EHR CR Project Sponsors Participants Bayer Sponsors Boehringer

EHR CR Project Sponsors & Participants: • Bayer Sponsors: • Boehringer Ingelheim • Bristol Myers Squib • Cerner Corporation • Clin. Phone Inc. EDC/e. Source Taskforce • Eli Lilly and Company • FDA Gold level partners: Procter & Gamble Pharmaceuticals Pfizer Eli Lilly & Company In Cooperation With: HL 7 Technical Committee Euro. Rec Q-Rec • Glaxo Smith. Kline • Hoffman La Roche • Lundbeck • Millennium • NIH: NCI • Northrop Grumman • Novartis • Nycomed • Orion • Pfizer • Procter & Gamble

EHR CR 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 2

EHR CR 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 Ph. RMA EDC/e. Source Taskforce Ø Interest in e. Source but no certification in place for EHR systems – Invitations by HL 7 TC (Lenel James) and Q-Rec (Georges De. Moor) to participate in an EHR certification activity to address Clinical Research needs 10/7/2020 Copyright EHR/CR Project 3

EHR CR EHR-CR Profile Initiative Project Overview (continued) Scope – Identify critical capabilities (requirements and functions) to conduct clinical research utilizing EHR systems based on: Ø Ø HL 7 EHR-S FM Q-Rec EHR FM + Clinical Research-specific requirements Reference and endorse industry standards (e. g. , HL 7, CDISC, CDASH) – Submit to HL 7 formal ballot (~1 Q 08) – Submit to CCHIT & Q-Rec for Certification Approval 10/7/2020 Copyright EHR/CR Project 4

EHR CR 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 10/7/2020 Copyright EHR/CR Project 5

Emerging and Future EHR-Research Connectivity and Complexity EHR CR Core Connected Integrated Interoperable Site e. Source Research System 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 1 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 Tier 3 Tier 2 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. 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 6

EHR CR 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 10/7/2020 Copyright EHR/CR Project 7

EHR CR Clinical Research Needs and Standards • HL 7 Functional Model – Consistency across EHR vendor applications • CDISC (CDASH) – Clinical Data Content Standards • CDISC (SDTM) – Clinical Data Submission Standards geared towards facilitating analysis • HL 7 Clinical Statement (basis for HL 7 EHR) Encounter data • CDISC-HL 7 exchange standard - Data exchange between EHR and sponsor systems – Exchange must be bi-directional 10/7/2020 Copyright EHR/CR Project 8

EHR CR Back-up Slides 10/7/2020 Copyright EHR/CR Project 9

EHR CR Working Group Membership EHR/CR-FP Functional Profile Working Group (International Group) Ø Formed in November 2006 Ø Global representation (Bio-pharmaceutical, EHR Vendor, Clinical Research Vendor, FDA, NIH, Euro. Rec Q-Rec, CDISC, Ph. RMA, EFPIA) EHR/CR-FP Co-chairs John D. Mestler Procter & Gamble Pharmaceuticals, Ph. RMA EDC/e. Source Taskforce, e. Clinical Forum Suzanne Bishop SKB Consulting, e. Clinical Forum US Richard Perkins Con. Sept Consulting, e. Clinical Forum EU Catherine Célingant Millennium Pharmaceuticals, Inc. , Ph. RMA EDC/e. Source Taskforce, e. Clinical Forum 10/7/2020 Copyright EHR/CR Project 10

EHR CR Working Group Membership (continued) Members • • • • • Marie Mac. Donald Gary Drucker Tricia Gregory Darlene Kalinowski Jane Griffin David Stein Linda King Ian Hamilton Jay Levine Armando Oliva Joe Salewski Susan Howard Frank Jensen John Speakman Harry Greenspun Mitra Rocca Mathias Poensgen Tina Hartikainen Daijin Kim Miguel Valenzuela 10/7/2020 Astellas US LLC Bayer Healthcare, Pharmaceuticals Boehringer Ingelheim Pharmaceuticals Bristol Myers Squibb Cerner Corporation (EHR vendor) Clin. Phone Inc (Clinical technology vendor) Eli Lilly & Company FDA FDA Glaxo Smith. Kline Pharmaceuticals Lundbeck Pharmaceuticals, EFPIA NIH / Cancer Research Foundation Northrop Grumman Health Solutions Novartis Pharmaceuticals Nycomed Gmb. H Orion Pharmaceuticals Pfizer Pharmaceuticals Roche Products Limited Copyright EHR/CR Project 11

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