1. 1 Electronic Data Capture Healthcare perspective 1 INSERM, U872 team20, Paris Descartes University, France 2 AP-HP,Hôpital Georges Pompidou,Paris,France 3 Sanofi-aventis R&D and CDISC Board of Directors C.Daniel 1, 2, N. El Fadly 1, C.Bousquet 2, N.Lucas 2, P-Y. Lastic 3, P.Degoulet 1, 2, G.Chatellier 2

2. 2 Secondary use of clinical data Can EHR replace the need for eCRF? What is the impact on the investigator or monitor roles? What is the impact on: Physicians/Nurses roles IT staff role How should the interaction model change between clinical care and clinical research actors to accelerate usage of IT solutions? And secondary usage of clinical data?

3. 3 Context : AP-HP Patient care Most important French University Hospital Organization with 1,000,000 hospitalized patients 38 hospitals with round 23,000 beds + 1400 day care and 850 home care capacity 90,000 employees including 19,000 physicians Single HIS/EHR: CareByThales® (Thales©) (2009) EHR EHR Clinical information Nurse notes Discharge summaries, DRGs Flow sheets, Care plans Medical order Imaging reports Lab results Patient focus (Point-of-Care)

4. 4 Context : AP-HP Medical research Medical Research is carried out in 18 Research Institutes, 8 Clinical Investigation Centers (phase I & IIa, PK/PD, etc.) and 10 Clinical Research Units 100 INSERM teams eCRF provider : ClinWeb® (TelemedicineTechnologies©) Clinical Trials Population focus (Retrospective)

5. 5 EHR Clinical Trials Clinical Research Patient Safety EHR Adapted from E.D.Helton (HL7 RCRIM Co-Chair) & L.Bain (CDISC Liaison to Healthcare) Context and problems Patient focus (Point-of-Care) Population focus (Retrospective) Multiple applications Multiple data forms => Redundant data entry

6. 6 Integrating Patient Care & Clinical Research at HEGP Development and deployment of IT in CRU With respects to standards (HL7, CDISC) Secondary use of clinical data? Collaboration Clinical Research Unit (Pr G.Chatellier – Dr N.Lucas) Hospital Informatics Department (Pr P.Degoulet – Dr C.Daniel) INSERM UMRS 872 eq 20 (M-C.Jaulent) THALES (middleware solutions) 2 persons PhD student – THAKES Engineer

7. 7 Our strategy Understanding each other’s needs Clinical Research needs Patient Care needs Understanding existing standards (HL7, CDISC, IHE RFD, etc) Iterative and incremental integration process Use case driven : use cases capture the functional requirements and define the contents of the iterations Standard-based (HL7, CDISC) Syntactic alignment (HL7/CDA to CDISC/ODM) avoids double data entry, based on XForms

8. 8 Understanding “Clinical Research (CR)” needs Actors Actors of Clinical Research Sponsor Clinical Research Coordinator (CRC) Monitor Principal investigator / Physician Clinical trial technician Data manager IT staff Newly involved in secondary uses of clinical data –Feeding clinical data repositories, registries, datawarehouses

9. 9 Understanding CR needs Use cases Use cases of Clinical Research Clinical trial coordination Clinical trial design (including EDC solution design) Patient recruitment Data capture (patient care/clinical research) Data monitoring Safety monitoring Databases and interfaces administration

10. 10 Understanding CR needs Comparing workfows with/without EHR Integrating EHR (DxCare) & eCRF Using eCRF (CleanWeb) Use cases of clinical trial coordination

11. 11 Understanding CR needs Comparing workfows with/without EHR Integrating EHR (DxCare) & eCRF Using eCRF (CleanWeb) Use cases : patient scheduling, data capture, etc

12. 12 Understanding CR needs Interaction diagrams Data capture during the visit

13. 13 Understanding CR needs Interaction diagrams Patient care/clinical research interface management

14. 14 Understanding “Patient Care” needs Integrating the eCRF to EHR Providing a method for gathering data within a user’s application to meet the requirements of an external system Data could be automatically extracted from the EHR database The form (for the external system) is designated as a clinical trial form and saved as a document in the patient’s record. EHR

15. 15 EHR Clinical Trials/Patient safety/ Governmental agencies EHR Patient focus (Point-of-Care) Population focus (Retrospective) Alerts Decision Support system Chris Clinician Samuel Sponsor Chris Clinician Patricia Pharmacovigilant Carolyn Clinician Franck FBI Understanding “Patient Care” needs

16. 16 Understanding “Patient Care” needs Providing methods for gathering data within a user’s application to meet the requirements of BOTH external systems AND EHR » EHR is not only a « host application » SHARING medical data for both patient care (EHR) and clinical research

17. 17 Preliminary conclusions about needs Patient Care & Clinical Research : 2 different complex and parallel organizations and workflows (Kahn 2007) Redundancy Completion of the main record of a patient visit and transcribing patient information in the corresponding CRF for the clinical trial Patient safety Overlap between reporting forms or system(s) Avoiding reporting SAE to the sponsor before/instead of completing EHR Kahn S.A. A day in the life of a clinical research coordinator : observation from community practice settings. Medinfo 2007

18. 18 Conclusion Understanding workflows is critical to the design of the right IT solutions and their ultimate adoption Integrating Patient Care and Clinical Research “Integrating the Healthcare Enterprise” (IHE) Forum : users, IT vendors, academia –Definition of needs and of integrated workflows  Best use of existing standards (HL7, CDISC) (IHE “Integration Profiles”)  Compliance needs to be ensured (IHE Connecthatons) Specific IHE domain : Clinical Research