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  1. SDS Home on the CDISC Website
  2. SDS Home on the CDISC Wiki (Access may be restricted to SDS Team Members)

Leadership Team

  1. Janet Reich
  2. Mike Hamidi
  3. 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 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)
  • 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
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3 Comments

  1. Suggested changes:

    • Decide whether to do an update to the Metadata Submission Guideline 
    • Include a section on cross-team projects, or overhaul the current section on Collaborations.  Include the Variable Definitions project in that section.
    • Include a description of our relationship with the SDTM Governance Committee
    • Clarify whether the PGx and Medical Devices teams are SDS sub-teams or separate teams.  The SDTMIG-PGx and SDTMIG-MD are not listed among our responsibilities.
    • Drop mention of "Domain Development sub-teams".  At present most new domains are being developed by TA projects.
    • Update the name of the Rules team's deliverable (I'm pretty sure it's not SDTMIG Rules Guidance).
    • Revise the operating model.  We've moved to two kinds of meeting (SDSLT and full SDS) on alternating weeks and dropped the old "extended leadership team."
    • Stop using the terms "area lead" and "area teams" and clarify which current teams are active, and whether and under what name and charter those that remain should continue.  For instance, the old Questionaires area team has turned into a mostly-independent team with it's own process (COP-17), while the Oncology team could be either a project team with a charter to produce certain deliverables or could evolve into something like the QRS team, producing terminology "supplements" for various oncology response criteria.
    • Check with the people whose names are mentioned that they are the right people to list.  E.g., I think Carlo might be a de facto co-lead for the Rules team.
  2. A few comments....

    • I think revisiting the Metadata Submission Guidelines would be beneficial. This comes in terms of recent discussions around representation of ePRO data, in which, the source may be argued to be "eDT" or "CRF". An email was sent to the e-Data team to obtain additional regulatory information on the recommended approach. Nevertheless, sponsors who consider such an origin to be "CRF" have their respective screenshots appended to the existing unique CRF casebook for the acrf.pdf. Guidance around this would be useful, especially that the FDA SDTCG references the MSG.
    • Can we add a link to the respective high-level projects listed on this page?
    • 2016 product goals
    • Create and add the SDS LT roles and responsibilities document, which could also have its residence here.
    • This is not necessarily a topic for the charter, but a look into possible future work around creating SDRG.xml / ADRG.xml  formats. Since most of the underlying exchange formats are being driven via XML, this might be a worthwhile endeavor to research. This would obviously be a cross-organizational development process between CDISC and PhUSE.
    • In the products section perhaps we can link to the 2016 Technical plan --> 2016 Technical Plan and we can maintain that separately. That covers the main standards update but we should list additional projects here as well such as Principles for Domain Development.
    • Evaluate the current operating model - is it working?
    • The Scope mentions FDA but should also now reference PMDA
    • The collaborations section should mention PhUSE as we're looking to work more closely with them on co-sponsored projects