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

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. 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. 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. CDISC ADaM Validation Checks V1.2
Can you check for just oneADSL?
4© CDISC 2014

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. 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. 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. 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. 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. 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. 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. 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