Post on 14-Dec-2015
Update on CDISCTerminology Activities
RCRIM Vocab Session (Q4)14 January 2009, Orlando
Bron Kisler (CDISC)
Terminology Snapshot
• Primary Objective: to define and support the terminology needs of the CDISC models across the clinical trial continuum (SDTM → CDASH)
• Focus on “standard” terminology codelist development and publication, beginning with SDTM version 3.1.1
• Key partnership with US National Cancer Institute Enterprise Vocabulary Services (NCI EVS) with terms coded in NCI Thesaurus
• Contribute to external harmonization activities ISO, FDA, HL7 RCRIM, NCI, etc.
• http://www.cancer.gov/cancertopics/terminologyresources/CDISC
• SDTM Packages 1, 2A, 2B: 49 code lists with ~1750 controlled terms distributed across SDTM
• Labtest Packages 1 & 2: single code list with 365 controlled terms for Laboratory Test Results (commonly used for Analytes)
• SDTM Package 3: 6 code lists with 70 controlled terms, including Specimen Type and Specimen Condition; also includes 2 CDASH-specific code lists; finalized and being moved into production
• Labtest Package 3: Additional 180 controlled terms for Laboratory Test Results; finalized and being moved into production
SDTMIG v3.1.1 Terminology(production ~2500 terms)
• CDASH Clinical Data Acquisition Standards Harmonization:– CDASH Version 1.0 released October 2008– With few exceptions, SDTM terminology aligned with
CDASH requirements
• SEND Standards for the Exchange of Non-Clinical Data: – Gap analysis with SDTM Terminology complete;
significant overlap and reuse of SDTM terminology– Novel terminology developed (~640 new “draft” terms)
for SEND IG and regulatory pilots with focus on Species, Strains and Biospecimens
Harmonization Activities…Internal
CDISC-FDA-NCI EVSTerminology Harmonization
NCI Thesaurus
http://www.cancer.gov/cancertopics/terminologyresources/ http://www.cancer.gov/cancertopics/terminologyresources/
SDTM v3.1.1SDTM v3.1.1
CDASH, SENDCDASH, SEND
SPLSPL
RPS, ICSRRPS, ICSR
• ISO Technical Committee 215 WG-6 IDMP Projects; Units of Measurement – finalized 11240 CD ballot document
• HITSP Harmonization Subcommittee: Gender, Marital Status, Route of Administration, Body Site
• Joint Initiative Council (ISO, CEN, HL7, CDISC and now IHTSDO-SNOMED CT)
• FDA Projects (ICSR, RPS)
Harmonization Activities…other