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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).

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showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-726

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.

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