1. 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

2. 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

3. 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)

4. Backup slides
Background to SDTM

5. 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”

6. 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

7. 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

8. 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