Core Java

Clinical

SDTM

SDTM (STUDY DATA TABULATION MODEL)

Study Data Tabulation Model has been prepared by the Submissions Data Standards (SDS) team of the Clinical Data Interchange Standards Consortium (CDISC). It is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA). Tabulation datasets, which are electronic listings of individual observations for a subject that comprise the essential data reported from a clinical trial, are one of four types of data currently submitted to the FDA along with patient profiles, listings, and analysis files. By submitting tabulations that conform to the standard structure, sponsors may benefit by no longer having to submit separate patient profiles or listings with a product marketing application. SDTM datasets are not intended to fully meet the needs supported by analysis datasets, which will continue to be submitted separately in addition to the tabulations. Since July 2004, the FDA has referenced use of the SDTM in the Study Data Specifications for the Electronic Common Technical Document.

COURSE CONTENT

  • Introduction
  • Fundamentals of the SDTM
  • Submitting Data in Standard Format
  • Assumptions for Domain Models
  • Models for Special-purpose Domains
  • Domain Models based on the General Observation Classes
  • Trial Design Datasets
  • Representing Relationships and Data.

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