The Evolution of SDTM What’s new?
Peter Van Reusel Business Unit Director Projects Business & Decision Life Sciences Tel +32 2 774 11 00 Fax +32 2 774 11 99 Mobile +32 476 545 917
[email protected] Sint-Lambertusstraat 141 Rue Saint-Lambert 1200 Brussels www.businessdecision-lifesciences.com
Agenda
1
Overview
2
3
SDTM 3.1.3
What’s next?
Agenda
1
Overview
2
3
SDTM 3.1.3
What’s next?
Overview of CDISC Models
Content Standards
Semantics
Technical Standards
Therapeutic Areas
DEC 2012
Upcoming
…
Updates over time
Define.xml v2.0
SHARE
DEC 2012
PKD Healthcare Link
Content Standards
Semantics
Technical Standards
Therapeutic Areas
CDASH v1.2 Virology Parkinson’s Disease Devices BRIDG v3.0.3
SDTM v1.2 SDTM IG v3.1.2 CDASH v1.0
SDTM v1.1 SDTM IG v3.1.1
SDTM v1.0 Define.xml SDTM IG v1.0 v3.1 ODM v1.1
/
ODM v1.2
2002
2003
2004
BRIDG v2.1
ADaM v2.1 ADaM IG v1.0
ADaM Val. Checks v1.0
Alzheimer v1.0
BRIDG v3.0.2
SDM.XML v1.0
ODM v1.3.1
ADaM Val. Checks v1.1
BRIDG v3.0.1
ODM v1.3
BRIDG v1.1
BRIDG v2.0
BRIDG v3.0
BRIDG v1.1.1
BRIDG v2.2
Protocol Model v1.0
2008
2009
2010
ODM v1.2.1
ADaM v2.0
BRIDG v1.0
2005
2006
2007
SDTM v3.1.2 Am.1
BRIDG v3.2 ADaM Val. Checks v1.2
SDTM IG v3.1.5
SDTM IG v3.1.4 CV Imaging Schizophrenia SEND v3.1
SDTM v1.3 SDTM IG v3.1.3
SDTM.xml v1.0
Tuberculosis
Cardiovascular
Pain PRM Toolset v1.0
Imaging
Alzheimer v1.1 ADaM IG v1.1
CDASH v1.1
CDASH UG v1.0
SEND v3.0
BRIDG v3.1
Standard Protocol Toolset
2011
2012
2013
Technical Plan Project Schedule
http://www.cdisc.org/stuff/contentmgr/files/0/5fbd2b7afd4cc3ae3274d97d44d7a8b0/misc/cdisc1012_2.pdf
Data Standards Governance
DATA GOVERNANCE PROCESS DEDICATED TEAM
Agenda
1
Overview
2
3
SDTM 3.1.3
What’s next?
IG Format • SDTMIG V3.1.3 is presented as an annotated version of SDTMIG V3.1.2. • Sticky Notes
– Used to indicate what has changed or what has been inserted
IG Format • Document Attachment Annotations – Document attachments are “pinned”
• Whole Section replacement – Sections blanked out due to comprehensive update
What’s new in 3.1.3? • SDTM V1.3 and SDTM IG V3.1.3: – New variables in general observation classes – SDTMIG V 3.1.2 Amendment 1 content added to IG – Inclusion of Oncology Therapeutic Area domains – Changes to the Trial Design section
– Document formatting updates
Oncology Domains • The tumor package consists of three SDTM Findings Domains: – TU : Tumor Identification – TR : Tumor Results – RS : Disease Response
• Typically combined during analysis
Oncology Domains
Tumor Identification (TU) • Represents data that uniquely identifies tumors Unique Tumor ID: • Internal or external Identifier (e.g. Medical Image ID number) • Sponsor-defined Identifier • Identifier to link to TR domain
Identification of: • Target • Non-Target • New tumors (e.g. RECIST)
Anatomical Location + Additional location variables • Laterality (LEFT, RIGHT, BILATERAL) • Directionality (UPPER, INTERIOR) • Portion or Totality (ENTIRE, SINGLE, SEGMENT)
Method
Assessor role
Tumor Results (TR) • Represents quantitative measurements and/or qualitative assessments Unique Tumor ID
Test and result (Controlled Terminology)
Method
Assessor role
New convention
Disease Response (RS) • Represents the response evaluation(s) Unique Tumor ID
Assessor Role
RSCAT is used to identify the criteria used in the assessment of response
Test and result (Controlled Terminology)
RELREC • Linking TU, TR and RS
--LNKID: one record in TU to many records in TR
--LNKGRP: one record in TR to many records in RS
Trial Summary Code of the term in TSVAL
Name + version number of the Reference Terminology from which TSVALCD is taken
•
No information – Invalid •
Other – –
Positive infinity Negative infinity
• •
Unencoded Derived
•
Asked but unknown
– Unknown –
• • •
Temporarily unavailable
Not asked Quantity sufficient Trace
– Masked – Not applicable
Null flavor for the value of TSPARM: to be populated if TSVAL is null
Agenda
1
Overview
2
3
SDTM 3.1.3
What’s next?
General Releases •
DEC 2012
Draft (for Review) – SDTM IG v3.1.4 Batch 1 – SDTM IG v3.1.4 Batch 2 (coming soon) – Define.xml v2.0
• Upcoming – – – – – – – –
ADaM IG v1.1 CDASH v1.2 Standard Protocol Concepts + IG SDTM.xml v1.0 SEND v3.1 BRIDG 4.0 SDTMIG 3.1.5 SDTM 1.5
SDTM IG V3.1.4 Batch 1 • Exposure Domains Supplement – New domain : Exposure as Collected (EC) – Clarifications of: • • • •
EX domain definition EXDOSU EXDOSE EXVAMT
– Standard representation of: • • • • •
collected doses not taken collected reason why a dose was not taken collected intended dose details concentration / dosage strength masked records
– Variables proposed for deprecation: •
EXDOSTOT, EXVAMT and EXVAMTU
SDTM IG V3.1.4 Batch 1 • Immunogenicity Domains Supplement – Immunogenicity Assessments (IS) •
Assessments determining whether a therapy provoked/caused/induced an immune response
– Skin Response (SR) • •
Dermal responses to antigens Findings About an Intervention –
Different domain code instead of FA
SDTM IG V3.1.4 Batch 1 •
Reproductive Details Domain – Captures all Reproduction details related to the subject in a FINDINGS domain – E.g.: • •
Subject’s reproductive ability History: number of previous pregnancies & number of births
Therapeutic Areas
DEC 2012
•
PKD
Dec 2012
•
Imaging (CT Modality)
Mar 2013
•
CardioVascular
Apr 2013
•
Alzheimer’s Disease User Guide V1.1
May 2013
•
Schizophrenia
Aug 2013
•
CFAST Asthma
Aug 2013
•
CV Imaging
Sep 2013
•
CFAST Diabetes
Dec 2013
Questions ?
Thank you for your attention
Peter Van Reusel Business Unit Director Projects Business & Decision Life Sciences Tel +32 2 774 11 00 Fax +32 2 774 11 99 Mobile +32 476 545 917
[email protected] Sint-Lambertusstraat 141 Rue Saint-Lambert 1200 Brussels www.businessdecision-lifesciences.com
