Electronic Health Records for Clinical Research EHR/CR – Functional Profile

1. Electronic Health Records for Clinical Research EHR/CR – Functional Profile July 2007

2. 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 EHRwereNOT 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. e Clinical Forum / PhRMA EDC eSource Task Force

3. The Challenge … Approaches To Clinical Trial Data Capture At Investigator Sites Patient visit Historical Research Healthcare Research Database Paper CRF Paper Record Paper or Electronic Health Record Emerging but Duplicative Research Database Hosted Data eCRF, ePRO, Labs EDC Future Integration EHR-S Electronic Health Record Trial Specific Data Research Database Trial e Clinical Forum / PhRMA EDC eSource Task Force

4. 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/CR–FP) 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 e Clinical Forum / PhRMA EDC eSource Task Force

5. 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 Darlene 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 e Clinical Forum / PhRMA EDC eSource Task Force

6. 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 e Clinical Forum / PhRMA EDC eSource Task Force

7. HL7 EHR/CR FM e Clinical Forum / PhRMA EDC eSource Task Force

8. 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 e Clinical Forum / PhRMA EDC eSource Task Force

9. 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. e Clinical Forum / PhRMA EDC eSource Task Force

10. Emerging and Future EHR-Research Connectivity and Complexity Interoperable Core Connected Integrated 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 • 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 Tier 1 Tier 2 • 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. e Clinical Forum / PhRMA EDC eSource Task Force

11. EHR-CR Data Collection e Clinical Forum / PhRMA EDC eSource Task Force