1. Presentation to RCRIM San Antonio, TX January 15, 2008 Meredith Nahm, M.S. CV/TB Global Data Standards Efforts Therapeutic Area Data Standards: Cardiovascular &Tuberculosis Clinical Content Standards Supported by BAA-RM-04-23

2. Purpose: Patient Clinician Healthcare Data Systems Patient care Quality Improvement Research Reimbursement Post Marketing Safety Decision Support Administration & Mgt. Public Health Reporting … Data Uses Single Source Multiple Uses

3. Goals Focus on methodology for developing therapeutic area data standards Produce useful products for CV/TB Report experience, process, best practices

4. Project GoalStatus Create stakeholder groupComplete Create master data element list from healthcare and related secondary uses Complete Define a set of data elements according to the ISO 11179 standard (CV 21-TB 90 data elements) Complete Develop consensus clinical definitions for the data elementsComplete Create a dynamic model of the domain represented through an activity diagram, using the UML standard Complete Create a research representation of the data elements in the CDISC SDTM model. *CV will create representation in the future Complete* Make the resulting standards available to the public through an ANSI accredited balloting process In progress, 2008

5. Methods Standardize at source healthcare –Data element as unit of exchange –Specificity sufficient for semantic interoperability –Work within HL7 Include all Stakeholders –Research representation CDISC –Public Health Representation CDC –Quality Imp. Professional Societies

6. Results Section 1: Use cases and storyboards (H) Section 2: Data elements and clinical definitions (U) Section 3: Domain Class model (H) Section 4: Domain Activity diagram (H) Section 5: Data collection forms (R) Section 6: Suggestions for SDTM representation (R) H = Healthcare / R = Research / U = Universal

7. TB Class Model

9. TB Activity Model

11. Proposal for Clinical Content Work Clinical Context Experts:Clinicians / Clinical Professional Societies HL7 Clinical Interoperability Council (CIC) as forum Define Data Elements for clinical areas Construct DAMs CIC as forum for mentoring, knowledge sharing and maintaining consistency DAMs available to TCs and SIGs for work product / template specification Identify methods for including RCRIM knowledge

12. Next Steps: Public Review Release - Research HL7 Review – Healthcare Industry & Focus Group Webinars

13. Discussion Materials should be available for HL7 public Review Ballot Process

14. Questions ? Thank you !