cdisc and how stata can help us implement it dr adam jacobs dianthus medical limited
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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, platform-
independent 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 CRFOperational database
ResultsAnalysis datasets
Tabulation datasets
PRM CDASH ODM
SDTMADaM
Overview of CDISC standards
Protocol CRFOperational database
ResultsAnalysis datasets
Tabulation datasets
PRM CDASH ODM
SDTMADaM
Terminology
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 RFENDTC AGE SEX RACE
xxx DM xxx-101 101 2009-02-05 2009-03-25 42 F Caucasian
xxx DM xxx-102 102 2009-02-05 2009-03-25 24 M Caucasian
xxx DM xxx-103 103 2009-02-04 2009-03-10 33 F Caucasian
xxx DM xxx-104 104 2009-02-04 2009-03-25 29 F Caucasian
xxx DM xxx-105 105 2009-02-04 2009-03-25 28 M Caucasian
Another SDTM example
VSTESTCD VSTEST VSCAT VSPOS VSORRES VSORRESU VSSTRESC VSSTRESN
BMI BMI Height and weight 23.2 kg/m^2 23.2 23.2
HEIGHT 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)
Pseudo-SDTM
SDTM
ResultsAnalysis datasets
Questions