BRIDG Update HL7 Working Group Meeting Lake Buena Vista, FL 17 May, 2011

2 Agenda BRIDG Overview Recent Accomplishments Current Efforts Next Steps

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 semantic coordination committee consults with projects and harmonizes project models into main model with help of project analysts/SMEs

4 Recent Accomplishments Released BRIDG December, 2010 Balloted BRIDG as ISO JIC Standard in May, 2010 – BRIDG passed both HL7 and ISO ballots – Currently in the next round of balloting, responding to suggested changes from ISO HQ Started a BRIDG SMEs group – Experts who help SCC vet new/modified semantics

BRIDG Release Changes HL7 Integrated Case Safety Report (ICSR) Release 2 CDISC Study Data Tabulation Model (SDTM) Implementation Guide v3.1.2 CDISC Clinical Data Acquisition Standard Harmonization (CDASH) v1.1 ISO Joint Initiative Council (JIC) ballot – remainder of ballot changes/issues resolved 5

6 ReleaseProjects Harmonized with BRIDG as of Dec., 2010Stakeholder 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 OrgNCI, 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 CmtsHL7 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 3.1.2, CDASH, TDM, CDISC, DAM, ISO JIC Ballot CommentsCDISC HL7 ICSR MessageFDA, HL7

7 Current Efforts Re-harmonization of HL7 Study Design Message Harmonization of CDISC Operational Data Model – Study Design Model (ODM-SDM) Re-harmonization of HL7 Study Participation Message Harmonization of MD Anderson/Nat’l Marrow Donor Program (NMDP) Hematopoietic Cell Transplantation (HCT) project – Will add bone marrow/stem cell transplant concepts to BRIDG Updating BRIDG website and process documentation Genzyme’s RegistryNXT! – Will add rare disease registry concepts to BRIDG Nat’l Center for Research Resources’ Clinical and Translational Science Award (CTSA) Human Studies Database (HSDB) project

8 Next Steps Also in the summer: – Harmonization of FDA’s Observational Medical Outcomes Partnership (OMOP) model – HL7 CTR&R re-harmonization – NCI’s Clinical Trials Reporting Program (CTRP) re- harmonization Fall: – Harmonization of CDISC Statistics model – Harmonization of more Hematopoietic Cell Transplantation (HCT) concepts

9 BRIDG Project Home Page – SCC Contact Listserv – BRIDG Users Listserv – RCRIM: BRIDG as a DAM Listserv – Contact Information

10 Q & A

Back up slides 11

12 BRIDG Board of Directors 12 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

13 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 Mike WoodcockNCI / Mayo Clinic