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

e Clinical Forum / PhRMA EDC eSource Task Force 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 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: 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.

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

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. MestlerProcter & Gamble Pharmaceuticals, PhRMA EDC Taskforce, eClinical Forum Suzanne BishopSKB Consulting, eClinical Forum US Richard PerkinsConSept Consulting, eClinical Forum EU EHR/CR-FP Functional Profile Working Group (International Group) Mathias PoensgenAltana Pharma AG / Nycomed Gary DruckerBayer Healthcare, Pharmaceuticals Tricia GregoryBoehringer Ingelheim Pharmaceuticals Darlene KalinowskiBristol Myers Squib Jane Griffin, RPhCerner Corporation (EHR vendor) Marie MacDonaldClinPhone Inc (Clinical technology vendor) Linda KingEli Lilly & Company Vincente RodriguezEli Lilly & Company Jay Levine FDA Joe Salewski FDA Christian ReichGenstruct Frank JensenLundbeck Pharmaceuticals, EFPIA Catherine CélingantMillennium Pharmaceuticals, Inc. Harry GreenspunNorthrop Grumman Health Solutions Mitra RoccaNovartis Pharmaceuticals Mika MustonenOrion Pharmaceuticals TBDEuroRec Q-Rec Miguel ValenzuelaRoche Products Limited Daijin KimPfizer Suzanne Markel-FoxGSK

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: Identify critical capabilities (requirements) for clinical research utilizing EHR systems through: HL7 EHR-S FMHL7 EHR-S FM Q-Rec EHR FMQ-Rec EHR FM + Clinical Research-specific requirements+ Clinical Research-specific requirements Submit to HL7 for “standards” acceptanceSubmit to HL7 for “standards” acceptance Submit to CCHIT & Q-Rec for Certification ApprovalSubmit to CCHIT & Q-Rec for Certification ApprovalOutcomes: EHR Vendors: provided with encouragement & requirements for incorporating clinical research functions into their systems 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 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.) 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 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 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 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. Functions will be divided into levels along the evolution to this ultimate goal.

e Clinical Forum / PhRMA EDC eSource Task Force 10 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 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. Integrated Research System Core Interoperable Tier 1Tier 2 Tier 3 Site eSource Emerging and Future EHR-Research Connectivity and Complexity 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

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