eSource, EMEA London, June 2006
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  • 1. eSourceJune 7, 2006.EMEA, LondonDave Iberson-Hurst, AsseroCo-lead, CDISC eSDI Group© Assero Ltd & CDISC, 2006
  • 2. Agenda CDISC Background Method & Analysis User Requirements Scenarios Benefits Next Steps SummaryEMEA. June 7th, 2006 2
  • 3. The CDISC Mission Clinical Data Interchange Standards Consortium The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.EMEA. June 7th, 2006 3
  • 4. CDISC Organisation CDISC Coordinating Committee CDISC Board Committees Leaders, Japan & Europe Board of Directors • Executive • Financial Oversight • GovernanceIndustry Advisory Board • Global Strategy • Global Communications President Global Operations Board and IAB Support International Operations Support Member Services New Opportunity Exploration PR/Communications Program Management Business Case Alliance Management Website/IT; Interchanges Member Services Technical Advisory CommitteeProduction Standards Implementation Services Innovation Initiatives•  Production Standards Updates •  Education Courses •  BRIDG Modeling (SDTM, SEND, define.xml, ODM, •  Global User Network Support •  SDTM-ADaM Pilot LAB, ADaM, Glossary) •  Regional CDISC Coordinating Comm. •  Submission in ODM XML•  End-to-end Documentation (Japan, Europe) •  eSource Data Interchange•  Implementation Guide/Std •  U.S. Networks •  Terminology and NIH Grants Enhancement (e.g. TDM, PK, •  Implementation Enablers ( proto- •  Protocol Representation device, vaccine) tools ) •  Healthcare Link •  Help Desk •  Industry Architecture Proposal EMEA. June 7th, 2006 4
  • 5. History CDISC Volunteer CDISC CDISC SDTM into Group Europe Japan guidance DIA SIAC CDISC Define.XML Formed Incorporated guidance 1997 1998 1999 2000 2001 2002 2003 2004 2005 ODM V1.1 LAB V1.0 ODM V1.2 ODM V1.0 SDS V2.0 SDS V3.0 SDTM V1.0 (*) (*) (*) * Note: SDS became SDTMEMEA. June 7th, 2006 5
  • 6. Standards CRO SponsorInvestigator Subject LABsEMEA. June 7th, 2006 6
  • 7. Standards CRO Sponsor ODM Archive ODM SDTM ODM ADaMInvestigator ODM Define.XML Archive Subject LABs ProtocolEMEA. June 7th, 2006 7
  • 8. Operational Data Model CRO Sponsor ODM Archive ODM SDTM ODM ADaMInvestigator ODM Define.XML •  Exchange & Archive of clinical data Archive Subject •  Production Version 1.2.1 LABs •  Protocol XML SchemaEMEA. June 7th, 2006 8
  • 9. Laboratory Data Model CRO Sponsor ODM Archive ODM •  Exchange of LAB data SDTM ODM ADaM •  Production ODMInvestigator Version 1.0.1 Define.XML •  Implementations through SAS, Archive ASCII, XML/ODM Subject LABs and HL7 V3 RIM Protocol messageEMEA. June 7th, 2006 9
  • 10. Study Data Tabulation Model CRO Sponsor ODM Archive ODM SDTM•  Submission data (Case Report ODM ADaM Tabulations; analysis data)Investigator ODM Define.XML•  Production Version 1.1•  Referenced as a specification in Archive FDA Guidance - 21 July 2004 Subject LABs ProtocolEMEA. June 7th, 2006 10
  • 11. Standards for the Exchange of Non-clinical Data (SEND) CRO Sponsor ODM Archive ODM •  Non-clinical (animal) data SDTM ODM ADaM •  Based upon CDISC SDS V3.1Investigator ODM •  Included in SDTM model now Define.XML referenced in FDA Guidance Archive Subject LABs ProtocolEMEA. June 7th, 2006 11
  • 12. Analysis Dataset Models CRO Sponsor ODM Archive ODM •  General Considerations Document and Examples of ODM SDTM ADaM Standard Analysis Datasets ODMInvestigator for Submissions Define.XML Archive Subject LABs ProtocolEMEA. June 7th, 2006 12
  • 13. Protocol Representation CRO Sponsor ODM Archive ODM SDTM ODM ADaM •  HL7-CDISC-NCI CollaborationInvestigator ODM •  Objective to develop a standard, Define.XML structured, machine-readable clinical Archive protocol representation Subject LABs ProtocolEMEA. June 7th, 2006 13
  • 14. Terminology CRO Sponsor ODM Archive ODM SDTM ODM ADaMInvestigator ODM Define.XML •  Covers the work of all teams Archive Subject LABs ProtocolEMEA. June 7th, 2006 14
  • 15. CDISC Projects - A Sample•  End-to-End Production Use –  How are the models used end-to-end in detail•  Device Domain –  SDTM Domain•  SDTM-ADaM Pilot –  In conjunction with the FDA•  Submission in ODM XML –  Removal of SAS Transport Files•  The Link with Healthcare –  Integrating the Healthcare Enterprise (IHE) ProfileEMEA. June 7th, 2006 15
  • 16. Background•  FDA Presentation, August 2004 - Reviewers –  Operational Data Model (ODM) –  The Archive Use Case –  Define.xml•  FDA Presentation, November 2004 - DSI –  ODM –  Regulations•  Suggested changes to CSUCT guidance documentEMEA. June 7th, 2006 16
  • 17. eSDI Group •  The electronic Source Data Interchange (eSDI) initiative •  Started in November 2004 with the encouragement from the Food and Drug Administration (FDA)EMEA. June 7th, 2006 17
  • 18. eSDI Mission Produce a document that would benefit industry and FDA by providing recommendations for the use of the CDISC standards with associated processes that can promote the enhanced use of eSDI within the context of the existing regulations for regulated clinical research.EMEA. June 7th, 2006 18
  • 19. Issues•  How to transition from the paper world to the e-World in terms of audits, reviews, compliance to regulations•  No regulatory basis for Trusted Third Parties•  Concern about Interim Analysis•  Collection of data without adequate psychometric validation•  Inadequate validation and control of systems used for data collectionEMEA. June 7th, 2006 19
  • 20. History•  Expert Focus Groups Invited for Comment –  23rd February, Philadelphia –  7th March, Lisbon•  1st Draft 14th March 2005 –  4th & 5th April, DIA ePRO Conference, Arlington –  11th April, SAS Users Forum•  2nd Draft 25th May 2005•  3rd Draft 11th August 2005•  4th Draft 29th August 2005•  5th Draft 16th September 2005•  500+ individual comments•  6th Draft Q2 2006EMEA. June 7th, 2006 20
  • 21. Content•  Psychometric validation not in document –  Now being looked at by a DIA group•  Interim Analysis –  Small reminder of current regulations and guidance•  eSource –  Main focus of document –  How standards can helpEMEA. June 7th, 2006 21
  • 22. Motivation and Aims•  Motivation –  Desire to solve the issue and increase adoption•  Aims –  Something tangible to shoot at, detailed enough to allow debate and be practical –  Simple check list, well understood (a what not how) –  Allows all stakeholders (FDA, Sponsors, Vendors & Investigators) to assess current and future technologiesEMEA. June 7th, 2006 22
  • 23. Method•  Examine the paper process; if well executed, it meets the regulatory requirements•  What are the requirements that source documents must meet?•  What do the FDA, Sponsors and Investigators need (key requirements) from source documents?•  Consider –  Regulations –  Data Quality & Integrity –  Subject SafetyEMEA. June 7th, 2006 23
  • 24. Outcome•  Checklist –  A checklist that allows industry to assess any technology and process now or in the future•  Scenarios –  Suggested ways to move forwardEMEA. June 7th, 2006 24
  • 25. Criticism of Approach•  Criticisms –  We don’t want to preserve paper –  Why look at the paper process•  Fundamental Question –  Why do we have source documents and data?EMEA. June 7th, 2006 25
  • 26. Fundamental Questions•  How do we ensure that the data submitted are the data captured?•  How do we ensure the data captured is accurate?•  How do we ensure the subjects safety?EMEA. June 7th, 2006 26
  • 27. User Requirements•  12 in total•  As they stand today•  Open for review, discussion and debate•  The detail is in the white paper•  All are mapped to regulationsEMEA. June 7th, 2006 27
  • 28. Requirement 1 (Old Text) An instrument used to capture source data shall be an accurate representation of the protocol ensuring that the data as specified within the protocol is captured correctly.EMEA. June 7th, 2006 28
  • 29. Requirement 1 (New Text) An instrument used to capture source data shall ensure that the data is captured as specified within the protocolEMEA. June 7th, 2006 29
  • 30. Requirement 2 Source data shall be Accurate, Legible, Contemporaneous, Original, Attributable, Complete and Consistent (the ALCOA and Data Integrity requirement).EMEA. June 7th, 2006 30
  • 31. Requirement 3 An audit trail shall be maintained as part of the source documents for the original creation and subsequent modification of all source data.EMEA. June 7th, 2006 31
  • 32. Requirement 4 The storage of source documents shall provide for their ready retrieval.EMEA. June 7th, 2006 32
  • 33. Requirement 5 The investigator shall store the original source document or a certified copy.EMEA. June 7th, 2006 33
  • 34. Requirement 6 The mechanism used to maintain source documents shall ensure that source data cannot be modified without theknowledge or approval of the investigator.EMEA. June 7th, 2006 34
  • 35. Requirement 7 Source documents and data shall be protected from destruction.EMEA. June 7th, 2006 35
  • 36. Requirement 8 The source document shall allow for accurate copies to be made.EMEA. June 7th, 2006 36
  • 37. Requirement 9 Source documents shall be protected against unauthorised access.EMEA. June 7th, 2006 37
  • 38. Requirement 10 The sponsor must never have exclusive control of a source document.EMEA. June 7th, 2006 38
  • 39. Requirement 10 The sponsor must never have exclusive control of a source document. “Comments were also made indicating that this was not a new requirement, but intrinsic to complying with FDA regulations regarding clinical trials.”EMEA. June 7th, 2006 39
  • 40. PRO Guidance Document•  FDA Guidance for Industry. –  Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims•  Lines 848 & 849 –  Sponsors should also plan to avoid the following: •  Direct PRO data transmission from the PRO data collection device to the sponsor (i.e., the sponsor should not have exclusive control of the source document)EMEA. June 7th, 2006 40
  • 41. Requirement 11 The location of source documents and the associated source data at all pointswithin the capture process shall be clearly identified.EMEA. June 7th, 2006 41
  • 42. Requirement 12 (Old Text) When source data are copied, the process used shall ensure that the copy is an exact copy having all of the same attributes and information as the original.EMEA. June 7th, 2006 42
  • 43. Requirement 12 (New Text) When source data are copied, the process used shall ensure that the copyis an exact copy preserving all of the data and metadata of the originalEMEA. June 7th, 2006 43
  • 44. Recommendations (1)•  Source at Site –  Electronic equivalent of paper –  Must be easy (practical) for the investigator –  The CDISC Operational Data Model (ODM) can assist greatly Source Data Investigator ODM Sphere of investigator Sponsor controlEMEA. June 7th, 2006 44
  • 45. Recommendations (2) •  eSource System Provider –  Works on behalf of the investigator –  Must document how the 12 core requirements are met –  This document must be open to inspection by the FDA Investigator eSource System Provider SponsorEMEA. June 7th, 2006 45
  • 46. Recommendations (3)•  Single Source Concept Sponsor Sponsor Database –  Single entry of data using an EHR –  Data used, as required, in both healthcare and clinical research ODM –  Use of “ODM Store” helps facilitate compliance with the Source regulations EHR Data ODMEMEA. June 7th, 2006 46
  • 47. Recommendations (4)•  EHR Extraction and Sponsor Sponsor Investigator Verification Database –  Data extracted from the EHR database –  Investigator verifies the data –  Protects against 21 CFR 11 “creep” EHR EHR DatabaseEMEA. June 7th, 2006 47
  • 48. Recommendations (5)•  Direct Extraction Sponsor Sponsor –  Data extracted from the Database EHR database –  EHR must be 21 CFR Part 11 Compliant EHR Database EHREMEA. June 7th, 2006 48
  • 49. Next Steps - The Ideal Picture? eSource System Provider Investigator Sponsor Source DocEMEA. June 7th, 2006 49
  • 50. Next Steps - The Ideal Picture? eSource System Provider •  Read •  Create •  Read •  Update Investigator Sponsor Source Doc •  Read •  Update With ApprovalEMEA. June 7th, 2006 50
  • 51. Fundamental Questions•  How do we ensure that the data submitted are the data captured?•  How do we ensure the data captured is accurate?•  How do we ensure the subjects safety?EMEA. June 7th, 2006 51
  • 52. Output From Work•  12 User Requirements•  5 Scenarios•  Recommendations•  Checklist for Investigators•  Sponsor Audit Report TemplateEMEA. June 7th, 2006 52
  • 53. Summary•  The work of the eSDI group provides a clear way forward in the use of eSource•  Core requirements and recommendations provide the foundation stone for the building of true e-Clinical systems•  Draft 6 being worked on, will be released via the CDISC website, www.cdisc.orgEMEA. June 7th, 2006 53
  • 54. Information and Contacts•  eSDI Group Leaders –  Rebecca Kush rkush@cdisc.org –  Dave Iberson-Hurst dave.iberson-hurst@assero.co.ukEMEA. June 7th, 2006 54
  • 55. Contributors•  Ethan Basch •  Michael Noonan Memorial Sloan-Kettering Cancer Asthma Research Center •  Lisa Olson•  Peter Black SEC Associates Scirex •  Shaghig Palanjian•  David Detoro Perceptive Informatics Schering Plough •  Jay Pearson•  Hugh Donovan Merck & Co. Siemens •  David Reasner•  Greg Fromell Sepracor University of Pennsylvania •  Dana Stone•  Ed Helton Merck & Co. SAS •  Mark Weiner•  John Jordon University of Pennsylvania Schering Plough •  Wallace Wormley•  Suzanne Markel-Fox University of Pennsylvania GSKEMEA. June 7th, 2006 55
  • 56. FDA Liaisons•  Laurie Burke Director Study Endpoints and Label Development, Office of New Drugs CDER•  Joanne Rhoads Director, Division of Scientific Investigations, CDER•  Joe Salewski Deputy Director, Division of Scientific Investigations, CDER•  Jane Scott Study Endpoints and Label Development, Office of New Drugs, CDER•  Steve Wilson Deputy Director, Division of Biometrics II, CDEREMEA. June 7th, 2006 56
  • 57. DiscussionEMEA. June 7th, 2006 57