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Description

Inclusion/Exclusion Criteria Not Met (IE) is a Findings domain used for those criteria that cause the subject to be in violation of the inclusion/exclusion criteria. The 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.

The recommendation is that individuals involved in data collection be given an entry criteria worksheet to be used for each subject, to record the results of eligibility review. This worksheet should be considered a source document, used in monitoring activities and maintained with the subject’s files. The worksheet should identify each criterion using a unique identifier, which can be easily recorded on the CRF if a subject does not meet that criterion. If criteria lists are numbered the same for both inclusion and exclusion criteria (e.g., inclusion 001-100, exclusion 001-100), then this identifier could include a means of identifying the type of criterion (e.g., I001-I100, E001-E100). Alternatively, the criteria could be collected in 2 separate sections on the CRF labeled "Inclusion" and "Exclusion," and the output records could include the values of Inclusion or Exclusion on each record. These are only examples; an organization’s numbering scheme may be different, but some method that captures both the Inclusion or Exclusion category and the unique criterion identifier should be used.

The recommended collection method has been simplified to require recording of a single "Y/N" value in the IEYN variable to indicate whether the subject met all of the criteria. If any criterion is not met, then this is recorded in the CRF. The result value for each unmet criterion may then be derived in the tabulation IE domain from the collection of the specific criterion that was not met. In other words, if the collected criterion is an inclusion criterion that was not met, the value of "N" can be derived into IEORRES and IESTRESC for that record in the tabulation IE domain. If it is an exclusion criterion, then "Y" can be derived into IEORRES and IESTRESC to indicate that the subject met the conditions for that exclusion record in IE.

The rationale for the recommended collection method is that what is being collected in the IE CRF is aligned with the data that would be in the tabulation IE domain.

This design allows criteria to change over the life of a study or project. If inclusion/exclusion criteria are amended, then each complete set of criteria will be included in the TI domain. TIVERS is used to distinguish between versions of eligibility criteria.

Use of uniquely numbered entry criteria are recommended within a study to effectively manage protocol changes and to facilitate the collection and submission of IE data. The Inclusion/Exclusion worksheet may need to be updated and renumbered/relettered whenever a protocol amendment changes 1 or more criteria. For example, if new versions of a criterion have not been given new numbers, separate values of IETESTCD might be created by appending letters (e.g., INCL003A, INCL003B). A field could be added to the CRF to capture the version number of the criteria being used; this can be mapped to the tabulation variable TI.TIVERS. This enables the retrieval of the full text of the criterion from the code used on the CRF.

Alternatively, an implementer may choose to include the full text of each criterion (IETEST) with a result field (IEORRES) in the CRF and request the site to record explicitly the "Y" or the "N" for each criterion, but only the recommended, simplified method is presented in the IE example CRF.

Specification

Assumptions