Versions Compared

Old Version 6

changes.mady.by.user Jon Neville

Saved on

compared with

New Version Current

changes.mady.by.user Lorraine Sobson

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

A trial design domain that contains one 1 record for each of the inclusion and exclusion criteria for the trial. This domain is not subject oriented.

TI contains all the inclusion and exclusion criteria for the trial, and thus provides information that may not be present in the subject-level data on inclusion and exclusion criteria. The IE domain (described in Section 6.3.4, Inclusion/Exclusion Criteria Not Met) contains records only for inclusion and exclusion criteria that subjects did not meet.

Example

Include Page
SDTM Example.TITrial Inclusion/Exclusion Criteria
SDTM Example.TITrial Inclusion/Exclusion Criteria

Pagenav