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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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, NCShelley.Dunn@d-wise.com+1 919-334-6089www.d-wise.com

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Ed Lombardi

Carlsbad, CAelombardi@agility-clinical.com

www.agility-clinical.com