Transcript CDISC - Stata

CDISC and how Stata can help
us implement it
Dr Adam Jacobs
Dianthus Medical Limited
CDISC
 What is CDISC?
 Overview of the standards
 Brief look at some data standards
 How can Stata help us work with the standards?
What is CDISC?
CDISC is a global, open, multidisciplinary, non-profit
organization that has established standards to support
the acquisition, exchange, submission and archive of
clinical research data and metadata. The CDISC
mission is to develop and support global, platformindependent data standards that enable information
system interoperability to improve medical research and
related areas of healthcare. CDISC standards are
vendor-neutral, platform-independent and freely
available via the CDISC website.
Source: www.cdisc.org
Overview of CDISC standards
Protocol
CRF
Operational
database
PRM
CDASH
ODM
Results
Analysis
datasets
Tabulation
datasets
ADaM
SDTM
Overview of CDISC standards
Protocol
CRF
Operational
database
PRM
CDASH
ODM
Results
Analysis
datasets
Tabulation
datasets
ADaM
SDTM
ODM
The Operational Data Model (ODM) is a vendor
neutral, platform independent format for
interchange and archive of data collected in
clinical trials. The model represents study
metadata, data and administrative data
associated with a clinical trial.
Source: www.cdisc.org
What can we do in ODM?
 Primarily for interchange and archiving of data
 Basic information about the study
 Can define CRF design (eCRF or paper)
 Both data and metadata
 Show clinical data:
– all data
– partial data
– changes to data
<SubjectData SubjectKey="SS_1002">
<StudyEventData StudyEventOID="SE_SCREENING_9605">
<FormData FormOID="F_HEMATOLO_1">
<ItemGroupData ItemGroupOID="IG_HEMATOLOGY"
ItemGroupRepeatKey="1">
<ItemData ItemOID="I_HEM_LBTEST" Value="WBC"/>
<ItemData ItemOID="I_HEM_LBORRES" Value="5.8"/>
</ItemGroupData>
</FormData>
</StudyEventData>
</SubjectData>
SDTM
 Study data tabulation model
 Specifies format of datasets for raw data
 Designed for storage of data
 Flexible model to accommodate many kinds of trial
data
 Some basic information on study design
SDTM domains
 SDTM data divided into domains (datasets)
 2 letter abbreviations, eg:
– DM: demographics
– VS: vital signs
– EX: exposure
– AE: adverse events
– TA: trial arms
SDTM domain classes
 6 classes of domains:
– Interventions (eg EX)
– Findings (eg AE)
– Observations (eg VS)
– Special purpose (DM and CO)
– Trial design (eg TA)
– Relationships (eg SUPPDM)
SDTM example
STUDYID
DOMAIN
USUBJID
SUBJID
RFSTDTC
xxx
DM
xxx-101
101
xxx
DM
xxx-102
xxx
DM
xxx
xxx
RFENDTC
AGE
SEX
RACE
2009-02-05 2009-03-25 42
F
Caucasian
102
2009-02-05 2009-03-25 24
M
Caucasian
xxx-103
103
2009-02-04 2009-03-10 33
F
Caucasian
DM
xxx-104
104
2009-02-04 2009-03-25 29
F
Caucasian
DM
xxx-105
105
2009-02-04 2009-03-25 28
M
Caucasian
Another SDTM example
VSTESTCD VSTEST
VSCAT
BMI
BMI
HEIGHT
VSPOS
VSORRES
VSORRESU VSSTRESC VSSTRESN
Height and weight
23.2
kg/m^2
23.2
23.2
Height
Height and weight
162
cm
162
162
WEIGHT
Weight
Height and weight
61
kg
61
61
DIABP
DBP
BP and heart rate
STANDING 77
mm Hg
77
77
HR
Heart Rate
BP and heart rate
STANDING .
bpm
.
SYSBP
SBP
BP and heart rate
STANDING 116
mm Hg
116
116
DIABP
DBP
BP and heart rate
SUPINE
61
mm Hg
61
61
HR
Heart Rate
BP and heart rate
SUPINE
56
bpm
56
56
SYSBP
SBP
BP and heart rate
SUPINE
111
mm Hg
111
111
ADaM
 Analysis dataset model
 Designed for analysis of data
 Many variables are copied from SDTM, others are
derived
 Should be just one step away from producing results
 Often many variables in the dataset
 Derived variables must be easily traceable
Workflow for clinical study
XML db
export (ODM)
PseudoSDTM
SDTM
Results
Analysis
datasets
Questions