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Overview of CDISC standards and use cases along the E2E data management process

Overview of CDISC standards and use cases along the E2E data management process. Dr. Philippe Verplancke ESUG Marlow, UK 27 May 2009. Study #2 – dmg.xpt. Study #1 – demog.xpt. REMINDER w hy we are doing this. Study #3 – axd222.xpt. Study #4 – dmgph.xpt. The speaker’s view on CDISC.

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Overview of CDISC standards and use cases along the E2E data management process

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  1. Overview of CDISC standards and use cases along the E2E data management process Dr. Philippe Verplancke ESUG Marlow, UK 27May 2009

  2. Study #2 – dmg.xpt Study #1 – demog.xpt REMINDER why we are doing this Study #3 – axd222.xpt Study #4 – dmgph.xpt

  3. The speaker’s view on CDISC Sh. Semantics Terminology How do we call things? • Structure • Where do we put things? • Protocol (PRG) • CRF pages (ODM, CDASH) • Lab forms (LAB) • Data tables (SDTM, define.xml) • Analysis tables (ADaM) • Format • How do computers store and exchange things? • XML (ODM) • ASCII • SAS 3

  4. CDISC Production Standards – Where are we now? *Specification in FDA Guidance

  5. E2E data management use cases CRF Design & Dataset Design Protocol Writing & Trial Design Sub- Mission & Review Data Analysis Data Collection Data Cleaning Archiving SDTM define.xml ADaM PRM incl. TDM ODM Metadata CDASH define.xml ODM Data & Audit Trail LAB ODM Data & Audit Trail SDTM ADaM ODM Data & Audit Trail Shared Metadata i.e. not just shared semantics but also syntax, format, datatypes, measurement units, etc. Shared Semantics i.e. not just Codelists („Terminology“) but also Valuelists, Relationships, Concepts, etc. 5

  6. Metadata sharing, e.g. between ODM and define.xml You can use identical pieces of XML (or SAS-based metadata) in different systems for different process steps! Protocol StudyEventDef ODM.xml = Representation of CRF pages (Visits, Forms, Items, etc.) FormDef ItemGroupDef ItemDef e.g., SYSBP CodeList define.xml = Representation of SDTM Domains, Variable and Value Level, i.e. Item level metadata MeasurementUnit Question text

  7. SDTM VALUE-LEVEL METADATA (2/2) But the devil is in the detail … <ItemDef OID="VS.SYSBP" Name="Systolic Blood Pressure“ / Name=“SYSBP” def:Label=“Systolic Blood Pressure" DataType=“integer" Length=“3" SASFieldName="SYSBP“ SDSVarName="SYSBP"> <Question> <TranslatedText xml:lang="en">Systolic Blood Pressure</TranslatedText> <TranslatedText xml:lang="de">Systolischer Blutdruck</TranslatedText> </Question> <MeasurementUnitRef MeasurementUnitOID=“MU.mmHg"/> </ItemDef> define.xml ODM.xml

  8. Use cases for data transfer: system view Protocol Tool Clinical Trial Registry ePRO Study Design Tool LAB Environment Subject Recruitment Tool(s) Other CDMS CRF Data Capture Protocol Document Other Analysis Tool(s) CDMS Trial Supply Management Tool CTMS Analysis Tool(s) Archive System or Warehouse Review Tool(s)

  9. Use cases for data transfer: ODM view auto-configure e-CRF auto-amend e-CRF auto-create a-CRF • Software tools are certified for each of these separate use cases. • These standard use cases allow for painless exchange between systems of different vendors!

  10. The E2E process can have many variations • Example 1: how to create CRF metadata (ODM) • copy from a metadata repository • import from another tool (e.g. a PRM/TDM tool) • create from scratch with a design tool • Example 2: how to move data from EDC/CDM database • into SDTM datasets in SAS • proprietary SDTM export mechanism in the EDC system • certified export to ODM, load ODM into SAS, transform to SDTM with SAS tools • certified export to ODM, transform to SDTM with • XML technology, load SDTM into SAS (PROC SQL)

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