Secondary Uses Primary Use EHR and other Auhortities Clinical Trial Knowledge Base Disease Registry SDTM and other Auhortities Clinical Trial Sponsor Entry Form Case Report Form Outbreak Report Safety Org. Adverse Event Data Secondary Uses Primary Use EHR From Landen Bain’s presentation at the Clinical Observations Interoperability Telcon, 28 August 2007, with some minor additions relevant for Drug Development

Primary Use in Health Care per patient Primary use in Drug Development (i.e. Secondary Use of Health Care data in clinical research) Primary Use in Health Care per patient Secondary Use in Health Care as Knowledge Base Subject SDTM Auhortities Organizing clinical trials information that is to be submitted to the FDA. Patient Secondary Use Epi / Population / Real life analysis Secondary Use in Drug Development as Knowledge Base

Trial Inclusion/Exclusion Criteria domain TRIAL DESIGN MODEL Trial Summary Parameter domain e.g AGESPAN and SEXPOP Trial Inclusion/Exclusion Criteria domain SDTM Auhortities Inclusion/Exclusion Criterion Not Met (findings domain) Refeering back to IETESTCD CLINICAL OBSERVATIONS per SUBJECT such as Demographics (special purpose domain) with fixed variables such as SEX, BRTHDTC, AGE / AGEU Vital Signs and Subject Characteristics (findings domain) Using Controlled Terminologies of Test Codes Medical History (events domain) Using MedDRA Concomitant Medications and Substance Use (interventions domain)

Backup slides Background to SDTM

CDISC SDTM and related initativies All terms and concepts are incorporated from NCI Thesaurus thorugh NCI EVS SDTM variables specified as packages of Controlled Terminologies Published as an Excel matrixes on CDISC website In OWL format NCI Thesaurus CDISC Clinical Data Interchange Standards Consortium UMLS RCRIM Regulated Clinical Research and Information Management, technical committee Relationship HL7/CDISC BRIDG Biomedical Research Integrated Domain Group Model HL7 “Health Level Seven”

CDISC SDTM’s Domains Interventions Events Findings Other Exposure AE Labs Incl Excl* Demog ConMeds Disposition Vitals Subj Char* RELATES* Subject Attributions Tables A place holder for additional subject data that does not “fit” within the other models ATSUBJ – designed to support subject level linking ATRECORD – designed to support record level linking (e.g. subject visit level, subject datetime event level, etc.) Submission Summary Information Model Model that contains information regarding the study type, title, phase, design, number of subjects, etc. RELATES A model that links/associates multiple observations within &/or across domains. EPOCH A model that contains the planned study interval of time points (e.g. “periods”, “cycles”, & “phase”) SUPPQUAL* Subst Use* MedHist PhysExam ECG Comments* Study Design* QS*, MB* CP*, DV* Study Sum* From CDISC SDTM Overview & Impact to AZ, 2004, by Dan Godoy, presented at the first CDISC/SDM meeting 20 October 2004

Basic Concepts in CDISC SDTM Observations and Variables The SDTM provides a general framework for describing the organization of information collected during human and animal studies. The model is built around the concept of observations, which consist of discrete pieces of information collected during a study. Observations normally correspond to rows in a dataset. Each observation can be described by a series of named variables. Each variable, which normally corresponds to a column in a dataset, can be classified according to its Role. Observations are reported in a series of domains, usually corresponding to data that were collected together. A domain is defined as a collection of observations with a topic-specific commonality about a subject. From the Study Data Tabulation Model document

Basic Concepts in CDISC SDTM Variable Roles Topic variables Identifier variables Timing variables Rule variables Qualifier variables Grouping Qualifiers Result Qualifiers Synonym Qualifiers Record Qualifiers Variable Qualifiers An example of a SDTM dataset (Vital Sign domain) Observation Record Topic Identifier Timing Record Qual Grouping Qual Synonym Qual Res Res Qual Var Var Qual Generic dataset structure for all domains Based on the descriptions in the Study Data Tabulation Model document