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The Best Practices of CDISC ADaM Validation Checks: Past, Present, and Future


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The Best Practices of CDISC ADaM Validation Checks: Past, Present, and Future

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The Best Practices of CDISC ADaM Validation Checks: Past, Present, and Future

  1. 1. The Best Practices of CDISC ADaM Validation Checks: Past, Present, and Future Prepared by Shelley Dunn and Ed Lombardi CDISC ADaM Compliance Team Co-Leads Presented by Shelley Dunn d-Wise
  2. 2. © CDISC 2014 Objectives • Provide an overview of past, present, and future ADaM validation checks • Understand scope and best practices of implementing ADaM validation checks • Identify machine-testable criteria in ADaM documents • Illustrate current challenges writing validation checks • Discuss best practices for ADaM validation in general 2
  3. 3. © CDISC 2014 Past: ADaM Validation Checks 3 ADaM IG V1.0 ADaM Compliance Sub-Team ADaM Validation Checks V1.2 (July 2012) Validation Tools (Programmed) • ADaM documents  ADaM IG  ADaM Validation Checks • ADaM validation checks document (specifications) vs. programmed checks • Compliance tools  Programmed checks  Validation software
  4. 4. © CDISC 2014 CDISC ADaM Validation Checks V1.2 4 Can you check for just one ADSL?
  5. 5. © CDISC 2014 Scope and Specifications Scope of ADaM Checks • Validation checks are a specifications document • Checks are based on machine- testable criteria • Requires programming • Does not include non-machine testable criteria • Does not include sponsor- defined checks Know the Tools • Many companies rely on an outside vendor to validate ADaM data sets • Does the tool check all machine-testable criteria? Are they implemented correctly? • ADaM validation is more than just running a tool and hoping for no errors 5
  6. 6. © CDISC 2014 Present: ADaM Validation Checks 6 Updates to ADaM Validation Checks V1.2 BDS-TTE (Time-to-Event) ADAE (Adverse Events) DRAFT Review Target Q4 2014 • More ADaM documents published • New structures  new concepts  new checks • Consistency with current checks • DRAFT out for review
  7. 7. © CDISC 2014 Vague Language & Machine-Testable • Be aware of “vague” language • May need to re-word to ensure “machine-testable” Example text from TTE: “It is generally recommended that time-to-event data be stored separately from non-time-to-event data even if they both fit within the ADaM BDS.” Example text from ADAE: “There is no need for AVAL or AVALC.” 7
  8. 8. © CDISC 2014 Challenges 8 BDS Time-to-Event • How do you know if a data set is a TTE data set? • CNSR (Censor) is “Cond” for BDS & “Req” for TTE • Implement TTE checks when TTE is part of another BDS data set • What is the CLASS for TTE? BDS? BDS-TTE? • Naming convention – may not be named ADAE • ADAE vs. OCCDS ADAE
  9. 9. © CDISC 2014 Future: ADaM Validation Checks 9 Updated ADaM IG v1.1 Occurrence Data Structure (OCCDS) Data Structure for Integration Additional ADaM Documents • Closely tied to latest ADaM documents • Educate users about tools • Supplement ADaM validation checks with sponsor-defined checks • Therapeutic Area (TA) specific checks
  10. 10. © CDISC 2014 Compliance Outside of ADaM Validation Checks Sponsor-Defined Checks • Check sponsor-defined controlled terminology (CT)/ value-level metadata (VLM) • Other sponsor standards  Data set  Variable  Metadata • Custom variable compliance Manual Checks • Ensure rules are followed • Data sets contains variables needed for analysis • Proper/adequate traceability 10 SDTM ADaM TLFs
  11. 11. © CDISC 2014 Best Practices • For all users of ADaM Validation Checks:  Understand the tools  Implement sponsor-defined checks for ensuring compliance to company standards  Add sponsor-defined checks for CT and VLM • For CDISC Authors:  Consider “CLASS” and/or how to identify data structures  Reduce vague language  Consider machine-testable criteria when preparing new CDISC standards 11
  12. 12. © CDISC 2014 Questions? Contact Information ADaM Compliance Sub-Team Co-Leads Shelley Dunn Morrisville, NC +1 919-334-6089 12 Ed Lombardi Carlsbad, CA