SDTM Validation Rules Sub-team Kickoff Meeting January 24 th, 2014.

SDTM Validation Rules

Sub-team

Kickoff Meeting

January 24th, 2014

© CDISC 2011

Meeting Agenda

• Introductions • Charter and Proposed 2014 Milestones• Working Model

Pilot Exercise Strategy and Key Assumptions Team Roles and Responsibilities

• Progress to date• Near-term Plan, Calendar of Events• AOB

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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

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© CDISC 2011

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 2011

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 2011

Proposed Working Model

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SDTM Validation Rules Sub-team Working ModelEx

tracti

on B

Ex

tracti

on A

Pu

blica

tion

Full T

eam

Phase

Identify Rules in IG, Populate

Metadata Template

Identify Rules in IG, Populate

Metadata Template

Reconcile and Harmonize Rules, Summarize Key

Issues

Team Review and Discussion

Rules Posted for Public Comment

© CDISC 2011

Working Model Pilot

• Objective is 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 2011

Working Model Assumptions

• Extraction teams working in parallel are likely to identify all potential rules – i.e. it is unlikely that all teams will make the same errors of omission.

• The Publication team will be another pair of eyes, in effect, when reconciling differences between the extraction teams’ efforts. This team will maintain the draft rules, controlled terminology lists and issue logs in preparation for discussion at the full team meetings and eventual publication.

• The full team will discuss escalated issues. If issues are not efficiently resolvable they will be documented as unresolved e.g. Parking Lot and escalated to the SDS LT as needed.

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© CDISC 2011

Working Team Responsibilities (proposed)

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• Rules Extraction Team A Analyze and extract rules from SDTM IG

• Rules Extraction Team B Analyze and extract rules from SDTM IG

• Rules Publication Team Analyze and align rules metadata from ID teams Govern rule classification CT as needed Document work stream deliverables and guidance

• Full Team Resolve issues or agree to escalate Review and finalize draft deliverables Status updates/adjustments to working plans as

needed.

© CDISC 2011

Progress to Date

• Charter revised and re-submitted To be reviewed at 10Feb SDS LT Meeting

• Rule Sub-team Wiki set-up Max – Demonstration

• Extraction Pilot Team Rules template developed SDTM 1.4/SDTMIG 3.2 DM Rules partial extraction Janet/Tom – walkthrough of template and pilot findings

so far

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© CDISC 2011

Near-term Calendar of Events

• 10Feb – DM Rules Due• 21Feb – DM Rules Reconciled/Final Draft• 25Feb – 27Feb CDISC INTRAchange

Sub-team update presentation (?) Opportunity to discuss/refine working model and rules

template

• 14Mar – Full Sub-team Meeting• 14Mar – SDTM Validation Rules IG TOC/plan• 11Apr – ‘A’ Team Events/Interventions Rules• 11Apr – ‘B’ Team Events/Interventions Rules

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© CDISC 2011

Action Items

• DM Pilot• Volunteers for Working Teams• Agenda for INTRAchange Activities• Next Full-team Meeting

March 14th?

• Other business?

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