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The Best Practices of CDISC ADaM Validation
Checks: Past, Present, and Future
Prepared by Shelley Dunn and Ed Lombardi
CDI...
Objectives
• Provide an overview of past, present, and future ADaM
validation checks
• Understand scope and best practices...
Past: ADaM Validation Checks
ADaM IG V1.0
ADaM Compliance
Sub-Team
ADaM Validation Checks
V1.2 (July 2012)
Validation Tool...
CDISC ADaM Validation Checks V1.2
Can you check for just oneADSL?
4© CDISC 2014
Scope and Specifications
Scope of ADaM Checks
• Validation checks are a
specifications document
• Checks are based on mach...
Present: ADaM Validation Checks
Updates to ADaM
Validation Checks V1.2
BDS-TTE (Time-to-Event)
ADAE (Adverse Events)
DRAFT...
Vague Language & Machine-Testable
• Be aware of “vague” language
• May need to re-word to ensure “machine-testable”
Exampl...
Challenges
BDS Time-to-Event
• How do you know if a data set
is a TTE data set?
• CNSR (Censor) is “Cond” for
BDS & “Req” ...
Future: ADaM Validation Checks
Updated ADaM IG v1.1
Occurrence Data
Structure (OCCDS)
Data Structure for
Integration
Addit...
Compliance Outside of ADaM
Validation Checks
Sponsor-Defined Checks
• Check sponsor-defined
controlled terminology (CT)/
v...
Best Practices
• For all users of ADaM Validation Checks:
 Understand the tools
 Implement sponsor-defined checks for en...
Questions?
Morrisville, NC
Shelley.Dunn@d-wise.com
+1 919-334-6089
www.d-wise.com
Contact Information
ADaM Compliance Sub-...
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CDISC International Interchange 2014

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The Best Practices of CDISC ADA-M validation checks past present and future

Published in: Healthcare

CDISC International Interchange 2014

  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. 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© CDISC 2014
  3. 3. Past: ADaM Validation Checks 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 3© CDISC 2014
  4. 4. CDISC ADaM Validation Checks V1.2 Can you check for just oneADSL? 4© CDISC 2014
  5. 5. 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© CDISC 2014
  6. 6. Present: ADaM Validation Checks 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 6© CDISC 2014
  7. 7. 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© CDISC 2014
  8. 8. Challenges 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 8© CDISC 2014
  9. 9. Future: ADaM Validation Checks 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 9© CDISC 2014
  10. 10. 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 SDTM ADaM TLFs 10© CDISC 2014
  11. 11. 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© CDISC 2014
  12. 12. Questions? Morrisville, NC Shelley.Dunn@d-wise.com +1 919-334-6089 www.d-wise.com Contact Information ADaM Compliance Sub-Team Co-Leads Shelley Dunn Ed Lombardi Carlsbad, CA elombardi@agility-clinical.com www.agility-clinical.com 12© CDISC 2014

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