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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 within the submission.Req
DOMAINDomain AbbreviationCharDAIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierUnique subject identifier within the submission.Req
DASEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
DAGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a subject.Perm
DAREFIDReference IDChar
IdentifierInternal or external identifier such as label number.Perm
DASPIDApplicant-Defined IdentifierChar
IdentifierApplicant-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Examples: Line number on the Product Accountability page, product label code.Perm
DATESTCDShort Name of Accountability AssessmentChar(DATESTCD)TopicShort character value for DATEST used as a column name when converting a dataset from a vertical format to a horizontal format. The short value can be up to 8 characters and cannot begin with a number or contain characters other than letters, numbers, or underscores. Example: "DISPAMT", "RETAMT".Req
DATESTName of Accountability AssessmentChar(DATEST)Synonym QualifierVerbatim name, corresponding to the topic variable, of the test or examination used to obtain the product accountability assessment. The value in DATEST cannot be longer than 40 characters. Example: "Dispensed Amount", "Returned Amount".Req
DACATCategoryChar
Grouping QualifierUsed to define a category of topic-variable values (e.g., "STUDY PRODUCT)..Perm
DASCATSubcategoryChar
Grouping QualifierUsed to define a further categorization level for a group of related records.Perm
DAORRESResult or Finding in Original UnitsChar
Result QualifierResult of the Product Accountability assessment as originally received or collected.Exp
DAORRESUOriginal UnitsChar(UNIT)Variable QualifierUnit for DAORRES.Perm
DASTRESCResult or Finding in Standard FormatChar
Result QualifierContains the result value for all Product Accountability assessments, copied or derived from DAORRES in a standard format or in standard units. DASTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in DASTRESN.Exp
DASTRESNNumeric Result/Finding in Standard UnitsNum
Result QualifierUsed for continuous or numeric results or findings in standard format; copied in numeric format from DASTRESC. DASTRESN should store all numeric test results or findings.Perm
DASTRESUStandard UnitsChar(UNIT)Variable QualifierStandardized units used for DASTRESC and DASTRESN.Perm
DASTATCompletion StatusChar(ND)Record QualifierUsed to indicate that a product accountability assessment was not done. Should be null or have a value of "NOT DONE".Perm
DAREASNDReason Not DoneChar
Record QualifierReason not done. Used in conjunction with DASTAT 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.
Exp
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 of the observation, or the date/time of collection if start date/time is not collected.Perm
DADTCDate/Time of CollectionCharISO 8601 datetime or intervalTimingDate and time of the product accountability assessment represented in ISO 8601 character format.Exp
DADYStudy Day of Visit/Collection/ExamNum
Timing
  1. Study day of product accountability assessment, measured in integer days.
  2. Algorithm for calculations must be relative to the applicant-defined RFSTDTC in Demographics.
Perm

Assumptions

  1. One way an applicant may choose to differentiate different types of products, (e.g., study product, comparator product) is to use DACAT.
  2. DAREFID and DASPID are both available for capturing label information.
  3. Any Identifiers, Timing variables, or Findings general observation class qualifiers may be added to the DA domain, but the following Qualifiers would not generally be used in DA: --MODIFY, --POS, --BODSYS, --ORNRLO, --ORNRHI, --STNRLO, --STNRHI, --STNRC, --NRIND, --RESCAT, --XFN, --NAM, --LOINC, --SPEC, --SPCCND, --METHOD, --BLFL, --FAST, --DRVFL, --TOX, --TOXGR, --SEV.

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