The Best Practices of CDISC ADaM Validation Checks: Past, Present, and Future
Prepared by Shelley Dunn and Ed LombardiCDISC ADaM Compliance Team Co-Leads
Presented by Shelley Dunnd-Wise
© 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
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© CDISC 2014
Past: ADaM Validation Checks
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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
© CDISC 2014
CDISC ADaM Validation Checks V1.2
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Can you check for just one ADSL?
© 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
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© CDISC 2014
Present: ADaM Validation Checks
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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
© 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.”
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© CDISC 2014
Challenges
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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
© CDISC 2014
Future: ADaM Validation Checks
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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
© 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
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SDTM ADaM TLFs
© 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
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© CDISC 2014
Questions?
Contact InformationADaM Compliance Sub-Team Co-Leads
Shelley Dunn
Morrisville, [email protected]+1 919-334-6089www.d-wise.com
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Ed Lombardi
Carlsbad, [email protected]
www.agility-clinical.com