1. Project Sponsors & Participants
Bayer
Boehringer Ingelheim
Bristol Myers Squib
Cerner Corporation
ClinPhone Inc.
Eli Lilly and Company
FDA
Glaxo SmithKline
Hoffman La Roche
Lundbeck
Millennium
NIH: NCI
Northrop Grumman
Novartis
Nycomed
Orion
Pfizer
Procter & Gamble
Sponsors:
EDC/eSource Taskforce
Gold level partners:
Procter & Gamble Pharmaceuticals
Pfizer
Eli Lilly & Company
In Cooperation With:
HL7 Technical Committee EuroRec Q-Rec

2. EHR / CR Profile Initiative Commitment to Industry Standards
Presentation to RCRIM
Atlanta, GA
17 September 2007
Catherine Célingant
On Behalf of the EHR/CR FP Working Group
Copyright EHR/CR Project

3. EHR-CR Profile Initiative Project Overview
Objective & Strategy
Develop a Clinical Research profile to incorporate into the EHR certification programs (US-CCHIT & EU-QRec) to facilitate the inclusion of EHR data in regulatory submissions
FDA CDER Division of Scientific Investigations to PhRMA EDC/eSource Taskforce
Interest in eSource but no certification in place for EHR systems
Invitations by HL7 TC (Lenel James) and Q-Rec (Georges DeMoor) to participate in an EHR certification activity to address Clinical Research needs
11/30/2018
Copyright EHR/CR Project

4. EHR-CR Profile Initiative Project Overview (continued)
Scope
Identify critical capabilities (requirements and functions) to conduct clinical research utilizing EHR systems based on:
HL7 EHR-S FM
Q-Rec EHR FM
+ Clinical Research-specific requirements
Reference and endorse industry standards (e.g., HL7, CDISC, CDASH)
Submit to HL7 for formal ballot (~1Q08)
Submit to CCHIT & Q-Rec for Certification Approval
11/30/2018
Copyright EHR/CR Project

5. EHR-CR Profile Initiative Project Overview (continued)
Desired Outcomes
Healthcare providers
Facilitate their participation in clinical research by decreasing data collection burden
Regulators
Assurance that submission data are generated from reliable sources
Sponsors
Certification will provide the basis for evaluating EHR systems as source data systems
EHR Vendors
Provided with encouragement & requirements for incorporating clinical research functionalities into their systems
11/30/2018
Copyright EHR/CR Project

6. (Minimum Requirement)
Emerging and Future EHR-Research Connectivity and Complexity
Interoperable
Core
Connected
Integrated
Site eSource
Site eSource
Research
System
Core
Tier 3
Tier 1
Core
(Minimum Requirement)
EHR systems holding some source data used in Clinical Research meet essential regulatory requirements
Electronic data can be electronically extracted such that it can be transferred and loaded into a research system
Research systems must still collect trial-specific data
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 holds the complete patient medical record including all clinical trial / research data
Connected
(Emerging Future)
All patient trial data collected via EHR structured data elements and transferred from EHR via automatic/electronic industry standards
No further duplication of EHR data
Trial-specific data and queries handled via Research system
Integrated
(Future Vision)
Relevant data from EHR and Research System components are seamlessly transferred in both directions with no need for data transcription,
EHR System can capture healthcare and trial-specific data
Trial data not collected at site is transferred to EHR, Research holds virtually no ‘source’ data.

7. Clinical Research Needs and Standards
Evolution
From Paper Based Clinical Research to Electronic
From Non-Normalized to Normalized Data
From Formatted Data Files to XML
Progression to a Future Interoperable State
11/30/2018
Copyright EHR/CR Project

8. Clinical Research Needs and Standards
HL7 Functional Model – Consistency across EHR vendor applications
CDISC (CDASH) – Clinical Data Content Standards
CDISC (SDTM) – Clinical Data Submission Standards geared towards facilitating analysis
HL7 Clinical Statement (basis for HL7 EHR) - Encounter data
CDISC-HL7 exchange standard - Data exchange between EHR and sponsor systems
Exchange must be bi-directional
11/30/2018
Copyright EHR/CR Project

9. Copyright EHR/CR Project
Back-up Slides
11/30/2018
Copyright EHR/CR Project

10. Working Group Membership
EHR/CR-FP Functional Profile Working Group (International Group)
Formed in November 2006
Global representation (Bio-pharmaceutical, EHR Vendor, Clinical Research Vendor, FDA, NIH, EuroRec Q-Rec, CDISC, PhRMA, EFPIA)
EHR/CR-FP Co-chairs
John D. Mestler Procter & Gamble Pharmaceuticals,
PhRMA EDC/eSource Taskforce, eClinical Forum
Suzanne Bishop SKB Consulting, eClinical Forum US
Richard Perkins ConSept Consulting, eClinical Forum EU
Catherine Célingant Millennium Pharmaceuticals, Inc.,
PhRMA EDC/eSource Taskforce, eClinical Forum
11/30/2018
Copyright EHR/CR Project

11. Working Group Membership (continued)
Marie MacDonald Astellas US LLC
Gary Drucker Bayer Healthcare, Pharmaceuticals
Tricia Gregory Boehringer Ingelheim Pharmaceuticals
Darlene Kalinowski Bristol Myers Squibb
Jane Griffin Cerner Corporation (EHR vendor)
David Stein ClinPhone Inc (Clinical technology vendor)
Linda King Eli Lilly & Company
Ian Hamilton Eli Lilly & Company
Jay Levine FDA
Armando Oliva FDA
Joe Salewski FDA
Susan Howard Glaxo SmithKline Pharmaceuticals
Frank Jensen Lundbeck Pharmaceuticals, EFPIA
John Speakman NIH / Cancer Research Foundation
Harry Greenspun Northrop Grumman Health Solutions
Mitra Rocca Novartis Pharmaceuticals
Mathias Poensgen Nycomed GmbH
Tina Hartikainen Orion Pharmaceuticals
Daijin Kim Pfizer Pharmaceuticals
Miguel Valenzuela Roche Products Limited
11/30/2018
Copyright EHR/CR Project

12. Tier 2 – Integrated (Future Vision)
Automatic bi-directional electronic exchange of all clinical research data; single point of data entry at investigator site
Electronic Health Record (EHR) System
Sponsor Clinical Research System
Possibility of use for Virtual Phase IV trials
Data and Queries
RDM Toolkit
Other data
Coding
Coding
Labs
Entry of
Patient’s Clinical Data
EHR:
All CDASH data domains
Trial-specific data
Single point of data entry
Data held by Research Systems:
Labs
CDASH & efficacy populated from EHR system
Other
EHR system able to collect all patient data as requested by sponsor
Physician/Investigator
EHR is repository for all patient data, including clinical trial / research data
August 2007