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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)

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

  • Amy Palmer
  • Bernice Yost
  • Bess LeRoy
  • Bob Stafford
  • Cliff Reinhardt  Yun Lu
  • Dana Booth
  • Kim Minkalis
  • Diane Corey
  • Eanna Kiely (EU) 
  • Emily Hartley
  • Fred WoodJon Neville
  • Gary Cunningham
  • Amy Palmer
  • Rohit Dhanjal
  • Nate Freimark
  • Cliff Reinhardt  
  • Emily Hartley
  • Gloria Jones
  • Janet Siani
  • Jon Neville
  • Kim MinkalisJanet Siani
  • Kristin Kelly       
  • Bob Stafford
  • Eanna Kiely        
  • Madhavi Vemuri
  • Steve Kopko
  • Fred Wood
  • Mike Hamidi
  • Nate FreimarkSandy Lei           
  • Patricia Wozniak        
  • Bess LeRoy
  • Bernice Yost
  • Richard Lewis
  • Mike Hamidi
  • Richard Lewis
  • Rohit Dhanjal
  • Sandy Lei           
  • Steve Kopko
  • Yun LuGloria Jones

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 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
    • 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 – CDISC SDTMIG Questionnaires, Ratings and Scales Supplements.  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 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 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 domain representation (Q2 2015)
    • Provide consistency revisions in the QS/FT/CC 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)