1. HL7 EHR Clinical Research Functional Profile Linda King 1, Mitra Rocca 2 1.Eli Lilly and Company 2.Novartis Pharmaceutical Corporation 15 January 2009 Orlando, Florida eClinical Forum and PhRMA EDC/eSource Taskforce Richard Perkins, Catherine Celingant, Suzanne Bishop

2. Outline Overview of the HL7 EHR Clinical Research Profile Certification Commission for Health Information Technology (CCHIT) & Clinical Research Status of EU- Clinical Research Functional Profile Mapping Normative Ballot Reconcilation 2

3. Project Sponsors & Participants Global Participants: Bayer Boehringer Ingelheim Bristol Myers Squib Cerner Corporation ClinPhone Inc. Eli Lilly and Company * FDA Glaxo SmithKline * Hoffman La Roche * Lundbeck Millennium National Cancer Institute Northrop Grumman Novartis Pfizer * Procter & Gamble * * Gold Level Members Sponsors: In Cooperation With: HL7 EHR & RCRIM Workgroups CDISC EDC/eSource Task Group

4. EHR CR Project Overview 4 Develop a Global EHR/Clinical Research Functional Profile (EHRCR-FP) Identify critical requirements for clinical research utilizing EHR systems through: – Expansion of the HL7 EHR FM R1 to include clinical research requirements – Providing the profile to both CCHIT and EUROREC Outcomes: EHR Vendors: provide with requirements for incorporating clinical research functions into their systems Research Sponsors: provide basis for evaluating EHR systems as source data systems Healthcare: Understand operational functionality required for clinical research Regulators: gain confidence in the reliability of EHR systems as source for clinical research data

5. HL7 EHR Clinical Research Background HL7 EHR Clinical Research Functional Profile passed the HL7 May 2008 ballot cycle (Informative) HL7 EHR Clinical Research Functional Profile team are interested in having this profile accepted as a normative standard. HL7 EHR Clinical Research Functional Profile in Jan. 2009 Ballot Cycle 5

6. Electronic Health Records for Clinical Research Status Report on CCHIT

7. CCHIT & Clinical Research Created a multi-stakeholder planning committee in order to get on the Certification Commission for Health Information Technology (CCHIT) Roadmap Submitted a joint (ANSI, AHIMA, HL7, CDISC, eClinical Forum/PhRMA, HIMSS/EHRA, NCI) environmental data scan form on Dec. 31, 2008 to CCHIT to consider Clinical research on their 2010 roadmap 7

8. Electronic Health Records for Clinical Research Status Report on submission of EHRCR Functional Profile to EUROREC

9. Approach 9 Global Clinical Research User Requirements… User Requirement Tier 1 (Core) Relevance Regulatory Link System and Data Security Requirements System shall have an audit trail to include recording date/time/author of any data creation, change, or deletion CSUCI: D2b, D2c, D2f, D2g Part 11: 11.10 e ICH GCP: 4.9.3, 5.5.4 21 CFR: 312.62 … and reason … Essential Optional (future) International Regs International Regulations Conformance Criteria HL7 EHRCR FP IN.2.2 Auditable Records Criteria 3,4,8,9,15 Conformance Criteria EuroRec EHRCR FP GS002183.02 The audit log contains create/edit/ deleted events. GS002188.01 Audit log records include date and time of recordable events. GS002191.01 An audit log record includes the user identity associated with a recorded event. GS002192.01 An audit log record contains the outcome status of a recorded event. HL7 EHRs-FM Conformance Criteria …Mapped to Existing Criteria + New Criteria Needed to Meet Clinical Research Needs EuroRec Fine Grained Statements + New Criteria Needed to Meet Clinical Research Needs

10. Status: EHRCR Profile to EuroRec Several face-to-face meetings with EuroRec (contact: Jos Devlies) Mapping & Submission materials almost complete EuroRec has provided us with an online tool to specify the subset of fine-grained statements that will become the EHRCR functional profile Submission of complete profile, including additional research-related fine-grained statements, expected by end 1 st Qrt. 2009

11. 11 Addressing Negative Ballot Comments

12. CDISC CDASH 1.There were 28 conformance criteria referencing CDISC CDASH Version 1 12 CDISC CDASH Non-CDASH Related comments Total No. of Affirmatives with Comments 83745 No. of Negatives with Comments 47653

13. Examples from Other EHR Functional Profiles 1.Child Health Profile The system SHALL capture patient vital signs, including weight, height or length, head circumference, blood pressure, temperature, heart rate, respiratory rate, and severity of pain as discrete elements of structured or unstructured data. 2. Behavioral Health Functional Profile The system SHALL provide the ability to validate clinical terms and coded clinical data against nationally recognized, standard terminologies including the Diagnostic and Statistical Manual (DSM). 13

14. Examples from Other EHR Functional Profiles 3. Long Term Functional Profile The system SHALL provide the ability to capture specialized medical equipment and each prosthetic, orthotic, or implantable device as unique, discrete entries. 4. Personal Health Record (PHR) FM The system SHALL provide the ability to capture information related to allergy, intolerance, and adverse reaction to drug, dietary or environmental triggers as unique, discrete entries. 14

15. CDISC CDASH Example Before: The system SHALL collect a minimum set of Medication data as modeled by CDISC CDASH Release 1 highly recommended data elements for this domain After: Use EHR FM Existing Criteria and add one criteria to handle Therapy details: The system SHALL provide the ability to capture details of a therapy, including therapy name, start and stop dates CDASH will be referenced only in the introduction. 15

16. 16 Thank you! Questions? Linda King King_Linda_S@Lilly.com Mitra Rocca Mitra.rocca@novartis.com

17. 17 Backup

18. Mapping in Progress 11-Feb-14Copyright EHR/CR Project 2007 18 Categories of Relevance Core – must have to meet minimum requirements Future – future need or nice to have Maybe – needs discussion Not relevant – not relevent now or ever New – a new criteria being proposed by EHRCR to meet Clinical Research User Requirements Categories of Relevance Core – must have to meet minimum requirements Future – future need or nice to have Maybe – needs discussion Not relevant – not relevent now or ever New – a new criteria being proposed by EHRCR to meet Clinical Research User Requirements

19. EuroRec EHRCR Approach and Plan 1.Kick-off Team Meeting – June 11, 2008 2.Map our Clinical Research user requirements to the EuroRec repository – Completed 1 st round Aug. Currently refining and assessing criteria to be added 3.Work out a process for how the resulting profile could be used and how it fits with labeling plans for EHR being developed by EuroRec – Oct, 2008 (at eCF meeting) 4.Develop a submission to EuroRec for approval of our EU Clinical Research profile – Outline developed, Oct, 2008 5.Identify additional criteria (draw from HL7 EHRCR Functional Profile standard) to submit to EuroRec for inclusion in the repository – 4Q, 2008 6.Finalize mapping to User Requirements and HL7 EHRCR profile post HL7 ballot reconciliation – Jan, 2009 7.Provide new fine-grained statements as an uploadable file for implementation within the EuroRec repository – Feb, 2008 8.Use the EuroRec-supplied online tool to subset the EHRCR Profile. – Feb, 2008 9.Do a mock assessment against a commercial EHR system to see what the gaps are – 1Q 2009 10.Communicate with stakeholders (who, what, when, how) – 1Q 2009 11.Refine the EuroRec EHRCR FP based on mock assessment and stakeholder feedback – 2Q 2009 19