Update on CDISC Terminology Activities RCRIM Vocab Session (Q4) 14 January 2009, Orlando Bron Kisler (CDISC)

Slides:

Advertisements

Similar presentations

HL7 ICSR DSTU Update FDA progress since last working group meeting: –Completed mapping to all FDA AE programs, data collection forms and E2B –Completed.

Advertisements

HL7 Version 3 Laboratory Result-based Adverse Event Assessment Message Specifications RCRIM Technical Meeting September 18, 2007 Jennifer Neat Project.

HL7 January Working Group Meeting

1 HL7 Jan 2007 Working Group MeetingsPharmacogenomics Update RCRIM TC Philip M. Pochon Covance Enterprise Architecture.

Enterprise Vocabulary Services National Cancer Institute

INTERNATIONAL HEALTHCARE STANDARDS LANDSCAPE

11 SHARE S&V Document and the Pilot An Update on CDISC SHARE January 2010 Bron W. Kisler.

Joint TC Meeting: EHR – RCRIM RCRIM Overview HL7 Working Group Meeting January, 2007 Presented by: Ed Tripp Program Director, eSubmissions Abbott (RCRIM.

2006 European Interchange: RCRIM Meeting RCRIM Vocab & CDISC CT Initiative: Overview and Update Bron Kisler, CDISC Terminology Team Lead.

CDISC Content to Message HL7 Development Overview Jason Rock

1 HL7 Jan 2010 Working Group MeetingsCTLAB Pharmacogenomics Update JOINT RCRIM and CG Session CTLAB Message Pharmacogenomics Results Overview.

HL7 Working Group Meeting Orlando, Florida 14 January

Emerging Technologies Semantic Web and Data Integration This meeting will start at 5 min past the hour As a reminder, please place your phone on mute unless.

What’s New with CDISC Wayne R. Kubick CDISC CTO.

Kendle Implementation of Clinical Data Acquisition Standards Harmonization Dr Elke Sennewald Kendle 9th German CDISC User Group Meeting Berlin, 28 September.

BRIDG Update Project Description/Scope As a catalyst for productive collaboration, CDISC brings together individuals spanning the healthcare continuum.

CDISC Standards: Connecting Clinical Research and Healthcare

© CDISC: Global Approach To Accelerating Medical Research.

Specimen-Related Classes in BRIDG BRIDG Overview for HL7 O&O WG Conference Call July 1, 2015 Wendy Ver Hoef NCI Contractor.

Bay Area CDISC Implmentation Network – July 13, 2009 How a New CDISC Domain is Made Carey Smoak Team Leader CDISC SDTM Device Team.

Harmonization of SHARPn Clinical Element Models with CDISC SHARE Clinical Study Data Standards Guoqian Jiang, MD, PhD Mayo Clinic On behalf of CDISC CEMs.

Diastolic Blood Pressure C25299 C25299 CDISC VSTESTCD = “DIABP” Blood Pressure C54706 The pressure of the circulating blood against the walls of the blood.

Accenture Accelerated R&D Standards Metadata Management – version control and its governance Kevin Lee CDISC NJ Meeting at 01/28/2015 We help our Clients.

HL7 Study Data Standards Project Crystal Allard CDER Office of Computational Science Food and Drug Administration February 13,

 BRIDG R3.0.2 was released in August 2010  The BRIDG Model passed the initial ISO Joint Initiative Council ballot as a Draft International Standard (DIS)

CDISC XML Technologies Standards Development An Update Sam Hume

1 Health Level Seven (HL7) Report Out Population Science and Structured Documents Workgroup (SDWG) Riki Ohira September 22, 2011.

Second Annual Japan CDISC Group (JCG) Meeting 28 January 2004 Julie Evans Director, Technical Services.

HL7 RCRIM Meeting: 9 January 2007 CDISC-RCRIM Vocab Update: Related CDISC Terminology Projects Bron Kisler, CDISC Terminology Program Director

1 RCRIM Vocab-BRIDG Session Wednesday, Session Q2 19 September 2007.

© CDISC 2011 Joint Initiative Council 18 October 2011 Bron Kisler, VP, Strategic Initiatives, Current JIC Leader Rebecca D. Kush, PhD, President and CEO,

Public Health Reporting Initiative: Stage 2 Draft Roadmap.

RCRIM Projects: Protocol Representation and CDISC Message(s) January 2007.

RCRIM Off-cycle Meeting Barbara Tardiff, Randy Levin and Ed Tripp, co-chairs.

Dave Iberson-Hurst CDISC VP Technical Strategy

1 JIC SDO Standards Development Processes Prepared by Dave Iberson-Hurst, CDISC 19 th January 2010 Second Draft.

Regulated Product Submission HL7 Update Wednesday January 10 th, 2007 Jason Rock

Health IT Workforce Curriculum Version 1.0 Fall Networking and Health Information Exchange Unit 3b National and International Standards Developing.

CDISC©2009 February CDISC INTRAchange Carey Smoak Device Team Leader Li Zheng Submission Data Standards Team Member Thurday, April 2, 2009.

1 Healthcare Information Technology Standards Panel Care Delivery - IS01 Electronic Health Record (EHR) Laboratory Results Reporting July 6, 2007.

Ongoing/Planned Activities for Week of 4/29 Final UCR Crosswalk due COB 4/30 Hold two working sessions to complete UCR Crosswalk on 4/30 Hold working session.

BRIDG Update January HL7 Working Group Meeting 15 January

CDISC Update December 2007 / January 2008 Pierre-Yves Lastic, PhD CDISC Board of Directors & E3C February 5, Paris.

Ongoing/Planned Activities for Week of 4/22 Initial feedback on UCR Crosswalk due COB 4/23 Hold working session to continue filling out the UCR Crosswalk.

BRIDG Update HL7 Working Group Meeting Lake Buena Vista, FL 17 May, 2011.

FDA Standards Development and Implementation Randy Levin, M.D. Director, Office of Information Management Center for Drug Evaluation and Research Food.

Ongoing/Planned Activities for Week of 4/29 Final UCR Crosswalk due COB 4/30 Hold two working sessions to complete UCR Crosswalk on 4/30 Hold working session.

CDISC – 17/12/2012 Carine Javierre Nathalie SABIN.

Emerging Technologies Semantic Web and Data Integration This meeting will start at 5 min past the hour As a reminder, please place your phone on mute unless.

1 CDISC HL7 Project FDA Perspective Armando Oliva, M.D. Office of Critical Path Programs FDA.

Ballot Reconciliation Meeting Notes 1.Ballot Tally & Reconciliation a.CTLaboratory Release 3 / HL7 Version 3 Standard: Periodic Reporting of Clinical Trial.

Updates on CDISC Activities

BRIDG Update May HL7 Working Group Meeting 5 May

BRIDG Update HL7 Working Group Meeting San Diego, California 13 September 2011 Tuesday Q2, 11-12:30.

BRIDG Update RCRIM Working Group Meeting Rio de Janeiro 17 May 2010 Julie Evans Senior Director, Technical Services, CDISC Wendy Ver Hoef Senior Analyst,

CDISC Controlled Terminology HITSP Harm. Subcommittee 1 October 2008 Bron Kisler (CDISC)

© CDISC 2015 Paul Houston CDISC Europe Foundation Head of European Operations 1 CTR 2 Protocol Representation Implementation Model Clinical Trial Registration.

Submission Standards: The Big Picture Gary G. Walker Associate Director, Programming Standards, Global Data Solutions, Global Data Management.

CDISC Controlled Terminology Initiative: An Overview

Paul Houston CDISC Europe Foundation Head of European Operations

Dave Iberson-Hurst CDISC VP Technical Strategy

CDISC Controlled Terminology

CDISC and related initativies

HITSP C80 / C83 Briefing and Update

Component 9 – Networking and Health Information Exchange

CDISC UK Network Jun-16 – Welwyn

Clinical Observation Interoperability March 18, 2008

Christopher G. Chute, M.D., Dr.P.H

HL7 Working Group Meeting RCRIM Technical Committee

Presentation transcript:

Update on CDISC Terminology 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 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.

ces/CDISChttp:// ces/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 EVS Terminology Harmonization NCI Thesaurus SDTM v3.1.1 CDASH, SEND SPL RPS, ICSR

ISO Technical Committee 215 WG-6 IDMP Projects; Units of Measurement – finalized 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

2009 Terminology Plan Refer to and discuss accompanying 2009 Terminology Project spreadsheet for CDISC, RCRIM and FDA