CDISC Controlled Terminology: Let s Speak the Same Language. CDISC User Group Meeting March 12, 2009

Transcription

1 CDISC Controlled Terminology: Let s Speak the Same Language CDISC User Group Meeting March 12, 2009

2 Agenda Key Terminology Objectives Key Drivers Terminology Production and Development Future Plans 2

3 Terminology Objectives Primary Objectives Define and support the terminology needs of CDISC standards starting with SDTMIG Focus on standard terminology codelist development and publication

4 Guiding Principles (1) Adopt Adapt Develop Philosophy Evaluate and/or utilize existing terminology first Expand existing vocabularies where incomplete, working with vocabulary developer / owner Harmonize across CDISC Models and with preexisting vocabulary initiatives

5 Guiding Principles (2) Address international needs for global projects and organizations Ensure a sustainable open source environment and infrastructure for production terminology supporting terminology evolution

6 NCI EVS Partnership Dedicated terminology experts and resources CDISC controlled terminology development, harmonization, publication and maintenance Established terminology infrastructure and standard operating procedures CDISC terms are coded and tagged in NCI Thesaurus

7 CDISC-FDA-NCI EVS Terminology Harmonization NCI Thesaurus

8 Agenda Key Terminology Objectives Key Drivers Terminology Production and Development Future Plans 8

9 Proposed Rule (key driver) Federal Register / Volume 71, No. 237 / Monday, December 11, 2006 The Food and Drug Administration is proposing to amend the regulations governing the format in which clinical study data and bioequivalence data are required to be submitted for new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs). The proposal would revise our regulations to require that data submitted for NDAs, BLAs, and ANDAs, and their supplements and amendments be provided in an electronic format that FDA can process, review, and archive. The proposal would also require the use of standardized data structure, terminology, and code sets contained in current FDA guidance (the Study Data Tabulation Model (SDTM) developed by the Clinical Data Interchange Standards Consortium) to allow for more efficient and comprehensive data review.

10 FDA PDUFA IV IT Plan excerpt For terminology standards, the FDA partners with the National Cancer Institute Enterprise Vocabulary Services (EVS). The NCI EVS hosts the FDA terminologies and makes them freely available to the public. NCI EVS supports FDA vocabulary initiatives Structured Product Label (SPL) Regulated Product Submission (RPS) Individual Case Safety Report (ICSR)

11 Agenda Key Terminology Objectives Key Drivers Terminology Development and Publication Future Plans 11

12 Modeled Domains - SDTMIG v3.1.2 Interventions Events Findings Special Purpose Con Meds Adverse Events ECG Demographics Exposure Disposition Incl/Excl Exceptions Comments Substance Use Medical History Labs Subject Elements Deviations Physical Exam Subject Visits Trial Design Trial Elements Trial Arms Trial Visits Trial Incl/Excl Trial Summary Clinical Events Questionnaire Relationships Subject Characteristics Vital Signs SUPPQUAL Drug Accountability RELREC Microbiology Spec. PK Concentrations Microbiology Suscept. PK Parameters Findings About

13 SDTM Terminology (1) Terminology Gap Analysis is preformed on a standard to identify terminology needs Identify a team lead Form a team composed of colleagues who have subject matter expertise Government Agencies Pharma/CROs Academia International Representation 13

14 SDTM Terminology (2) ~2500 production terms across 55 codelists These terms were developed to support SDTMIG v3.1.1 and CDASH v1.0 Terminology Request Mechanism Developed and Maintained by NCI EVS Accessed through the CDISC Website with a direct link to NCI EVS 14

15 POSITION Codelist (SDTM & CDASH VSPOS, EGPOS) Standard Terminology Codelist CDISC Controlled Terminology Sitting Prone Standing Supine Fowlers Semi-Fowlers Trendelenburg Reverse Trendelenburg Right Lateral Decubitus Left Lateral Decubitus

16 Agenda Key Terminology Objectives Key Drivers Terminology Production and Development Future Plans 16

17 Harmonization Activities Continue terminology development for SDTMIG v3.1.2 (Microbiology, PK, SE, FA) Complete CDASH-SDTM terminology alignment (early Spring 2009) Support and harmonize terminology with other maturing CDISC standards (e.g., SEND, ADaM) Align terminology with BRIDG model and to support CDISC-HL7 message project(s)

18 Harmonization Activities other FDA Projects (e.g., ICSR, RPS) US HITSP Foundation Harmonization Subcommittee: (e.g., Marital Status, Gender, Body Site, Route of Administration) ISO Technical Committee 215 WG-6 Identification of Medicinal Products (e.g., Units of Measure) Joint Initiative Council (ISO, CDISC, CEN, HL7 and IHTSDO)

19 Terminology Initiatives Through Time SDTMIG V Present Future NCI SDTMIG V3.1.1 CDASH NCI HL7 NCI HL7 HITSP SDTM V3.1.1 & V3.1.2 CDASH SEND New Domains in Dev Versioning Process NCI HL7 HITSP ISO JIC

20 How to Access Terminology 20

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23 How to Access Terminology 23

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27 Strength through collaboration. If you are interested in contributing to the CDISC Terminology Initiative, please contact me Chris Tolk Director, Terminology (203)