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
peter.van.reusel@businessdecision.com
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
peter.van.reusel@businessdecision.com
Sint-Lambertusstraat 141 Rue Saint-Lambert
1200 Brussels
www.businessdecision-lifesciences.com