Versions Compared

Old Version 4

changes.mady.by.user Lorraine Sobson

Saved on

compared with

New Version 5

changes.mady.by.user Diane Wold

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: added link to JIRA issue SDTM-797

The SDTM has been designed to accommodate the broadest range of human and nonclinical study data in a standardized manner. This document describes the basic concepts and general structure of the model. Individual IGs have been created to provide specific recommendations for numerous domains of data commonly collected in human, nonclinical, and medical device studies, identifying which variables from a general observation class may apply. 

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keySDTM-797
These IGs also describe basic assumptions and business rules, and provide numerous examples for mapping data to the standard format. Sponsors wishing to represent data in the standard formats should consult the IGs before preparing datasets based on the SDTM. The following implementation guides have been published by CDISC:

...