| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format1 | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
| DOMAIN | Domain Abbreviation | Char | IE | Identifier | Two-character abbreviation for the domain. | Req |
| USUBJID | Unique Subject Identifier | Char |
| Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req |
| IESEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req |
| IESPID | SponsorApplicant-Defined Identifier | Char |
| Identifier | SponsorApplicant-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsorapplicant's operational database. Example: Inclusion or Exclusion criteria number from CRF. | Perm |
| IETESTCD | Inclusion/Exclusion Criterion Short Name | Char* |
| Topic | Short name of the criterion described in IETEST. The value in IETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). IETESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "IN01", "EX01". | Req |
| IETEST | Inclusion/Exclusion Criterion | Char |
| Synonym Qualifier | Verbatim description of the inclusion or exclusion criterion that was the exception for the subject within the study. IETEST cannot be longer than 200 characters. | Req |
| IECAT | Inclusion/Exclusion Category | Char | (IECAT) | Grouping Qualifier | Used to define a category of related records across subjects. | Req |
| IESCAT | Inclusion/Exclusion Subcategory | Char* |
| Grouping Qualifier | A further categorization of the exception criterion. Can be used to distinguish criteria for a sub-study or for to categorize as a major or minor exceptions. Examples: "MAJOR", "MINOR". | Perm |
| IEORRES | I/E Criterion Original Result | Char | (NY) | Result Qualifier | Original response to Inclusion/Exclusion Criterion question, i.e., whether the inclusion or exclusion criterion was met. | Req |
| IESTRESC | I/E Criterion Result in Std Format | Char | (NY) | Result Qualifier | Response to Inclusion/Exclusion criterion result in standard format. | Req |
| VISITNUM | Visit Number | Num |
| Timing | - Clinical encounter numberAn assigned numeric identifier that aligns to the chronological order of an encounter.
- Numeric version of VISIT, used for sorting.
| Perm |
| VISIT | Visit Name | Char |
| Timing | - ProtocolThe label for a protocol-defined description of clinical encounter.
- May be used in addition to VISITNUM and/or VISITDY.
| Perm |
| VISITDY | Planned Study Day of Visit | Num |
| Timing | Planned study day of the visit based upon RFSTDTC in Demographics. | Perm |
| TAETORD | Planned Order of Element within Arm | Num |
| Timing | Number that gives the planned order of the Element within the Arm for the Element in which the assessment was made. | Perm |
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the observation date/time of the inclusion/exclusion finding. | Perm |
| IEDTC | Date/Time of Collection | Char | ISO 8601 datetime or interval | Timing | Collection date and time of the inclusion/exclusion criterion represented in ISO 8601 character format. | Perm |
| IEDY | Study Day of Collection | Num |
| Timing | - Study day of collection of the inclusion/exclusion exceptions, measured as integer days.
- Algorithm for calculations must be relative to the sponsorapplicant-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission.
| Perm |