SDTM.IE

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	IE	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	IE	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	IE	USUBJID	Unique Subject Identifier	Char		Identifier	Req	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4	IE	IESEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	IE	IESPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Inclusion or Exclusion criteria number from CRF.
6	IE	IETESTCD	Inclusion/Exclusion Criterion Short Name	Char		Topic	Req	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".
7	IE	IETEST	Inclusion/Exclusion Criterion	Char		Synonym Qualifier	Req	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.
8	IE	IECAT	Inclusion/Exclusion Category	Char	C66797	Grouping Qualifier	Req	Used to define a category of related records across subjects.
9	IE	IESCAT	Inclusion/Exclusion Subcategory	Char		Grouping Qualifier	Perm	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".
10	IE	IEORRES	I/E Criterion Original Result	Char	C66742	Result Qualifier	Req	Original response to Inclusion/Exclusion Criterion question, i.e., whether the inclusion or exclusion criterion was met.
11	IE	IESTRESC	I/E Criterion Result in Std Format	Char	C66742	Result Qualifier	Req	Response to Inclusion/Exclusion criterion result in standard format.
12	IE	VISITNUM	Visit Number	Num		Timing	Perm	1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
13	IE	VISIT	Visit Name	Char		Timing	Perm	1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
14	IE	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
15	IE	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Number that gives the planned order of the Element within the Arm for the Element in which the assessment was made.
16	IE	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the observation date/time of the inclusion/exclusion finding.
17	IE	IEDTC	Date/Time of Collection	Char	ISO 8601	Timing	Perm	Collection date and time of the inclusion/exclusion criterion represented in ISO 8601 character format.
18	IE	IEDY	Study Day of Collection	Num		Timing	Perm	1. Study day of collection of the inclusion/exclusion exceptions, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission.