SDTM Validation Rules

Sub-team

CDISC INTRAchange

Feb 26th, 2014

© CDISC 2014

SDTM Rules Sub-Team

• Introducing the Team• Proposed 2014 Deliverables• Progress so far…• INTRAChange Topics

Rules Sub-Team SOW – ‘Focus and Simplify’ Issues/ Questions

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Sub-Team Membership (so far)

• Stetson Line – Amgen • Tom Guinter – Independent • Janet Reich – Amgen• Max Kanevsky – Pinnacle21 • Sergiy Sirichenko – Pinnacle21 • Scott Bahlavooni – Biogen IDEC • Anne Russotto – Celgene • Carlos Radovsky – etera solutions• Bess LeRoy – Cpath.org• Gary Walker – Quintiles• Dan DiPremio – BioMarin• Sue Sullivan – d-Wise Technologies

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Proposed Sub-Team Goals

• Comprehensive SDTM IG v3.2 Validation Rules

• SDTM Validation Rule Implementation Guide

(Documents rule metadata and usage to enable SDS sub-teams to publish standard validation rules as part of future IGs).

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© CDISC 2014

Draft 2014 Sub-Team Milestones• Q1 2014

Sub-team Kickoff /Member orientation/ assignments SDTM IG v3.2 – DM Validation Rules Draft

• Q2 2014 SDTM IG v3.2 – Events/ Interventions Domains Validation Rules Draft SDTM Validation Rules IG Draft Check-in with SDS LT/ Share Team

• Q3 2014 SDTM IG v3.2 – Findings Domains Validation Rules Draft SDTM IG v3.2 – Findings About Domains Validation Rules Draft SDTM IG v3.2 – Other Special Purpose Domains Validation Rules

Draft• Q4 2014

SDTM IG v3.2 Validation Rules (submitted for public comment) SDTM Validation Rule Implementation Guide (submitted for public

comment)

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© CDISC 2014

Progress to Date

• Charter Approved

• Rules Sub-team Wiki set-up

• Extraction DM Pilot Rules template developed SDTM 1.4/SDTMIG 3.2 DM Rules extracted

• Analysis ongoing

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SDTM Validation Rules Wiki Space

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Rules Template – ‘Metadata Model’

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Working Model Pilot – DM Rules

• Objective: to get many different perspectives and experiences in order to refine the approach for the remaining domains/ observation classes. Pilot Exercise – DM Domain

• Using draft rules template extract all text that may indicate DM rules from SDTM 1.4/SDTMIG 3.2

• Record all potential interpretations• Reconciliation team to harmonize and consolidate• Full team review of rule metadata and potential

interpretations

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© CDISC 2014

Rules Team Scope

• Extract all business logic and data conformance rules? What about data quality? Is the output expected to be comprehensive or only

what is not captured e.g. DDT attributes, structural SDTM compliance? Inferred data quality?

• Rules metadata model: English-like, not concerned with rigorous application of

CT or rule syntax? More principle than law.

VS. Consistent syntax and CT, but perhaps too granular,

lacking readability. More law than principle.

• Implementable in Share? Do we know?

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© CDISC 2014

Rules Questions

• Screen failures - expected to be included or excluded? Data for screen failure subjects, if submitted, should be

included in the Demographics dataset, with ARMCD = “SCRNFAIL" and ARM = “Screen Failure”

Conditional rule? Add parameter to TS?

• ACTARM, ACTARMCD – implementation in complex trials are problematic, and are values expected to match TRTxxA (ADaM)?

• Population flags – expected? Conditional rule? Add parameter to TS?

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© CDISC 2014

Rules Questions

• Professional patients, patients shopping sites/arms – multiple DM records?

• What is the rule? Additional guidance needed. Multiple records / different SUBJIDs VS. One record per patient/USUBJID

• Map secondary to SUPPDM

• Where can a variable be used? Class level rules?

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© CDISC 2014

Rules Questions

• Managing Duplicate Rules• Rules class heirarchies – e.g.

If Core Variable Status = Req then Variable must exist Vs. USUBJID must exist, ARM must exist, etc.

• Overall Guidance Heirarchy SHARE (Future)

• SDTM– Class

»Domain

• Can children refine / restrict parent rules?

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