The New SDTMIG - Whats Different From Older Versions

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CDISC 2012

Presented by Dan Godoy (SDS Team Co-Lead)

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The New SDTMIG 3.1.4

Whats Different from Previous Versions

CDISC 2012

AgendaBackgroundProgress-to-DateSDTM 3.1.4 - Whats Different?

Key Features & Examples

Q&A

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CDISC 2012

Background

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CDISC 2012

BackgroundSDTMIG has traditionally been a single document

1 Table of Content (at top)

Numbering schema has been static, at 4 levels

Inconsistent domain numbering of domain sub-sections

Forcing new domains to be appended

Maintenance of pagination & references has been challenging

Done after everything is inserted

QC takes longer than it should

Document has become extremely large and difficult to update

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CDISC 2012

BackgroundSDS Team had become too large and inefficient

80+ members per meeting, difficult to maintain focus

Lots of moving pieces to review in single meeting

Bottom Line: 4+ years since last release

SDTMIG 3.1.3 was 1st attempt to mitigate challenges

Several post-3.1.2 publications tied to new release

Enhanced Trial Design

Oncology domains

Amendment 1 Updates to DM & AE

Annotations were quick win, but impossible to maintain for next release

Lots of single documents needed for simple read

Numbering schema no longer useful

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CDISC 2012= Released

Background

= Draft = Provisional

SDTM Area Code Title

Foundational Standards Implementation Guides (IGs) Therapeutic Area Project User Guides (UGs)

Asso ciate

d Pers on (AP IG)

Device s

Human Trials IG (SDTM-

IG)

Pharm aco

Genom ics IG

SEN D IG

Alzhei mer's Disea

se (AD) User

Guide v1.1

Biom arker

Cardi ovas cular (CV) User Guid

e

Legac y

Conv ersion

- Diabe

tes

Pa in Us er G ui de

Parkin son's Disea

se (PD) User

Guide

Polycy stic

Kidney Diseas

e (PKD) User

Guide

Schiz ophre

nia User Guid

e

Tube rculo sis

(TB) User Guid

e

Virolo gy

User Guide

Findings NEC

DA Drug Accounta bility Y

DD Death Details Y Y Y Y

MI Microscop ic Findings Y Y Y

MO Morpholo gy Findings Y Y Y Y Y

PE Physical Exam Y

RP Reproduc tive System Findings Y Y

SC Subject Character istics Y Y Y Y Y Y

SS Subject Status Y Y Y Y

New Operating Model rationale: It is a complex environment

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Progress to-date

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SDTM v1.3 SDTMIG v3.1.3

Timing Two-week public review April Final Posting July 2012

July 2012

Criteria Material had undergone public review and comments have been addressed. Content SDTM 1.2

Amendment 1 variablesOncology data items (LNKID,

LNKGRP, ACPTFL, EVALID)SEND data items (additions to Tables

2.2.1-2.2.5 and DM), POOLDEF, Trial SetsEnhanced TSRELSUB, RSUBJID

SDTMIG 3.1.2Amendment 1 updates to DM and AEOncology domains (TU, TR, RS)Enhanced TS

Progress to-date

CDISC 2012

SDTM v1.4 SDTMIG v3.1.4

Timing Summer 2013Criteria Material Publicly Reviewed in 3 Batches (Batch 3 available in early Fall 13)Content SDTM 1.3

New Device variablesNew EX variablesAssociated Person NSID

SDTMIG 3.1.3Death Details (DD)Exposure as Collected (EC) and EX

enhancementsHealthcare Encounters (HO)Immunogenicity domains (IS/SR)Microscopic Findings (MI)Morphology (MO)Procedures (PR)Reproductive Details (RD)Subject Status (SS)Associated Person IG (AP IG)Virology User Guide (VR, VF, VP)PGx User Guide

Progress to-date

CDISC 2012

SDTMIG 3.1.4 Whats Different?

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SDTMIG 3.1.4 - Whats Different?No more annotations like the ones in SDTMIG 3.1.3

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Modular approach

SDTMIG 3.1.4 - Whats Different?

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SDTMIG 3.1.4 Portfolio

Section 1-4Section 5 TOCSection 6 TOCSection 7 TOCAppendices

TOC DM DomainCO DomainSE DomainSV Domain

Section 5 TOC

Interventions TOCEvents TOCFindings TOC

Section 6 TOC

DMCO

SESV

Interventions TOC

Events TOC

Findings TOC

CMEX

SU

AEDS

MHDV

CE

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SDTMIG 3.1.4 - Whats Different?Numbering schema simplified down to just Section number

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SDTMIG 3.1.4 - Whats Different?Simpler numbering schema = Removal of references

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Ability to re-order alphabetically

SDTMIG 3.1.4 - Whats Different?

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SDTMIG 3.1.4 Portfolio

Events TOCAE

DS

MH

DV

CE

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Ability to easily insert new domains

SDTMIG 3.1.4 - Whats Different?

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SDTMIG 3.1.4 Portfolio

Events TOCAE

DS

CE

DV

MHHO

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Every Domain will have consistent sub-sections

Purpose Description of intended use and related background

Specification table of variables

Assumptions all clarifications, caveats, rules, exceptions, etc.

ExamplesPurpose will match Controlled TerminologyDomains will be issued as topic sets, for instance

Pharmacokinetics PP & PC

Microbiology MB & MS

Exposure EX & ECConsistent headers and footersPage Numbers relative to individual document

SDTMIG 3.1.4 - Whats Different?

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CDISC 2012

SDTM Publications & Schedule

New Versions of SDTM and SDTM-IG released 1-to 2 times a year

SDTM 1.3 and SDTM-IG 3.1.3 targeted for May July 12

SDTM 1.4 and SDTM-IG 3.1.4 targeted for Summer-Fall 13

New domains/vars will be posted for comments as they become available

New versions will link all previously published domains from last version

Enables Provisional standards

Useful for setting validation rules

E.g., SDTM 1.3 and SDTM-IG 3.1.3 linked Amendment 1

SDTMIG 3.1.4 - Whats Different?

CDISC 2012

Q&A

CDISC 2012 21

Thank You!

Interested in Joining the SDS Team?

Register through Volunteer link on CDISC website

Contact:Dan Godoy ([email protected])Barrie Nelson ([email protected])

Slide Number 1The New SDTMIG 3.1.4Whats Different from Previous VersionsAgendaBackgroundBackgroundBackgroundSlide Number 7Progress to-dateProgress to-dateProgress to-dateSDTMIG 3.1.4 Whats Different?SDTMIG 3.1.4 - Whats Different?SDTMIG 3.1.4 - Whats Different?SDTMIG 3.1.4 - Whats Different?SDTMIG 3.1.4 - Whats Different?SDTMIG 3.1.4 - Whats Different?SDTMIG 3.1.4 - Whats Different?SDTMIG 3.1.4 - Whats Different?Slide Number 19Q&ASlide Number 21