SDTM IE specification

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes

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	Sponsor-Defined Identifier	Char		Identifier	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.	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 number. Numeric version of VISIT, used for sorting.	Perm
VISIT	Visit Name	Char		Timing	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	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 applicant-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission.	Perm

Metadata Checks Findings

Metadata Check User Macros FAQ

Structure: Mismatch column 4 label: Controlled Terms, Codelist or Format1 (seen) vs. Controlled Terms, Codelist, or Format (expected)
Notice: <strong>Checks for table content are suspended due to structrual issues reported above. Content checks will resume after all structural issues are resolved</strong>

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SDTM IE specification