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The Evolution of SDTM

The Evolution of SDTM. What’s new?. Peter Van Reusel Business Unit Director Projects Business & Decision Life Sciences Tel +32 2 774 11 00 Fax +32 2 774 11 99 Mobile +32 476 545 917 peter.van.reusel@businessdecision.com Sint-Lambertusstraat 141 Rue Saint-Lambert 1200 Brussels

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The Evolution of SDTM

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  1. The Evolution of SDTM What’s new? Peter Van Reusel Business Unit Director Projects Business & Decision Life Sciences Tel +32 2 774 11 00 Fax +32 2 774 11 99 Mobile +32 476 545 917 peter.van.reusel@businessdecision.com Sint-Lambertusstraat141 Rue Saint-Lambert 1200 Brussels www.businessdecision-lifesciences.com

  2. Agenda 1 2 3 Overview SDTM 3.1.3 What’s next?

  3. Agenda 1 2 3 Overview SDTM 3.1.3 What’s next?

  4. Overview of CDISC Models DEC 2012 Content Standards Semantics Upcoming Technical Standards Therapeutic Areas

  5. Updates over time DEC 2012 Define.xml v2.0 SHARE PKD Healthcare Link 2009 2012 2006 2007 2002 2008 2005 2003 2004 2010 2011 CDASH v1.2 Virology SDTM IG v3.1.5 Parkinson’s Disease SDTM IG v3.1.4 Devices CV Imaging BRIDG v3.0.3 BRIDG v3.2 SDTM v3.1.2 Am.1 Schizo- phrenia ADaM Val. Checks v1.0 ADaM Val. Checks v1.2 SDTM v1.2 SDTM IG v3.1.2 SEND v3.1 Alzheimer v1.0 SDTM v1.3 SDTM IG v3.1.3 SDTM.xml v1.0 BRIDG v3.0.2 SDM.XML v1.0 CDASH v1.0 Imaging SDTM v1.1 SDTM IG v3.1.1 ADaM v2.1 ADaM IG v1.0 Tuberculosis Cardio- vascular ODM v1.3.1 ADaM Val. Checks v1.1 BRIDG v2.1 Pain Alzheimer v1.1 SDTM v1.0 SDTM IG v3.1 PRM Toolset v1.0 BRIDG v3.0.1 ODM v1.3 BRIDG v1.1 Define.xml v1.0 BRIDG v3.0 BRIDG v2.0 ADaM IG v1.1 CDASH v1.1 CDASH UG v1.0 Protocol Model v1.0 2013 Standard Protocol Toolset ODM v1.2 ODM v1.2.1 ADaM v2.0 BRIDG v1.0 BRIDG v1.1.1 BRIDG v2.2 ODM v1.1 BRIDG v3.1 SEND v3.0 … Content Standards Semantics Technical Standards Therapeutic Areas /

  6. Technical Plan Project Schedule http://www.cdisc.org/stuff/contentmgr/files/0/5fbd2b7afd4cc3ae3274d97d44d7a8b0/misc/cdisc1012_2.pdf

  7. Data Standards Governance DATA GOVERNANCE PROCESS DEDICATED TEAM

  8. Agenda 1 2 3 Overview SDTM 3.1.3 What’s next?

  9. IG Format SDTMIG V3.1.3 is presented as an annotated version of SDTMIG V3.1.2. Sticky Notes Used to indicate what has changed or what has been inserted

  10. IG Format Document Attachment Annotations Document attachments are “pinned” Whole Section replacement Sections blanked out due to comprehensive update

  11. What’s new in 3.1.3? SDTM V1.3 and SDTM IG V3.1.3: New variables in general observation classes SDTMIG V 3.1.2 Amendment 1 content added to IG Inclusion of Oncology Therapeutic Area domains Changes to the Trial Design section Document formatting updates

  12. Oncology Domains The tumor package consists of three SDTM Findings Domains: TU : Tumor Identification TR : Tumor Results RS : Disease Response Typically combined during analysis

  13. Oncology Domains

  14. Tumor Identification (TU) Represents data that uniquely identifies tumors • Unique Tumor ID: • Internal or external Identifier (e.g. Medical Image ID number) • Sponsor-defined Identifier • Identifier to link to TR domain • Identification of: • Target • Non-Target • New tumors • (e.g. RECIST) • Anatomical Location • + • Additional location variables • Laterality (LEFT, RIGHT, BILATERAL) • Directionality (UPPER, INTERIOR) • Portion or Totality (ENTIRE, SINGLE, SEGMENT) Assessor role Method

  15. Tumor Results (TR) Represents quantitative measurements and/or qualitative assessments Unique Tumor ID Test and result (Controlled Terminology) New convention Method Assessor role

  16. Disease Response (RS) Represents the response evaluation(s) RSCAT is used to identify the criteria used in the assessment of response Unique Tumor ID Test and result (Controlled Terminology) Assessor Role

  17. RELREC Linking TU, TR and RS --LNKID: one record in TU to many records in TR --LNKGRP: one record in TR to many records in RS

  18. Trial Summary Code of the term in TSVAL Name + version number of the Reference Terminology from which TSVALCD is taken • No information • Invalid • Other • Positive infinity • Negative infinity • Unencoded • Derived • Unknown • Asked but unknown • Temporarily unavailable • Not asked • Quantity sufficient • Trace • Masked • Not applicable Null flavor for the value of TSPARM: to be populated if TSVAL is null

  19. Agenda 1 2 3 Overview SDTM 3.1.3 What’s next?

  20. General Releases DEC 2012 Draft (for Review) SDTM IG v3.1.4 Batch 1 SDTM IG v3.1.4 Batch 2 (coming soon) Define.xml v2.0 Upcoming ADaM IG v1.1 CDASH v1.2 Standard Protocol Concepts + IG SDTM.xml v1.0 SEND v3.1 BRIDG 4.0 SDTMIG 3.1.5 SDTM 1.5

  21. Exposure Domains Supplement New domain : Exposure as Collected (EC) Clarifications of: EX domain definition EXDOSU EXDOSE EXVAMT Standard representation of: collected doses not taken collected reason why a dose was not taken collected intended dose details concentration / dosage strength masked records Variables proposed for deprecation: EXDOSTOT, EXVAMT and EXVAMTU SDTM IG V3.1.4 Batch 1

  22. SDTM IG V3.1.4 Batch 1 • Immunogenicity Domains Supplement • Immunogenicity Assessments (IS) • Assessments determining whether a therapy provoked/caused/induced an immune response • Skin Response (SR) • Dermal responses to antigens • Findings About an Intervention • Different domain code instead of FA

  23. SDTM IG V3.1.4 Batch 1 • Reproductive Details Domain • Captures all Reproduction details related to the subject in a FINDINGS domain • E.g.: • Subject’s reproductive ability • History: number of previous pregnancies & number of births

  24. Therapeutic Areas DEC 2012 PKD Dec 2012 Imaging (CT Modality) Mar 2013 CardioVascular Apr 2013 Alzheimer’s Disease User Guide V1.1 May 2013 Schizophrenia Aug 2013 CFAST Asthma Aug 2013 CV Imaging Sep 2013 CFAST Diabetes Dec 2013

  25. Questions ?

  26. Thank you for your attention Peter Van Reusel Business Unit Director Projects Business & Decision Life Sciences Tel +32 2 774 11 00 Fax +32 2 774 11 99 Mobile +32 476 545 917 peter.van.reusel@businessdecision.com Sint-Lambertusstraat141 Rue Saint-Lambert 1200 Brussels www.businessdecision-lifesciences.com

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