SDTM Area / Project Leads
Interventions, Events and FA
Janet Reich & Madhavi Vemuri
Barrie Nelson, Melanie Paules & Amy Adyanthaya
Gary Cunningham & Steve Kopko, Bess LeRoy, Jon Neville
Tom Guinter & Richard Lewis
FDA: ?? & Helena Sviglin
Controlled Terminology: Bernice Yost
Devices: Kit Howard
Team MissionTo 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.
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.
2016 Product Goals
The SDS Team will agree and implement its 2016 SDS Team - Project Delivery Plan, targeting to deliver:
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.
Contract Research Organizations & Consultants
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