The Inclusion/Exclusion Criteria (IE) domain is a 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. The TI domain is not subject oriented.
Example
This is an example CRF used to collect subject inclusion/exclusion criteria.
Section 1
Order
Question Text
Prompt
Case Report Form Completion Instructions
Type
Collection Variable
Tabulation Target
Mapping Instructions
Controlled Terminology CodeList Name
Permissible Values
Pre-Populated Value
1
Were all eligibility criteria met?
Met Criteria
Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolled.
Text
IEYN
Not Submitted
Section 2
Order
Question Text
Prompt
Case Report Form Completion Instructions
Type
Collection Variable
Tabulation Target
Mapping Instructions
Controlled Terminology CodeList Name
Permissible Values
Pre-Populated Value
2
What was the category of the criterion?
Criterion Type
Record whether the criterion exception was Inclusion or Exclusion.
Text
IECAT
IECAT
3
What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?
Exception Criterion Identifier
If the subject was not eligible, record the identifying code for each criterion that was an exception.
Text
IETESTCD
IETESTCD
This is an example SDTM dataset that represents data collected on a protocol inclusion/exclusion CRF. The IECAT column uses the controlled terminology (EXCLUSION or INCLUSION). IETEST and IETESTCD are defined in the TI domain. The applicant assigned a number to each criteria from the study protocol using the permissible variable IESPID (Applicant-defined Identifier).
Rows 1-2:
Show data for a subject with 2 inclusion/exclusion exceptions.
Rows 3-4:
Show data for 2 other subjects, both of whom failed the same inclusion criterion.
