CDISC Controlled Terminology: Let s Speak the Same Language
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1 CDISC Controlled Terminology: Let s Speak the Same Language DCDISC User Network November 8, 2011 Chris Tolk Director, Terminology
2 Agenda Overview / Objectives Key Drivers Terminology Development SDTMIG Terminology v3.1.2 Harmonization Activities Terminology Projects 2011 How to Access Terminology 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 Overview / Objectives Key Drivers Terminology Development SDTMIG Terminology v3.1.2 Harmonization Activities Terminology Projects 2011 How to Access Terminology 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 Overview / Objectives Key Drivers Terminology Development SDTMIG Terminology v3.1.2 Harmonization Activities Terminology Projects 2011 How to Access Terminology 11
12 Controlled Terminology Development Terminology Gap Analysis is preformed on a standard to identify terminology needs Identify Team Leader Form Team Pharma / CROs Government Agencies Academia International Representative 12
13 Controlled Terminology Development Final Term Term Term Term Sponsor/ Institution Sponsor/ Institution Sponsor/ Institution Slide courtesy of Rhonda Facile 13
14 Terminology Group Internal CDISC Standards Development 6000 SDTM Terminology Numbers SDTM Terminology Numbers Q Q Q Q Q Q Slide Courtesy of Erin Muhlbradt (NCI-EVS) 14
15 Terminology Group Internal CDISC Standards Development 30 ADaM Terminology Numbers SEND Terminology Numbers ADaM Terminology Numbers SEND Terminology Numbers Q Q Q Slide Courtesy of Erin Muhlbradt (NCI-EVS) 15
16 SDTM Terminology ~10,000 production terms across 50 codelists These terms were developed to support SDTMIG v3.1.2, ADaM v2.0 CDASH v1.0 and SEND Terminology Request Mechanism Developed and Maintained by NCI EVS Accessed through the CDISC Website with a direct link to NCI EVS 16
17 Terminology Requests (Total) Type III Type II Type I Slide Courtesy of Erin Muhlbradt (NCI-EVS) 17
18 Codelist Use Code lists that are used for one domain Action Taken with study drug (AE domain) ECG Result (EG domain) Laboratory Test Code and Name (LB domain) Code lists that are used across multiple domains Units of Measure (CM, LB, EG) Anatomical Location (AE, PE, VS) Position (EG, VS) Route (CM, EX) No/Yes 18
19 POSITION Codelist (SDTMIG /CDASH & Harmonized with HL7) VSPOS, EGPOS Standard Terminology Codelist CDISC Controlled Terminology Sitting Prone Standing Supine Fowlers Semi-Fowlers Trendelenburg Reverse Trendelenburg Right Lateral Decubitus Left Lateral Decubitus Codelist = Value Set = Permissible Values
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22 Agenda Overview / Objectives Key Drivers Terminology Development SDTMIG Terminology v3.1.2 Harmonization Activities Terminology Projects 2011 How to Access Terminology 22
23 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 Subject Characteristics Vital Signs Drug Accountability Microbiology Spec. PK Concentrations Microbiology Suscept. PK Parameters Findings About Relationships SUPPQUAL RELREC
24 Code Lists in SDTMIG v3.1.2 Controlled Terms or Formats Column Variable Name Variable Label Controlled Terms or Format 24
25 Agenda Overview / Objectives Key Drivers Terminology Development SDTMIG Terminology v3.1.2 Harmonization Activities Terminology Projects 2011 How to Access Terminology 25
26 Harmonization - CDISC Models Data Sources Site CRFs Laboratories Contract Research Organizations Development Partners CDASH, LAB Operational Data Interchange & Archive: ODM, LAB Operational Database Standard Terminology Study Data Audit Trail Metadata ODM Submission Data Interchange & Archive: SDTM, ADaM SEND Submission Data CRT/Domain Datasets Analysis Datasets Metadata ODM = Operational Data Model SDM = Submission Data Model LAB = Laboratory Data Model ADaM = Analysis Data Models SEND = Standard for the Exchange of Non-clinical Data CDASH = Clinical Data Acquisition Standards Harmonization 26
27 Harmonization Activities - Internal Support and harmonize terminology with other maturing CDISC standards (e.g., SDTM, SEND, ADaM, CDASH) Support and harmonize terminology with new domain development (e.g., Devices, Oncology, Trial Summary Parameters)
28 Harmonization Activities other (1) 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, Dose Forms, Routes of Administration) Joint Initiative Council (ISO, CDISC, CEN, HL7 and IHTSDO)
29 Harmonization Activities other (2) C-Path - CAMD Using the SDTM to map existing data for Alzheimer s RTRN Working under a CRNFA to map data from 3 large clinical cardiovascular studies
30 Agenda Overview / Objectives Key Drivers Terminology Development SDTMIG Terminology v3.1.2 Harmonization Activities Terminology Projects 2011 How to Access Terminology 30
31 FDA Disease Projects TB Cardiovascular Terminology Plans 2011 Therapeutic Area Standards PKD Foundation Development of efficacy data elements and terminology for Polycystic Kidney Disease C-Path Parkinson s Disease Alzheimer s Disease Pain & Analgesics initiative with Univ. of Rochester New FDA Projects 31
32 Agenda Overview / Objectives Key Drivers Terminology Development SDTMIG Terminology v3.1.2 Harmonization Activities Terminology Projects 2011 How to Access Terminology 32
33 How to Access CDISC Terminology Go to CDISC Website Standards & Innovations Terminology 33
34 NCI EVS Website 34
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38 Strength through collaboration. If you are interested in contributing to the CDISC Terminology Initiative, please contact me Chris Tolk Director, Terminology (480)
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