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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 AbbreviationCharSCIdentifierTwo-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
SCSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
SCGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a subject.Perm
SCSPIDApplicant-Defined IdentifierChar
IdentifierApplicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database.Perm
SCTESTCDSubject Characteristic Short NameChar(SCTESTCD)TopicShort name of the measurement, test, or examination described in SCTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in SCTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). SCTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "MARISTAT", "NATORIG".Req
SCTESTSubject CharacteristicChar(SCTEST)Synonym QualifierVerbatim name of the test or examination used to obtain the measurement or finding. The value in SCTEST cannot be longer than 40 characters. Examples: "Marital Status", "National Origin".Req
SCCATCategory for Subject CharacteristicChar
Grouping QualifierUsed to define a category of related records.Perm
SCSCATSubcategory for Subject CharacteristicChar
Grouping QualifierA further categorization of the subject characteristic.Perm
SCORRESResult or Finding in Original UnitsChar
Result QualifierResult of the subject characteristic as originally received or collected.Exp
SCORRESUOriginal UnitsChar(UNIT)Variable QualifierOriginal unit in which the data were collected. The unit for SCORRES.Perm
SCSTRESCCharacter Result/Finding in Std FormatChar
Result QualifierContains the result value for all findings copied or derived from SCORRES, in a standard format or standard units. SCSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in SCSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in SCORRES, and these results effectively have the same meaning, they could be represented in standard format in SCSTRESC as "NEGATIVE".Exp
SCSTRESNNumeric Result/Finding in Standard UnitsNum
Result QualifierUsed for continuous or numeric results or findings in standard format; copied in numeric format from SCSTRESC. SCSTRESN should store all numeric test results or findings.Perm
SCSTRESUStandard UnitsChar(UNIT)Variable QualifierStandardized unit used for SCSTRESC or SCSTRESN.Perm
SCSTATCompletion StatusChar(ND)Record QualifierUsed to indicate that the measurement was not done. Should be null if a result exists in SCORRES.Perm
SCREASNDReason Not PerformedChar
Record QualifierDescribes why the observation has no result. Example: "Subject refused". Used in conjunction with SCSTAT when value is "NOT DONE".Perm
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.Perm
EPOCHEpochChar(EPOCH)TimingEpoch associated with the start date/time at which the assessment was made.Perm
SCDTCDate/Time of CollectionCharISO 8601 datetime or intervalTimingCollection date and time of the subject characteristic represented in ISO 8601 character format.Perm
SCDYStudy Day of ExaminationNum
TimingStudy day of collection, measured as integer days. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics.Perm

Assumptions

  1. The structure of subject characteristics is based on the Findings general observation class and is an extension of the demographics data, including socioeconomic or other broad characteristics. The structure for demographic data is fixed and includes date of birth, age, sex, race, ethnicity, and country. Subject characteristics may be collected periodically over time. Some examples of subject characteristics include education level, marital status, and national origin.
  2. Any Identifiers, Timing variables, or Findings general observation class qualifiers may be added to the SC domain, but the following qualifiers would generally not be used in SC: --MODIFY, --POS, --BODSYS, --ORNRLO, --ORNRHI, --STNRLO, --STNRHI, --STNRC, --NRIND, --RESCAT, --XFN, --NAM, --LOINC, --SPEC, --SPCCND, --BLFL, --LOBXFL, --FAST, --DRVFL, --TOX, --TOXGR, --SEV.

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