- SDS Home on the CDISC Website
- SDS Home on the CDISC Wiki (Access may be restricted to SDS Team Members)
- 2015 CDISC Technical Plan
Leadership Team
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SDTM Area Leads Findings NEC Randall Austin & Jan Hess Interventions, Events and FA Janet Reich & Madhavi Vemuri Lab Findings Joyce Hernandez & VACANT Oncology Barrie Nelson, Melanie Paules & Amy Adyanthaya Clinical Outcome Assessments & Classifications Gary Cunningham & Steve Kopko, Bess LeRoy, Jon Neville Special Purpose Tom Guinter & Richard Lewis Trial Design & IE Diane Wold & VACANT Business Rules Stetson Line |
SDTM Experts Gail Stoner Gary Walker Madhavi Vemuri |
Cross-Team Liaisons FDA: Ron Fitzmartin & Helena Sviglin SDS Volunteers: Naveed Khaja Controlled Terminology: Bernice Yost Devices: Carey Smoak |
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. |
2015 Product Goals The SDS Team will agree and implement its 2015 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. |
Stakeholders/Constituency
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
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