RCRIM – Standard Domains Agenda

1. RCRIM – Standard Domains Agenda • NCI Presentation • Standard Domains Working Group Goals • Introduction to FDA Information Model (FIM) • Discussion: Moving forward on HL7 CR Standard Domains • CDISC, FIM or both CDISC 2002

2. Standard Domains for Clinical Research Data - Goals • To identify alternatives for incorporating CDISC data models that represent typical safety and efficacy data domains used in clinical research into HL7 as accredited standards, implementation guides, documents, etc. and to expand these models with standardized codes and controlled terminology • To develop standard messages for transmitting clinical research data (such as lab data) • Overlaps with CDISC ODM, LAB and SDS teams. CDISC 2002

3. Standard Domains for CR Data – Discussion Points • Identifying ways to get CDISC submission domain models published as an HL7 document or standard • Exploring opportunities to utilize HL7 work in vocabularies and codes to improve the SDS models • Consider applying the ISO 11187 standard for metadata to the models • Promote interaction with multiple groups: (CDISC, NCI, FDA, CDC-NACCR, Professional Societies) • Continue current activities to explore an HL7 implementation of the LAB model and an HL7 rendition of the ODM. CDISC 2002

4. Demographics Disposition Exposure Labs (Chemistry, Hematology, Urinalysis) Physical Exam Medical History Concomitant Medications Adverse Events Vitals (Horizontal) Vitals (Vertical) ECG (Horizontal) ECG (Vertical) SDS V. 2.0 Domain Models

5. Patient Profile Spec vs. SDS 2.0: Key Differences • Removes common selection variables • Can be joined into views by data warehouse • Uses more normalized Demographics • Standardizes fixed set of core required variables • Can represent any additional characteristics in separate Subject Characteristics table • Introduces new Study Summary table • Will simplify document creation and record key attributes of studies (not required for pilot) • Classification of variable roles: Subject identifiers, Topic, timing, qualifiers • Introduces concepts of controlled terminology and standardized content requirements

6. Patient Profile Structures Subject Events Observations Assessments Attributes/Trtment Studies Labs Exposure Adverse Events Vital Signs Demo- graphics Subject Characteristics Findings ECG Con Meds Disposition Physical Exam Medical History

7. FDA Information Model Structures Interventions Events Findings Labs Studies Adverse Events Exposure Vital Signs Con Meds Demo- graphics Subject Charstics Medical History ECG Disposition Physical Exam

8. Differences between SDS and FIM • Merges 12 different domains into 3 types (+ Demographics) • Drops 2 character domain prefix; adds as variables • Patient population flags • Precision variable • Variable name changes due to generalization CDISC 2002

9. Standards and the ChangeProcess FDA Industry CDISC Standards CDISC 2002

10. Issues • FIM acceptance by Statisticians • FIM Compatibility with current DM/Stats processes and sponsor standards to produce CRTs and Analysis Files • Impact on CDISC SDS team and implementers • Where to draw the line between current models and FIM? • Comprehensiveness – SDS modeled only most common 80/20 data variables per domain – will that suffice for all data? • What about other unique variables? Analysis variables? • Other domains? • Timeframe/transition – SAS datasets require tools to be in place to be useful (for viewing, merging, etc.) • Would FDA accept CDISC SDS or FIM format in interim? CDISC 2002

11. Options for Moving Forward • Freeze CDISC SDS at V 2.0; cease model development until FDA publishes guidance • SDS can continue with implementation guidance • Publish V 2.1 as CDISC Doc only • FDA Publishes FIM • FDA accepts V 2.1 as well as FIM format files? • Publish V 2.1 as CDISC/HL7 Doc • Publish V 3.0 based on FIM as HL7 Metadata Document • RCRIM Publishes FIM CDISC 2002