Secondary Uses

1
Knowledge Base
SDTM
and other Auhortities
Clinical Trial Sponsor
Case Report Form
Entry Form
Outbreak Report
Safety Org.
Adverse Event Data
Secondary Uses
Primary Use
From Landen Bains presentation at the Clinical
Observations Interoperability Telcon, 28 August
2007, with some minor additions relevant for Drug
Development
2
Primary use inDrug Development (i.e. Secondary
Use of Health Care data in clinical research)
Primary Usein Health Careper patient
Secondary Usein Health Careas Knowledge Base
Subject
SDTM
Auhortities
Organizing clinical trials information that is to
be submitted to the FDA.
Patient
Secondary Usein Drug Developmentas Knowledge
Base
Secondary UseEpi / Population / Real life
analysis
3
TRIAL DESIGN MODEL
Trial Summary Parameter domaine.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 conceptsare incorporated from NCI
Thesaurus thorugh NCI EVS
SDTM variables specifiedas packages of
ControlledTerminologies Published as an Excel
matrixeson CDISC website
NCI Thesaurus
In OWL format
CDISCClinical Data Interchange Standards
Consortium
UMLS
RCRIM Regulated Clinical Research and
Information Management,technical committee
Relationship HL7/CDISC
BRIDGBiomedical Research Integrated Domain Group
Model
HL7 Health Level Seven
6
CDISC SDTMs Domains
Interventions
Events
Findings
Other
Exposure
AE
Labs
Demog
Incl Excl
ConMeds
Disposition
Vitals
Subj Char
RELATES
SUPPQUAL
MedHist
ECG
PhysExam
Subst Use
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 SDTMObservations 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 SDTMVariable 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


RecordQual
Topic
Identifier
Timing
GroupingQual
SynonymQual
Res
ResQual
Var
VarQual
Generic dataset structure for all domainsBased
on the descriptions in the Study Data Tabulation
Model document