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Warning
titleSDS Charter Link Accessibility

There are multiple referential links provided within this charter. Some of the associated links are public, but others (i.e., with an asterisk*) are limited to SDS team members. If you wish to join the SDS team as a volunteer, please visit this page here to get started.




SDS
  1. SDS Home on the CDISC Website
  2. SDS Home on the CDISC Wiki (Access may be restricted to SDS Team Members)
Leadership Team
  • Janet Reich (Current - 2019)
  • Mike Hamidi (Future - 2020)
  • Christine Connolly

SDTM Area / Project Leads

Interventions, Events and FA

Janet Reich & Madhavi Vemuri

PGx

Joyce Hernandez

Oncology

Barrie Nelson, Melanie Paules & Amy Adyanthaya

QRS

Gary Cunningham & Steve Kopko, Bess LeRoy, Jon Neville

RESPONC

Mike Hamidi & Richard Lewis

Business Rules

Stetson Line

 

Cross-Team Liaisons

FDA: TBD& Helena Sviglin

Controlled Terminology: TBD

Devices: Kit Howard

Team Mission

To develop and maintain a standard model and implementation guides that support more consistent and effective integration, aggregation, and submission of tabulation data from human clinical trials to facilitate FDA reviews and increase the value of collected research data.

Scope

The SDS Team develops standards for the submission of tabulation data from human clinical trials.  Since its inception, the SDS Team has worked to develop data domain models to support the Safety Domains listed in the 1999 FDA Guidance Documents from CDER & CBER, and continues to develop new or enhanced domain models through Study Data Tabulation Model (SDTM), as well as its drug- and biologics-focused Implementation Guide (SDTMIG).

The SDS team maintains the SDTMIG, Metadata Submission Guideline, and SDTMIG-AP, in alignment with the CDISC Strategy, by organizing its constituent members into relevant sub-teams to deliver domain models that meet growing data standardization needs from FDA, as well as key therapeutic-area-focused and collaborative organizations such as TransCelerate BioPharma.

 

The SDS Team is also looking to directly support C-FAST Therapeutic Area Standards products.

2017 Product Goals

The SDS Team will agree and implement its 2017 SDS Team - Project Delivery Plan, targeting to deliver:

  • Update to the Study Data Tabulation Model (SDTM v1.7)
    • Update to the
    • (Future - 2021)
    SDS Sub-team Leaders

    Team leaders are listed in the SDS sub-teams and collaborations table.

    SDS Team Liaisons to the GGG

    • Kristin Kelly

    • Ellina Babouchkina

    • Susan Tierney

    Deliverables
    • Study Data Tabulation Model Implementation Guide (SDTMIG
    v3.3)
  • Conformance Rules update for SDTM v1.7/SDTMIG v3.3
  • Update to the Metadata Submission Guideline (MSG v1.0)
    • ): Human Clinical Trials
    • SDTMIG Conformance Rules

    • SDTMIG for Associated Persons (AP)

    • SDTMIG for Medical Devices (MD)

    • SDTMIG for Pharmacogenomic/genetics (PGx)

    • Metadata Submission Guidelines (MSG) for SDTMIG

    • Oncology Supplements

    • Questionnaires, Ratings, Scales (QRS) Supplements



    Team Mission

    The SDS team develops and maintains standards for representing study data from human clinical trials and other research collaborations. The SDS team seeks continuous improvement and strives to increase the value of standardized study data for greater interoperability and accessibility by academic researchers, healthcare organizations, sponsors, and global health authorities.

    Scope

    The SDS team scope focuses on SDTM implementation guides for human clinical trial data. Each implementation guide (and its associated SDTM) describes the organization, structure, and format of the standardized data to support use by academic researchers, healthcare organizations, sponsors, and/or global health authorities.

    Operating Model
    • Working meetings to plan for future projects and content for industry stakeholders
    • A predictable and open forum for SDS team members to raise concerns/issues, provide feedback, identify cross-standard discrepancies (e.g., CDASH, CT), propose solutions, support development of content, and aid in the review and disposition of content for publication
    • Communicate across and manage all associated SDS sub-teams
    • Provide the Global Governance Group (GGG) updates to the wider SDS team members
    • Aid in on-boarding and mentoring SDS volunteers by providing a transparent and inclusive development culture
    Additional Resources



    Stakeholders
    • Regulatory Authorities (e.g., FDA, PMDA)
    • Standards & Related Organizations (e.g., HL7, LOINC, WHO, UMC, PhUSE)
    • Pharmaceutical/Biotech, Medical Devices, Real World Devices
    • Contract Research Organizations
    • Software Development Organizations
    • Consultants, Programmers, Statisticians, and other related Subject Matter Experts
    • Academic and Scientific Communities
    • Healthcare Organizations
    Cross-Team Collaborations

    The SDS team works closely across CDISC teams to ensure consistency, clarity, and to support development requirements of SDS deliverables.

    A list of cross-team collaborations (and SDS subteams) are listed on the SDS Wiki Home page.

  • The SDTMIG Rules Guidance (v1.0)
  • Intermediate provisional domain models (more to be defined)
  • Cascade CDISC values and develop SDTM modeling principles to facilitate decision making.
  • Improve CDISC wiki organization (eg, from team site and charter, to cross-team sites/charters, to CDISC Technical Plan).
  • Develop a library of examples, concept maps, decision trees as supplemental documents for user community reference.
  • White Paper on Race & Ethnicity

    • Other Major Project(s)

    The SDS Team will begin a project to load SDTM content into SHARE in 2015, and will also initiate the creation and implementation of several new domains, enhancements, and/or corrections to previously published sections, and other incremental content targeted for inclusion on the next release of the SDTMIG (v 3.3). Domains may be released in batches for review and provisional use prior to 3.3.

    These updates may be originated from previously existing plans, or as a direct result of Therapeutic Area Project needs.  Calls for volunteers will be issued to create SDTM Domain Development sub-teams.

    Stakeholders/Constituency

    • Regulatory Authorities
    • Standards Development Organizations
    • Pharmaceutical Sponsors
    • Medical Devices, Diagnostics

    Contract Research Organizations & Consultants

    Collaborations

    The SDS Team works closely with CDISC Teams who utilize or leverage the SDTM standard to develop their own IGs (e.g., SDTM Governance, SEND, ADaM, Devices, CDASH, PGx, XML Technologies).

    The SDS Team is also a strong contributor to BRIDG, SHARE, and TA Project Teams

    Operating Model & Meetings

    • Full team is divided into sub-teams to deliver one or more components from the 2016 SDS Team - Project Delivery Plan to effectively maintain the SDTM, SDTMIG, and SDTMIG-AP
    • Sub-teams set own meeting schedule, and mechanism to report progress through their  Lead(s)
    • SDTM Area Leads ensure consistency across SDTM Sections/domains under their care, and report maintenance progress up to SDS LT
    • SDS LT regularly engages with SDTM Area Leads to share CDISC Updates & Review deliverables against agreed 2015 SDS Team - Project Delivery Plan
    • Key meetings on Mondays 11am-12:30pm Eastern US Time 
      • 1st & 3rd Monday SDS LT
      • 2ND & 4TH Monday – SDS LT, SDTM Area Leads & SDTM Experts and Liaisons
    Quarterly meetings w/ full SDS Team, including volunteers