1CDISC 2002 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

2CDISC 2002 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.

3CDISC 2002 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 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.

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

Patient Profile Spec vs. SDS 2.0: Key Differences 1. Removes common selection variables a. Can be joined into views by data warehouse 2. Uses more normalized Demographics a. Standardizes fixed set of core required variables b. Can represent any additional characteristics in separate Subject Characteristics table 3. Introduces new Study Summary table a. Will simplify document creation and record key attributes of studies (not required for pilot) 4. Classification of variable roles: Subject identifiers, Topic, timing, qualifiers 5. Introduces concepts of controlled terminology and standardized content requirements

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

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

8CDISC 2002 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

9CDISC 2002 Standards and the Change Process Industry FDA CDISC Standards

10CDISC 2002 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?

11CDISC 2002 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