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Update on the Study Data Tabulation Model for FDA Submissions
Public Meeting - Tuesday, February 1, 2005, Rockville, MD
The purpose of this public meeting was to review the current status of SDTM and discuss recent FDA experience and future plans that involve the standard. The meeting also included presentations from CDISC participants on the current state, future direction and implementation challenges of the proposed standard format, and describe experiences from sponsor representatives who have been preparing submissions using the SDTM.
Update on CDISC Study Data Tabulation Model - Randy Levin, FDA [PDF]
FDA Public Meeting: Study Data Tabulation Model Status Update - Wayne Kubrick, CDISC [PDF]
Trial Design Overview - Diane Wold, CDISC [PDF]
Applying the SDTM for Non-Clinical Data -- Fred Wood, CDISC [PDF]
Feedback from an SDTM Submission: A Sponsor Perspective -- William J. Qubeck, CDISC [PDF]
SDTM Underlying Principles, FAQS -- Tom Guinter, CDISC [PDF]
Implementing the SDTM -- Dan Godoy, CDISC [PDF]
Applying the SDTM to the Janus Data Warehouse -- Norman Stockbridge, FDA [PDF]
The Review of SDTM Datasets at CDER: A Clinical Reviewer's Perspective -- Armando Oliva, FDA [PDF]
SDTM for Nonclinical Data (SEND): An FDA Reviewer's Perspective -- Tom Papoian, FDA [PDF]
Analysis Data Submissions & Wrap-up of FDA perspectives -- Steve Wilson, FDA [PDF]