Transcript HCLS$$ClinicalObservationsInteroperability$KerstinBo

Knowledge
Base
SDTM
Disease Registry
Entry Form
and other
Auhortities
Clinical Trial
Sponsor
Case Report Form
Outbreak Report
Adverse Event
Data
EHR
Safety Org.
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)
Secondary Use
in Health Care
as Knowledge Base
Subject
SDTM
Auhortities
Patient
Secondary Use
Epi / Population /
Real life analysis
Secondary Use
in Drug Development
as Knowledge Base
Organizing
clinical trials
information that
is to be submitted
to the FDA.
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
Medical History (events domain)
Using MedDRA
Vital Signs and Subject
Characteristics (findings domain)
Using Controlled Terminologies
of Test Codes
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
Relationship HL7/CDISC
SDTM variables specified
as packages of Controlled
Terminologies
Published as an Excel matrixes
on CDISC website
In OWL format
CDISC
Clinical Data
Interchange Standards
Consortium
RCRIM
Regulated Clinical Research
and
Information Management,
technical committee
HL7
“Health Level
Seven”
NCI Thesaurus
UMLS
BRIDG
Biomedical Research
Integrated Domain
Group Model
CDISC SDTM’s Domains
Interventions
Events
Findings
Other
Exposure
AE
Labs
Incl Excl*
Demog
ConMeds
Disposition
Vitals
Subj Char*
RELATES*
SUPPQUAL*
Subst Use*
MedHist
PhysExam
ECG
QS*, MB*
CP*, DV*
From CDISC SDTM Overview & Impact to AZ, 2004, by Dan Godoy, presented
at the first CDISC/SDM meeting 20 October 2004
Comments*
Study Design*
Study Sum*
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
Grouping Synonym
Qual
Qual
Res
Res
Qual
Generic dataset structure for all domains
Based on the descriptions in the Study Data Tabulation Model document
Var
Var
Qual
Record
Qual