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RCRIM Vocab-BRIDG Session

Wednesday, Session Q219 September 2007

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Agenda 11:00–11:30 am (BRIDG Update) 11:30 am – 12:10 pm (Terminology Update)

ISO / ICH Meeting in Brisbane SDTM Terminology Projects Key Harmonization Activities / CDISC

INTRAchange Meeting 12:10–12:30 pm (CV & TB Project Report)

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BRIDG Update(Julie Evans, Smita Hastak)

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Terminology Update(ISO TC 215 Working Group 6

meeting in Brisbane)

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Terminology Update(SDTM Terminology Projects)

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Snapshot – CDISC/RCRIM Terminology

Formalized CDISC Terminology Program in 2005 Combined HL7 RCRIM Vocab & CDISC Terminology

teams to ensure common development and harmonization through joint process

Primary Objective: to define and support the terminology needs of the CDISC models and RCRIM projects across the clinical trial continuum (e.g. SDTM → CDASH)

Terminology activities comprised of 70+ team members, distributed across 4 project teams that include international representation

Key Partnership with US National Cancer Institute Enterprise Vocabulary Services (NCI EVS)

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Primary Driver(Proposed Rule)

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.

Federal Register / Volume 71, No. 237 / dated…Monday, December 11, 2006

Federal Register / Volume 71, No. 237 / dated…Monday, December 11, 2006

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SDTM Package-1: 30 code lists & more than 700 controlled terms – Now in productionhttp://www.cancer.gov/cancertopics/terminologyresources/

Labtest: single code list with 92 controlled terms – Now in production 250+ additional Analyte terms in

development and available for public review this month

SDTM Package-2A: 12 code lists & more than 600 controlled terms for ECG, Con Meds, Drug Exposure and Substance Use, including Units of Measure and Frequency – completed Public Review

SDTM Package-2B: 17 code lists & 1000+ controlled terms for AE, Physical Exam, Vital Signs and Subject Chars, including Anatomical Location – in development

SDTM Terminology Projects

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Core Working Principles

Evaluate and/or utilize existing terminology 1st

Expand existing vocabularies where incomplete, working with vocabulary developer / owner

Harmonize across CDISC Models and with pre-existing vocabulary initiatives (via RCRIM)

Ensure terminology recommendations suit international needs for global organizations and projects

Ensure a controlled and sustainable “open source” environment and infrastructure for production terminology supporting terminology evolution

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Collaboration with NCI EVS

NCI Enterprise Vocabulary Services (EVS) has committed expertise and dedicated resources and is making a significant investment in the CDISC Terminology Program as well as RCRIM and FDA Vocabulary Initiatives (SPL, ICSR, RPS, CDRH Healthcare Devices)

CDRH = Center for Devices and Radiological HealthRCRIM = Regulated Clinical Research Info. Management

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Controlled Terminology “Nexus”

Vocabulary Developers

FDA & Academia

Global Pharma & CROs

International SDOs

Health Level Seven

(RCRIM TC)

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1. General: established processes for terminology development, harmonization and production; CDISC INTRAchange Meeting in July

2. CDISC Glossary: being loaded into terminology production environment (EVS) with SDTM terms

3. CDASH: aligning SDTM terminology projects with CDASH requirements…full harmonization planned for Q1 2008

4. SEND: gap analysis with SDTM underway and joint development activities launched this month

5. BRIDG/Protocol: harmonization activities being coordinated via RCRIM Technical Committee

6. Global activities…ISO/ICH and possibly WHO

SEND = Standard for Exchange of Non-clinical DataCDASH = Clinical Data Acquisition Standards Harmonization

Harmonization Activities

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CDASH-SDTM Terminology CDASH “Streams”CDASH “Streams” SDTM Term. “Projects”SDTM Term. “Projects”

CDASHPackage-1

CDASHPackage-1

SubjChars

ConMedsAE

Demog

PE/VS

MedHxIncl/Excl

SubstUse

ProtDevs

Disp.EndStudy

DrugExp

LabECG

CDASHPackage-2

CDASHPackage-2

CDASHPackage-3

CDASHPackage-3

CDASHPackage-4

CDASHPackage-4

SDTMPackage-1

SDTMPackage-1

* IN PRODUCTION *

30 Terminology codelists broadly distributed

across SDTM

* IN PRODUCTION *

30 Terminology codelists broadly distributed

across SDTM

SDTMLabtestSDTMLabtest

* IN PRODUCTION *

1 Terminology codelist with 100 terms; 200+

terms in devel.

* IN PRODUCTION *

1 Terminology codelist with 100 terms; 200+

terms in devel.

SDTMPackage-2A

SDTMPackage-2A

PUBLIC REVIEW(closed)

ECG, ConMeds, Drug Exp and Subst Use

PUBLIC REVIEW(closed)

ECG, ConMeds, Drug Exp and Subst Use

SDTMPackage-2B

SDTMPackage-2B

IN DEVELOPMENT

PE / VS, SubjChars, AE and Race

IN DEVELOPMENT

PE / VS, SubjChars, AE and Race

In developmentIn development

In developmentIn development

In developmentIn development

In developmentIn development

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Terminology Priorities (2007-early 2008)

Finalize production release of Labtest, SDTM Package 2A and SDTM Package 2B terminology sets

Support HL7 RCRIM-specific projects (Lab-based AE Assessment, Pharmacy SIG-CHI activities) and other projects related to global disease-specific data standards (e.g. CV, TB)

Scope, support and harmonize with other priority projects – CDASH, SEND, BRIDG, etc…

Harmonize with and support new global terminology projects such as those initiated by ISO, ICH & WHO

Develop user guidelines for production terminology access, download and implementation & develop process for terminology change control

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CV & TB Project Update(Brian McCourt, Anita Walden)