Versions Compared

Old Version 20

changes.mady.by.user Kathleen Mellars

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.

The Inclusion/Exclusion Criteria (IE) domain is a findings Findings domain that contains criteria that cause the subject to be in violation of the protocol inclusion/exclusion criteria. The trial design domain TI (not shown here; see Section 3.3.1, Trial Design) is used to describe the criteria. One record for each of the inclusion and exclusion criteria for the trial are included in TI. This The TI domain is not subject oriented. The TI domain is described in the section on Trial Design. The TI domain is not shown here.          

Example

Include Page
CDASH Example.Subject Inclusion/Exclusion Criteria
CDASH Example.Subject Inclusion/Exclusion Criteria

Include Page
SDTM Example.Subject Inclusion/Exclusion
SDTM Example.Subject Inclusion/Exclusion

...