CDISC and how Stata can help us implement it

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 vendorneutral, platform-independent and freely available via the CDISC website. Source: www.cdisc.org

Overview of CDISC standards

Protocol PRM CRF CDASH Analysis datasets ADaM Operational database ODM Tabulation datasets SDTM

Results

Overview of CDISC standards

Protocol PRM

Results

y g lo o in rm e T
CRF CDASH Analysis datasets ADaM

Operational database ODM Tabulation datasets 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 xxx xxx xxx xxx xxx DOMAIN DM DM DM DM DM USUBJID xxx-101 xxx-102 xxx-103 xxx-104 xxx-105 SUBJID 101 102 103 104 105 RFSTDTC RFENDTC AGE SEX F M F F M RACE Caucasian Caucasian Caucasian Caucasian Caucasian 2009-02-05 2009-03-25 42 2009-02-05 2009-03-25 24 2009-02-04 2009-03-10 33 2009-02-04 2009-03-25 29 2009-02-04 2009-03-25 28

Another SDTM example

VSTESTCD VSTEST BMI HEIGHT WEIGHT DIABP HR SYSBP DIABP HR SYSBP BMI Height Weight DBP Heart Rate SBP DBP Heart Rate SBP VSCAT Height and weight Height and weight Height and weight BP and heart rate BP and heart rate BP and heart rate BP and heart rate BP and heart rate BP and heart rate VSPOS VSORRES 23.2 162 61 STANDING 77 STANDING . STANDING 116 SUPINE SUPINE SUPINE 61 56 111 VSORRESU VSSTRESC VSSTRESN kg/m^2 cm kg mm Hg bpm mm Hg mm Hg bpm mm Hg 23.2 162 61 77 . 116 61 56 111 116 61 56 111 23.2 162 61 77

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