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  1. QRS Sub-Team Home on the CDISC Website
  2. QRS Sub-Team Home on the CDISC Wiki (Access may be restricted to QRS Sub-Team Members)
  3. 2015 CDISC Technical Plan

Leadership Team

QS: Gary Cunningham (The Griesser Group,

Steve Kopko (CDISC

)FT/CC: Bess LeRoy (C-Path), Jon Neville (C-Path

Consultant), Dana Booth (CDISC Consultant)

QRS Coordinator: Dana Booth (CDISC

)Team Characteristics

CDISC SDS QRS Sub-Team consists of a core team that develops enhancements to the Foundational SDTMIG QRS standard domains and manages the implementation of standard instruments to support therapeutic areas. The number of volunteer QRS Sub-Team members varies based on review needs.  Additional volunteers are welcomed to assist in the internal review of products prepared by the core team.

Core Team Members

Consultant)

Amy Palmer
Anoop Galhotra
Chenoa Conley 
Cliff Reinhardt 
  • Amy Palmer
  • Bernice Yost
  • Bess LeRoy
  • Bob Stafford
    • Cliff Reinhardt  
    Dana Booth
    Diane Corey
  • Eanna Kiely (EU) 
    • Emily Hartley
    Éanna Kiely
    Fred Wood
    Gary Cunningham
    Gloria Jones
  • Janet Siani
  • Jon Neville
  • Kim Minkalis
  • Kristin Kelly       
    • Madhavi Vemuri
    Graham Thompson
    James Kramer
    Jenny Zhang
    Joan W. Lippincott
    Jordan Li
    JörXg Sahlmann
    Karl Kennedy
    Kimberly Minkalis
    Kristin Kelly
    Lili Garrard
    Mahumood Hameed
    Marian Mullin Strazzeri
    Meghana Chalasani
    Michael Wise
    Mike Hamidi
    Nate Freimark
    Patricia Wozniak        
    Pujita Vaidya
    Richard Lewis
  • Rohit Dhanjal
    • Sandy Lei           
    Roberta Rosenberg
    Sara Jimenez
    Seema Sharma
    Smitha Karra
    Steve Kopko
    Yun Lu
    Swarupa Sudini
    Victoria Petrek
    Weiya Zhang
    Zhao Yang

    Team Mission

    Primary Objectives

    • Define and support the Questionnaires, Ratings and Scales (QRS) needs of CDISC standards based on the SDTMIG
      • Represented in the QS/FT/
    CC
      • RS Findings domains
    • Focus on developing standard QRS supplements for publication
    • Implementations will follow the current appropriate SDTM/SDTMIG published QRS domain models, including any domain assumptions
      • Implementations will follow CDISC
    Operating Procedure 017
      • COP Standards Development - 001
      • Implementation issues that identify gaps in the current published model will be addressed with the SDS Team for remediation
      • Implementations will be consistent with the SDTMIG, address copyright permission, use controlled terminology, harmonizing on the consistent inclusion of QRS variables and standards/best practices for the specific instrument being implemented
    • Process improvements to the QRS implementation process to keep pace with the development of CFAST Therapeutic Area Standards CDISC subject matter experts (i.e. ADaM, Terminology, and CDASH) will be consulted as needed for any input on implementation issues

    Scope

    The CDISC QRS Sub-Team supports the Questionnaires, Ratings and Scales needs of all CDISC standards (SDTM, CDASH, and ADaM) and all disease/therapeutic area standards. Based on the new instruments that need to be implemented, the sub-team publishes completed QRS Supplements each month. The sub-team manages QRS requests based on CDISC COP

    017

    001 – CDISC

    SDTMIG Questionnaires, Ratings and Scales Supplements

    Standards Development.  Supplements have about a 2-4 week implementation cycle after copyright permission is received and QRS terminology is released. All approved Supplements are stored on the CDISC

    ONEDRIVE

    QRS webpage for public access

    and accessible

    through the CDISC website.

    The QRS sub-team maintains its membership through careful selection of volunteer experts who can contribute to its various sub-teams with their technical or Therapeutic-based subject matter expertise.   

    2015

    2018 Deliverables

    Deliverables with Projected Target Dates for Public Review:  

    • Monthly QRS Supplement Package Updates
    (2015)
    • Update the SDTMIG Section 6.3 QS Domain to  indicate QRS concepts which currently include QS/FT/
    CC
    • RS domain representation
    (Q2 2015)
      • Provide consistency revisions in the QS/FT/
    CC
      • RS Domain Documents for understandability
    • Representing QRS Metadata
    (Q4 2015)

    Stakeholders/Constituency

    • Regulatory Authorities
    • Standards Development Organizations
    • Pharmaceutical Sponsors
    • Medical Devices, Diagnostics
    • Contract Research Organizations &
    • Consultants
    • Academic Researchers
    • Laboratories
    • Instrument Copyright Owners
    • Developers of Public Domain Instruments

    Collaborations

    NCI EVS, SDS, CDASH, ADaM, HL7

    RCRIM, CFAST Therapeutic Area standards and CDISC Operations. 

    Operating Model & Meetings

    • There is a need to develop new SDTMIG QRS Supplements for the many existing instruments used in research.  Most new disease standards have a potential set of instruments that need to be implemented in the appropriate domain as a Supplement.
    • The requests for these new QRS standards are made to the QRS Sub- Team through the TA standards projects and sponsors. 
    • The QRS Controlled Terminology Team meets regularly to address QRS terminology requests that come from the QRS Sub-Team. 
    • Other sub-teams teams are convened as needed based on requests.
    • Key weekly meetings:
    10am-11am ET 1st Wed.(EU)
    • 3pm-4:00pm ET 2nd-4th Wed. (US)