Vincente
Rodriguez Eli Lilly Company Jay Levine
FDA Joe Salewski FDA Christian
Reich Genstruct Frank Jensen Lundbeck
Pharmaceuticals, EFPIA Catherine
Célingant Millennium Pharmaceuticals, Inc. Harry
Greenspun Northrop Grumman Health
Solutions Mitra Rocca Novartis
Pharmaceuticals Mika Mustonen Orion
Pharmaceuticals TBD EuroRec Q-Rec Miguel
Valenzuela Roche Products Limited Daijin
Kim Pfizer Suzanne Markel-Fox GSK
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Project Objectives

• Develop a Global EHR/Clinical Research Functional
  Profile
• (EHR/CR-FP)
• Identify critical capabilities (requirements) for
  clinical research utilizing EHR systems through
• HL7 EHR-S FM
• Q-Rec EHR FM
• Clinical Research-specific requirements
• Submit to HL7 for standards acceptance
• Submit to CCHIT Q-Rec for Certification
  Approval
• Outcomes
• EHR Vendors provided with encouragement
  requirements for incorporating clinical research
  functions into their systems
• Sponsors certification will provide basis for
  evaluating EHR systems as source data systems

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HL7 EHR/CR FM
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Profile Essential Now (EN)

• Ensure that patient data from an EHR system will
  meet clinical research regulatory requirements
  for data collection, management, extraction,
  security, and can be interpreted in a consistent
  manner (21 CFR Part 11, CSUCT, etc.)
• Functions must be present to use EHR data for
  clinical research without redundant re-keying and
  verifying

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Profile Essential Future

• Functions needed to improve efficiency and
  performance
• Functions necessary to ultimately conduct all
  clinical research data capture and management
  through national health information networks and
  systems.
• Functions will be divided into levels along the
  evolution to this ultimate goal.

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Emerging and Future EHR-Research Connectivity and
Complexity
Interoperable
Integrated
Core
Connected
Site eSource
Site eSource
Research System
Core
Tier 3

• Core
• (Minimum Requirement)
• EHR systems holding some source data used in
  Clinical Research meet essential regulatory
  requirements
• Electronic data can be electronically extracted
  but manually transferred into research systems
• Research systems must still collect
  trial-specific data

Tier 1
Tier 2

• Interoperable
• (Future Ideal)
• EHR and Research systems work seamlessly together
  and sit on same international network.
• Data access mining capabilities across
  healthcare research.
• EHR System satisfies all needs for data capture
  for a clinical trial and hold the complete
  patient medical record including all clinical
  trial / research data

• Connected
• (Emerging Future)
• All non-efficacy trial data collected via EHR
  structured data elements
• Clinical trial data transferred from EHR via
  automatic/electronic industry standards
• No further duplication of data entry

• Integrated
• (Future Vision)
• Relevant data from EHR and Research System
  components are seamlessly transferred in both
  directions. No data transcription, the EHR system
  functions as the patient data repository, trial
  data not collected at site is transferred to EHR,
  Research holds virtually no source data.
  Queries are handled electronically.

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EHR-CR Data Collection