The CDASHIG IE domain is recommended for collecting only inclusion/exclusion exceptions, in other words, those criteria that are "not met"; these are the data that are required to be in the SDTMIG IE domain. The CDASHIG IE domain is used to collect failures on or exceptions to the inclusion/exclusion criteria during the screening process before a subject is enrolled in a study. It is not intended to collect protocol deviations or violations that occur after enrollment; protocol deviations are collected using the DV domain.
For additional information about this domain, please see the CDASHIG.
The design of the IE domain CRF is aligned with the simplified method described in the CDASHIG and is intended for collecting only the inclusion/exclusion exceptions (i.e., criteria not met). Three duplicate rows are shown in the visualization to demonstrate the repeating nature of this section; however, sites would only add as many lines as needed.
When EDC system functionality is possible, the Exception Criterion Identifier (IETESTCD) values should dynamically display depending on the site’s response to the question What was the category of the criterion? (IECAT). For example, if Inclusion was selected only values Inclusion 1, Inclusion 2, and Inclusion 3 would be available for selection. If this type of EDC system functionality is not possible, the IECAT variable may be removed from the CRF and this value would be derived in SDTM.
The IETESTCD values shown are examples only and would be expected to be updated with each organization’s numbering scheme and aligned with the protocol.