1. BRIDG Update HL7 Working Group Meeting San Diego, California 13 September 2011 Tuesday Q2, 11-12:30

2. 2 Agenda BRIDG Overview Recent Accomplishments Current Activities Project Scope Statement Update Next Steps

3. 3 BRIDG Overview BRIDG Purpose: A collaborative effort to produce a shared view of the dynamic and static semantics that collectively define a shared domain-of-interest. Domain-of-interest/scope: Protocol-driven research and its associated regulatory artifacts, i.e. the data, organization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, subject characteristic, biologic, cosmetic, food or device on a human, animal, or other subject or substance plus all associated regulatory artifacts required for or derived from this effort, including data specifically associated with post-marketing adverse event reporting. Stakeholders: Process: Board of Directors prioritizes projects and committee consults with projects and harmonizes project models into main model with help of project analysts/SMEs

4. 4 Recent Accomplishments Harmonization of Hematopoietic Cell Transplantation (HCT) data elements (4 sets of 8) Harmonization of NCI Case Report Form (CRF) Standard Rounds 1 & 2 Harmonization of Nat’l Center for Research Resources’ Clinical and Translational Science Award (CTSA) Human Studies Database (HSDB) project – almost complete Began discussions with OMOP project regarding harmonization Development and posting of BRIDG Harmonization Package

5. 5 ReleaseProjects Harmonized with BRIDGStakeholder R1.0: Jun., ‘07Regulated Product Submission (RPS)FDA/HL7 RCRIM Patient Study Calendar (PSC)NCI Clinical Trial Object Model (CTOM)NCI caXchange/LabHubNCI/HL7 RCRIM TC/CDISC R1.1: Oct., ‘07Study Data Tabulation Model (SDTM)CDISC Trial Design ModelCDISC R2.0: Jun., ‘08Adverse EventsCDISC, NCI, NIH, US Federal Gov’t, FDA Player / Scoper for Person and OrganizationNCI, CDISC Patient Registry (C3PR)NCI R2.1: Oct., ‘08Clinical Trial Registry (COPPA, ct.gov, WHO, PRV1.0)CDISC, NCI Protocol Abstraction (COPPA – Correlations, Organizations, People and Protocol Abstraction) NCI R2.2: May, ‘09CDISC HL7 Message Study Design (partial)FDA CDISC HL7 Message Study ParticipationFDA R3.0: Oct., ‘09(Architecture Redesign only) R3.0.1: Feb., ‘10Clinical Trials Registration & Results, CDISC Ballot CommentsHL7 RCRIM, CDISC R3.0.2: Aug., ’10Central Clinical Participant Registry (C3PR)NCI caBIG Adverse Event Reporting System (caAERS)NCI LabViewer (LV)NCI Patient Study Calendar (PSC)NCI ISO Ballot Comment Responses (part 1)CDISC R3.0.3: Dec., ‘10SDTM v3.1.2, CDASH v1.1, TDM, ISO JIC Ballot CommentsCDISC HL7 ICSR MessageFDA, HL7

6. 6 Current Efforts Harmonization of MD Anderson/Nat’l Marrow Donor Program (NMDP) Hematopoietic Cell Transplantation (HCT) project - Remaining 4 of 8 sets – Will add bone marrow/stem cell transplant concepts to BRIDG Genzyme’s RegistryNXT! – Will add rare disease registry concepts to BRIDG Harmonization of NCI’s CRF Project – Remaining 2 of 4 rounds Harmonization of CDISC Operational Data Model – Study Design Model (ODM-SDM) Updated harmonization of FDA’s HL7 Study Participation message Re-harmonization of HL7 Study Design Message Internal efforts – Moving from gforge to Jira for project tracking – Updating BRIDG website ISO Ballot Status – RCRIM ballot reconciliation – Next round of balloting in ISO JIC Ballot

7. 7 RCRIM Ballot Reconciliation Ballot reconciliation spreadsheet sent to RCRIM on 8-Sept- 2011. Need to vote on accepting the package. – Julie to get confirmation from Gunther on negative major that was non-persuasive. – Vote will be scheduled for tc after confirmation.

8. 8 ISO Ballot Status The ISO Central Secretariat sent comments to the BRIDG team regarding the BRIDG JIC ballot. The BRIDG team responded with proposals to address each comment. CDISC is now working with the new ISO TC 215 Technical Program Manager to confirm that our proposals will meet the ISO requirements. We expect to have an answer around the end of September. Next round of ISO Balloting – need 6 months lead time – 1 month for ISO HQ to review/prepare ballot and 5 months for the Draft International Standard (DIS) ballot. No set balloting schedule in ISO, but we try to align with a TC 215 Spring or Fall meeting so the ballot can be discussed in person. The HL7 ballot needs to end at the same time as the ISO ballot. Proposed ballot dates: – ISO ballot opens October 2011; closes by end of April 2012 – HL7 ballot opens April 2012 for May ballot

9. 9 BRIDG as a DAM Scope Stmt BRIDG Harmonization Schedule Standard or Planned MessageRCRIM Status Currently in BRIDG? Date to Ballot in BRIDG ISO JIC Ballot, including HL7 ballotNot applicableNAMay 2012 ANSI/HL7 Regulated Product Submission, R1-2008Approved NormativeYes HL7 CDISC to HL7 Message Study Design, R1Current ProjectNoMay-2013 HL7 CDISC to HL7 Message Study Participation, R1Current Project Yes, but updatesMay-2012 Periodic Reporting of Clinical Trial Laboratory Data, Release 2WithdrawnNA Laboratory Test Result Abnormality AssessmentApproved DSTUYes HL7 CDISC to HL7 Message Subject Data, R1Current ProjectNoMay-2013 Clinical Trial Registration and Reporting (CTR&R), R1DSTUYesMay-2012 HL7 Version 3 Standa rd: Regulated Product Submission, R2Current ProjectNoMay-2013 ANSI/HL7 V3 ECG, R23 year planNoMay-2013 HL7 Drug Stability Reporting (eStability), R2NormativeNoMay-2013 HL7 Structured Product Label, R5DSTUNoMay-2013 HL7 V3 CRFQ,R1 (extended DSTU – part of a trial, but DSTU expires before the trial does – will reballot in Jan 2012 to get it re- affirmed as DSTU Release 2 with no changes)Approved DSTUNoMay-2013 Clinical Trial Registration and Reporting (CTR&R) R23 year planNoMay-2014

10. 10 BRIDG as a DAM Harmonization Process Document BRIDG SCC has new Harmonization Package, including BRIDG Harmonization Process document RCRIM has a BRIDG Harmonization Process and Procedures document, which has redundant information Proposal: Update RCRIM document to refer to new BRIDG document, keeping RCRIM-specific content in the RCRIM document.

11. 11 Next Steps Fall: – Harmonization of CDISC Statistics model – Continue harmonization of Hematopoietic Cell Transplantation (HCT) concepts – Continue harmonization of NCI CRF Standard – Call for BRIDG BoD nominations Winter: – Publish next release of BRIDG in December – BRIDG BoD election

12. What to do with these DAMs in RCRIM Ballot? HL7 Study Design DAM HL7 Study Participation DAM We need to remove these DAMs from the ballot and point people to BRIDG since the DAMs are out of date and the updated semantics are in BRIDG: – How do we tell people where to look in BRIDG? It’s too big. We need project specific views of BRIDG. – Proposed Solution: Project teams create a project subset of BRIDG at the beginning of a project and also at each release. These project specific views will be part of the project ballot. If BRIDG changes, we don’t change project view unless a new release of the project comes along. Need to update RCRIM BRIDG harmonization document with these instructions – Motion to withdraw SD and SP DAMs from RCRIM ballot – motion carries 12

13. 13 BRIDG Project Home Page – www.bridgmodel.org www.bridgmodel.org SCC Contact Listserv – bridgTHC-L@list.nih.gov bridgTHC-L@list.nih.gov BRIDG Users Listserv – BRIDG_USERS@list.nih.gov BRIDG_USERS@list.nih.gov RCRIM: BRIDG as a DAM Listserv – bridg@lists.hl7.org bridg@lists.hl7.org Contact Information

14. 14 Q & A

15. Back up slides 15

16. 16 BRIDG Board of Directors 16 Appointed MembersStakeholder Charlie MeadNCI Bron KislerCDISC Chuck JaffeHL7 Jonathan LevineFDA At Large MembersTerm Expiration Jack Jones2011 Becky Kush*2011 Cecil Lynch2012 AbdulMalik Shakir2012 Sue Dubman2013 John Speakman2013 Diane Wold2013 * Chair Mitra RoccaFDA Ex Officio

17. 17 Semantic Coordination Committee NameAffiliation Charlie MeadNCI Becky AngelesNCI / ScenPro, Inc. Smita HastakNCI / ScenPro, Inc. Steve SandbergNCI / ScenPro, Inc. Wendy Ver HoefNCI / ScenPro, Inc. Julie EvansCDISC Lloyd McKenzieNCI / Gordon Point Informatics