1. CDISC and how Stata can help us implement it
Dr Adam Jacobs
Dianthus Medical Limited

3. CDISC What is CDISC? Overview of the standards
Brief look at some data standards
How can Stata help us work with the standards?

4. 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:

5. Overview of CDISC standards
Protocol
CRF
Operational database
Results
Analysis datasets
Tabulation datasets
PRM
CDASH
ODM
ADaM
SDTM

6. Overview of CDISC standards
Protocol
CRF
Operational database
Results
Analysis datasets
Tabulation datasets
Terminology
PRM
CDASH
ODM
ADaM
SDTM

7. 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:

8. 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

9. <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>

10. 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

11. 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

12. 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)

13. SDTM example
STUDYID DOMAIN USUBJID SUBJID RFSTDTC RFENDTC AGE SEX RACE
xxx DM xxx F Caucasian
xxx DM xxx M Caucasian
xxx DM xxx F Caucasian
xxx DM xxx F Caucasian
xxx DM xxx M Caucasian

14. Another SDTM example
VSTESTCD VSTEST VSCAT VSPOS VSORRES VSORRESU VSSTRESC VSSTRESN
BMI BMI Height and weight kg/m^
HEIGHT Height Height and weight 162 cm
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
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

15. 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

16. Workflow for clinical study
XML db export (ODM)
Pseudo-SDTM
SDTM
Results
Analysis datasets

17. Questions