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Dianne Weatherall: 2013-04-11

An exploration of quality gaps in SDTM implementation activities and ideas on how to address these gaps through appropriate resourcing. Dianne Weatherall: 2013-04-11. GOAL. Adoption of CDISC standards has led to: new processes ( aCRF , metadata, programming) new responsibilities

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Dianne Weatherall: 2013-04-11

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  1. An exploration of quality gaps in SDTM implementation activities and ideas on how to address these gaps through appropriate resourcing Dianne Weatherall: 2013-04-11

  2. GOAL • Adoption of CDISC standards has led to: • new processes (aCRF, metadata, programming) • new responsibilities • Goal: to discuss the “best” SDTM team to implement the new process

  3. DEFINE THE PROBLEM Define what is wrong with the current setup

  4. ROOT CAUSE OF QUALITY ISSUES Poll on the SDTM LinkedIn group:What is the primary cause of quality issues in SDTM?

  5. ROOT CAUSE OF QUALITY ISSUES Lack of understanding of SDTM – WHY?

  6. ROOT CAUSE OF QUALITY ISSUES Lack of understanding of clinical data – WHY?

  7. ROOT CAUSE OF QUALITY ISSUES Non-standard data – WHY?

  8. SUMMARY OF ROOT CAUSES Company silo’s  Lack of data skills of Biostats teams  Lack of CDASH / SDTM skills of Data teams  Time and effort to build expertise  Customer-specific  Poor study planning  Expensive  - join a user group!

  9. CRITERIA FOR THE BEST SDTM TEAM Corporate structure Team scenarios

  10. CORPORATE STRUCTURE *** Blur the line between DM and BIOS

  11. BEST TEAM SCENARIO

  12. ROLES AND SKILLS Data Management ----------------------------------------Biostatistics

  13. TEAM SCENARIO 1

  14. TEAM SCENARIO 2

  15. TEAM SCENARIO 3

  16. TEAM SCENARIO 4

  17. Other things to consider • Submissions • Continuity across studies • Consistency across studies • Change control • Bottle necks (reviewer team) • ADaM / statistical output resourcing

  18. RESOURCE CRITERIA

  19. THE BEST SDTM TEAM *** Understand the data *** Understand the purpose

  20. ????????????????????????????????????? QUESTIONS

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