CDISC and how Stata can helpus 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-profitorganization that has established standards to supportthe acquisition, exchange, submission and archive ofclinical research data and metadata. The CDISCmission is to develop and support global, platform-independent data standards that enable informationsystem interoperability to improve medical research andrelated areas of healthcare. CDISC standards arevendor-neutral, platform-independent and freelyavailable via the CDISC website.
Source: www.cdisc.org
Overview of CDISC standards
Protocol
CRF
Operationaldatabase
Results
Analysisdatasets
Tabulationdatasets
PRM
CDASH
ODM
SDTM
ADaM
Overview of CDISC standards
Protocol
CRF
Operationaldatabase
Results
Analysisdatasets
Tabulationdatasets
PRM
CDASH
ODM
SDTM
ADaM
Terminology
ODM
The Operational Data Model (ODM) is a vendorneutral, platform independent format forinterchange and archive of data collected inclinical trials. The model represents studymetadata, data and administrative dataassociated 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 trialdata
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
STUDYIDDOMAINUSUBJIDSUBJIDRFSTDTCRFENDTCAGESEXRACE
xxxDMxxx-1011012009-02-052009-03-2542FCaucasian
xxxDMxxx-1021022009-02-052009-03-2524MCaucasian
xxxDMxxx-1031032009-02-042009-03-1033FCaucasian
xxxDMxxx-1041042009-02-042009-03-2529FCaucasian
xxxDMxxx-1051052009-02-042009-03-2528MCaucasian
Another SDTM example
VSTESTCDVSTESTVSCATVSPOSVSORRESVSORRESUVSSTRESCVSSTRESN
BMIBMIHeight and weight23.2kg/m^223.223.2
HEIGHTHeightHeight and weight162cm162162
WEIGHTWeightHeight and weight61kg6161
DIABPDBPBP and heart rateSTANDING77mm Hg7777
HRHeart RateBP and heart rateSTANDING.bpm.
SYSBPSBPBP and heart rateSTANDING116mm Hg116116
DIABPDBPBP and heart rateSUPINE61mm Hg6161
HRHeart RateBP and heart rateSUPINE56bpm5656
SYSBPSBPBP and heart rateSUPINE111mm Hg111111
ADaM
Analysis dataset model
Designed for analysis of data
Many variables are copied from SDTM, others arederived
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 dbexport (ODM)
Pseudo-SDTM
SDTM
Results
Analysisdatasets
Questions
