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ie.xpt, Inclusion/Exclusion Criteria Not Met — Findings. One record per inclusion/exclusion criterion not met per subject, Tabulation.

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

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharIEIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.Req
IESEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
IESPIDApplicant-Defined IdentifierChar
IdentifierApplicant-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Inclusion or Exclusion criteria number from CRF.Perm
IETESTCDInclusion/Exclusion Criterion Short NameChar
TopicShort 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
IETESTInclusion/Exclusion CriterionChar
Synonym QualifierVerbatim 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
IECATInclusion/Exclusion CategoryChar(IECAT)Grouping QualifierUsed to define a category of related records across subjects.Req
IESCATInclusion/Exclusion SubcategoryChar
Grouping QualifierA 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
IEORRESI/E Criterion Original ResultChar(NY)Result QualifierOriginal response to Inclusion/Exclusion Criterion question, i.e., whether the inclusion or exclusion criterion was met.Req
IESTRESCI/E Criterion Result in Std FormatChar(NY)Result QualifierResponse to Inclusion/Exclusion criterion result in standard format.Req
VISITNUMVisit NumberNum
Timing
  1. An assigned numeric identifier that aligns to the chronological order of an encounter.
  2. Numeric version of VISIT, used for sorting.
Perm
VISITVisit NameChar
Timing
  1. The label for a protocol-defined encounter.
  2. May be used in addition to VISITNUM and/or VISITDY.
Perm
VISITDYPlanned Study Day of VisitNum
TimingPlanned study day of the visit based upon RFSTDTC in Demographics.Perm
TAETORDPlanned Order of Element within ArmNum
TimingNumber that gives the planned order of the Element within the Arm for the Element in which the assessment was made.Perm
EPOCHEpochChar(EPOCH)TimingEpoch associated with the observation date/time of the inclusion/exclusion finding.Perm
IEDTCDate/Time of CollectionCharISO 8601 datetime or intervalTimingCollection date and time of the inclusion/exclusion criterion represented in ISO 8601 character format.Perm
IEDYStudy Day of CollectionNum
Timing
  1. Study day of collection of the inclusion/exclusion exceptions, measured as integer days.
  2. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission.
Perm

Assumptions

  1. The intent of the domain model is to collect responses to only those criteria that the subject did not meet, and not the responses to all criteria. The complete list of Inclusion/Exclusion criteria can be found in the Trial Inclusion/Exclusion Criteria (TI) dataset.
  2. This domain should be used to document the exceptions to inclusion or exclusion criteria at the time that eligibility for study entry is determined (e.g., at the end of a run-in period or immediately before randomization). This domain should not be used to collect protocol deviations/violations incurred during the course of the study, typically after randomization or start of study medication.
  3. IETEST is to be used only for the verbatim description of the inclusion or exclusion criteria. If the text is no more than 200 characters, it goes in IETEST; if the text is more than 200 characters, put meaningful text in IETEST and describe the full text in the study metadata.
  4. Additional findings qualifiers: The following Qualifiers would generally not be used in IE: --MODIFY, --POS, --BODSYS, --ORRESU, --ORNRLO, --ORNRHI, --STRESN, --STRESU, --STNRLO, --STNRHI, --STNRC, --NRIND, --RESCAT, --XFN, --NAM, --LOINC, --SPEC, --SPCCND, --LOC, --METHOD, --BLFL, --LOBXFL, --FAST, --DRVFL, --TOX, --TOXGR, --SEV, --STAT.

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