Transcript CDISC GUF 17-DEC-2012 -06 SDTM PvReusel
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
The Evolution of SDTM
What’s new?
Agenda
1
Overview 2 SDTM 3.1.3
3 What’s next?
Agenda
1 Overview
2 SDTM 3.1.3
3 What’s next?
Overview of CDISC Models
DEC 2012 Content Standards Technical Standards Semantics Therapeutic Areas Upcoming
Updates over time
Content Standards Technical Standards
ODM v1.1
2002 / 2003 SDTM v1.0
SDTM IG v3.1
ODM v1.2
SDTM v1.1
SDTM IG v3.1.1
Define.xml
v1.0
ODM v1.2.1
2004 2005
Semantics Therapeutic Areas
ODM v1.3
ADaM v2.0
2006 BRIDG v1.1
BRIDG v1.0
SDTM v1.2
SDTM IG v3.1.2
CDASH v1.0
BRIDG v2.1
ADaM v2.1
ADaM IG v1.0
ADaM Val. Checks v1.0
BRIDG v3.0.2
ODM v1.3.1
BRIDG v3.0.1
BRIDG v2.0
BRIDG v1.1.1
BRIDG v3.0
BRIDG v2.2
Protocol Model v1.0
2007
DEC 2012
2008 2009 BRIDG v3.0.3
2010 … Define.xml
v2.0
SHARE PKD SDTM v3.1.2
Am.1
Alzheimer v1.0
SDM.XML
v1.0
ADaM Val.
Checks v1.1
CDASH v1.1
SEND v3.0
Virology Parkinson’s Disease Devices BRIDG v3.2
ADaM Val. Checks v1.2
SDTM v1.3
SDTM IG v3.1.3
Tuberculosis Pain PRM Toolset v1.0
CDASH UG v1.0
BRIDG v3.1
Healthcare Link CDASH v1.2
SDTM IG v3.1.5
SDTM IG v3.1.4
CV Imaging Schizo phrenia SEND v3.1
SDTM.xml
v1.0
Imaging Cardio vascular Alzheimer v1.1
ADaM IG v1.1
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 SDTM 3.1.3
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 RSCAT is used to identify the criteria used in the assessment of response Test and result (Controlled Terminology) Assessor Role
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
• No information – Invalid – – – • • • Other – Positive infinity – Negative infinity Unencoded Derived Unknown • • • • Asked but unknown – Temporarily unavailable Not asked Quantity sufficient Trace Masked Not applicable Code of the term in TSVAL Name + version number of the Reference Terminology from which TSVALCD is taken Null flavor for the value of TSPARM: to be populated if TSVAL is null
Agenda
1 Overview 2 SDTM 3.1.3
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 Imaging (CT Modality) CardioVascular Alzheimer’s Disease User Guide V1.1
Schizophrenia CFAST Asthma CV Imaging CFAST Diabetes Dec 2012 Mar 2013 Apr 2013 May 2013 Aug 2013 Aug 2013 Sep 2013 Dec 2013
Questions ?
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