- The intent of the domain model is to collect responses to only those criteria that the subject did not meet, and not the responses to all criteria. The complete list of Inclusion/Exclusion criteria can be found in the Trial Inclusion/Exclusion Criteria (TI) dataset described in Section 7.4.1, Trial Inclusion/Exclusion Criteria.
- This domain should be used to document the exceptions to inclusion or exclusion criteria at the time that eligibility for study entry is determined (e.g., at the end of a run-in period or immediately before randomization). This domain should not be used to collect protocol deviations/violations incurred during the course of the study, typically after randomization or start of study medication. See Section 6.2.4, Protocol Deviations, for the Protocol Deviations (DV) events domain model that is used to submit protocol deviations/violations.
- IETEST is to be used only for the verbatim description of the inclusion or exclusion criteria. If the text is no more than 200 characters, it goes in IETEST; if the text is more than 200 characters, put meaningful text in IETEST and describe the full text in the study metadata. See Section 4.5.3.1, Test Name (--TEST) Greater Than 40 Characters, for further information.
- Additional findings qualifiers: The following Qualifiers would generally not be used in IE: --MODIFY, --POS, --BODSYS, --ORRESU, --ORNRLO, --ORNRHI, --STRESN, --STRESU, --STNRLO, --STNRHI, --STNRC, --NRIND, --RESCAT, --XFN, --NAM, --LOINC, --SPEC, --SPCCND, --LOC, --METHOD, --BLFL, --LOBXFL, --FAST, --DRVFL, --TOX, --TOXGR, --SEV, --STAT.
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