Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

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

1,033 views

Published on

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

Published in: Healthcare
  • Be the first to comment

  • Be the first to like this

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 Shelley.Dunn@d-wise.com +1 919-334-6089 www.d-wise.com 12 Ed Lombardi Carlsbad, CA elombardi@agility-clinical.com www.agility-clinical.com

×