1. The recommendation is for only those records for criteria that are not met to be collected on the IE CRF.
  2. The complete list of inclusion/exclusion criteria and the version number of each of the criteria are provided in the SDTMIG TI dataset. The IETEST and IETESTCD values used to collect data on the IE CRF should match the values in the TI dataset.
  3. Categories IECAT and IESCAT
    1. The tabulation variable IECAT must be populated with INCLUSION or EXCLUSION. This criterion category may be collected on the CRF in a checkbox format using the collection field IECAT, or it may be included as part of the criterion identification and populated when the tabulation datasets are created.
    2. IESCAT may be used by the applicant to further categorize the exception criteria within the larger categories of Inclusion or Exclusion (e.g., Major, Minor).
    3. These categories may be collected on the CRF, or they may be used as titles on the CRF and hidden/defaulted in the operational system. If these categories are not collected on the CRF or created in the operational data management system, they are added when the tabulation datasets are created.
  4. There should be a unique IETESTCD for each unique criterion text in IETEST, and these values must match the values in the TI domain.
  5. It may be useful to collect the protocol version under which a subject was screened.
  6. The collection date (IEDAT) is the date that the IE data were recorded for the study, and not the actual date the exception occurred. The visit date (VISDAT) may be used, instead, to populate the tabulation IEDTC variable.
  7. The result (IEORRES)—"Y" or "N"—for each tabulation IETESTCD is derived or inferred from the collection of the specific criterion not met. IEORRES must be populated in the tabulation IE domain because it is a Required variable. Applicants will populate this in the operational data management system or in the creation of the tabulation datasets. When an inclusion criterion is not met, the tabulation variable IEORRES is populated with "N"; when an exclusion criterion is not met, IEORRES is populated with "Y".