BRIDG Update HL7 Working Group Meeting Phoenix, Arizona 20 January 2010 Biomedical Research Integrated Domain Group

2 Agenda BRIDG Overview Accomplishments Next Steps HL7 Harmonization Use of RIM-based Model

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, or device on a human, animal, or other biologic subject or substance plus all associated regulatory artifacts required for or derived from this effort. 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 BRIDG Board of Directors 4 Appointed Members Charlie MeadNCI Dave Iberson-HurstCDISC Chuck JaffeHL7 Mitra RoccaFDA At Large MembersTerm Expiration Becky Kush2010 John Speakman*2010 Jack Jones2011 Cecil Lynch2012 AbdulMalik Shakir2012 * Chair

5 5 Semantic Coordination Committee NameAffiliation Charlie MeadNCI / Booz & Company Steve SandbergNCI / Mayo Clinic Smita HastakNCI / ScenPro, Inc. Wendy Ver HoefNCI / ScenPro, Inc. Becky AngelesNCI / ScenPro, Inc. Julie EvansCDISC Saurin MehtaCDISC / Novartis Jean DuteauNCI / Gordon Point Informatics Lloyd McKenzieNCI / Gordon Point Informatics

6 BRIDG Content ReleaseProjectStakeholder R1.0Regulated Product Submission (RPS)FDA/HL7 RCRIM Patient Study Calendar (PSC)NCI Clinical Trial Object Model (CTOM)NCI caXchange/LabHubNCI/HL7 RCRIM TC/CDISC R1.1Study Data Tabulation Model (SDTM)CDISC Trial Design Model CDISC R2.0Adverse EventsCDISC, NCI, NIH, US Federal Gov’t, FDA Player / Scoper for Person and OrgNCI, CDISC Patient Registry (C3PR)NCI R2.1Clinical Trial Registry (COPPA, ct.gov, WHO, PRV1.0)CDISC, NCI Protocol Abstraction (COPPA – Correlations, Organizations, People and Protocol Abstraction) NCI R2.2CDISC HL7 Message Study Design (partial)FDA CDISC HL7 Message Study ParticipationFDA R3.0(Architecture Redesign only) R3.1Clinical Trials Registration and ResultsHL7 RCRIM

7 Reasons for Redesign Subject matter expert (SME) perspective: – Missing domain words, too abstract – Broad scope is overwhelming for most SMEs HL7 expert perspective: – Developers find it difficult to unambiguously map to RIM – Varying degrees of abstraction and explicitness in different areas of the model

8 Approach for Release 3.0 Separate the domain-friendly UML-based model from a new, fully specified RIM-based model Divide UML model into topical sub-domains: – Common, Protocol Representation, Study Conduct, Adverse Event, Regulatory Improve UML model: – Update or simplify parts of model for clarity – Add tags to UML model elements to indicate source model element mappings – Clean up diagrams – business rules become constraints, better association labels, etc.

9 3 Layer Architecture 9 Future

10 Layer 2: UML-Based BRIDG Model Products and Study Agents Regulatory Specimens Organizations and their Roles People and their Roles Study Subjects Documents Studies Study Design Study Activities, Observations and Results Specimen Collection Adverse Events

11 Layer 1: AE Sub-Domain UML Model

12 Layer 3: RIM-Based BRIDG Model PORT_DM100002US Study Protocol (1 of 24 models) DocumentEvent ClinicalTrialIntent

13 RCRIM use of BRIDG

14 Semantic Coordination Process At beginning of a project, the project team should contact SCC via website listserv for BRIDG SCC at The SCC will assign a point of contact for the project. The SCC point of contact will answer BRIDG questions, consult with team about progress, schedule BRIDG harmonization, bring project issues to the SCC, etc. Project team representatives will attend the harmonization meeting(s) with the SCC

15 Improvements Needed in SCC Process Need to involve SCC earlier in project process Need to accelerate coordination / harmonization process Other ideas welcome 15

16 Accomplishments Released BRIDG 3.0 October 2009 BoD Elections Harmonized CTR&R Balloted as CDISC Standard

17 Next Steps Ballot as a Standard – HL7 May Ballot Cycle Notification of Intent to Ballot: February 28, 2010 Initial Content Deadline: March 7, 2010 Ballot Preview Period: March 14, 2010 – March 27, 2010 Content and Reconciliation Deadline: March 21, 2010 Final Content Deadline: March 28, 2010 Example Deadline: April 14, 2010 Balloting Period: April 5, 2010 – May 9, 2010

18 Next Steps (cont.) Ballot as a Standard – ISO Content Deadline: 29 January 2010 Balloting Period: 1 February 2010 – 1 May 2010 – CDISC Content Deadline: mid-February 2010 Balloting Period: mid-February-March 2010

19 Next Steps (cont.) Continue Harmonization – Study Design – Subject Data – CTR&R – ICSR – SDTM V – CT Lab – NCI Projects (C3PR 2.0, PSC 2.0, etc)

20 Next Steps (cont.) Other Tasks – Ontology (OWL) – Vocabulary – Scalability

21 HL7 Harmonization Proposals RIM C30-01 Make ContextStructure.versionNumber ST RIM C30-02 Add Role and Participation.priorityNumber oRIM C30-06 Change definition for Person.raceCode and ethnicGroupCode

22 HL7 Harmonization Proposals (cont.) Vocab C30-03 Add additional temporal relationships Vocab C30-04 Add Contact roleLinkType Vocab C30-05 Add Baseline ActRelationship Vocab C30-07 Add Oversees roleLinkType Vocab C30-08 Add Prediction classCode Vocab C30-09 Add Uses ActRelationshipType

23 Intended Use of RIM-Based Model The RIM-based BRIDG model is NOT intended to replace all the RCRIM message models It is intended to help those familiar with HL7 representation to understand the semantics of the UML-based BRIDG model. It will act as a starting point for discussion on incorporating BRIDG requirements into existing HL7 models and vice versa where not already supported.

24 RCRIM DMIM Can the BRIDG RIM-based model be used as a DMIM? If so… – Existing structure will need to be reformatted – All existing RCRIM message models will need to be harmonized with BRIDG

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

26 Q & A