The New SDTMIG - Whats Different From Older Versions
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1
CDISC 2012
Presented by Dan Godoy (SDS Team Co-Lead)
2
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
3
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
CDISC 2012
Progress to-date
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CDISC 2012
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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CDISC 2012
SDTMIG 3.1.4 - Whats Different?No more annotations like the ones in SDTMIG 3.1.3
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CDISC 2012
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
CDISC 2012
SDTMIG 3.1.4 - Whats Different?Numbering schema simplified down to just Section number
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CDISC 2012
SDTMIG 3.1.4 - Whats Different?Simpler numbering schema = Removal of references
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CDISC 2012
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
CDISC 2012
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
CDISC 2012
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 (GodoyD@MedImmune.com)Barrie Nelson (BarrieN@amgen.com)
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
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