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SDTMIG v3.3 Metadata Check for Domain Specification Table 1.3.1

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. <a href="https://wiki.cdisc.org/x/r37dAg" target="_blank">Release Notes</a>

Variable NameVariable LabelTypeControlled Terms, Codelist or Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharPTIdentifierTwo-character abbreviation for the domain.Req
SPTOBIDSponsor-Defined Tobacco Product IDChar
IdentifierIdentifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. In product description studies (i.e., where there are no human subjects) it is the top-level identifier.Req
PTSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
PTGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a subject.Perm
PTREFIDSample IDChar
IdentifierInternal or external sample identifier. Example: Batch number or lot number of the product being tested.Perm
PTSPIDSponsor-Defined IdentifierChar
IdentifierSponsor-defined reference number.Perm
PTTESTCDLab Test or Examination Short Name.Char(PTTESTCD)TopicShort name of the measurement or test described in PTTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PTTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PTTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "NH4", "BENZ".Req
PTTESTLab Test or Examination NameChar(PTTEST)Synonym QualifierVerbatim name of the test or examination used to obtain the measurement or finding. The value in PTTEST cannot be longer than 40 characters. Examples: "Ammonia", "Benzene".Req
PTCATCategory for Lab TestChar*Grouping QualifierUsed to define a category of related records by purpose. Examples: "HPHC TESTING", "STABILITY STUDY", "DESIGN PARAMETER TESTING". Note: given the vast amount of data types that will use this domain, PTCAT is required for tobacco product testing to differentiate and group the records.Req
PTSCATSubcategory for Lab TestChar*Grouping QualifierA further categorization of a test category. Examples: "TEST PRODUCT", "PREDICATE PRODUCT"Perm
PTORRESResult or Finding in Original UnitsChar
Result QualifierResult of the measurement or finding as originally received or collected.Exp
PTORRESUOriginal UnitsChar(UNIT)Variable QualifierOriginal units in which the data were collected. The unit for PTORRES. Example: "mg/mL".Exp
PTORNRLOReference Range Lower Limit in Orig UnitChar
Variable QualifierLower end of reference range for continuous measurement in original units. Should be populated only for continuous results.Perm
PTORNRHIReference Range Upper Limit in Orig UnitChar
Variable QualifierUpper end of reference range for continuous measurement in original units. Should be populated only for continuous results.Perm
PTSTRESCCharacter Result/Finding in Std FormatChar(PTSTRESC)Result QualifierContains the result value for all findings, copied or derived from PTORRES in a standard format or standard units. PTSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in PTSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in PTORRES and these results effectively have the same meaning, they could be represented in standard format in PTSTRESC as "NEGATIVE". For other examples, see general assumptions.Exp
PTSTRESNNumeric Result/Finding in Standard UnitsNum
Result QualifierUsed for continuous or numeric results or findings in standard format; copied in numeric format from PTSTRESC. PTSTRESN should store all numeric test results or findings.Exp
PTSTRESUStandard UnitsChar(UNIT)Variable QualifierStandardized unit used for PTSTRESC or PTSTRESN.Exp
PTSTNRLOReference Range Lower Limit-Std UnitsNum
Variable QualifierLower end of reference range for continuous measurements for PTSTRESC/PTSTRESN in standardized units. Should be populated only for continuous results.Perm
PTSTNRHIReference Range Upper Limit-Std UnitsNum
Variable QualifierUpper end of reference range for continuous measurements in standardized units. Should be populated only for continuous results.Perm
PTSTNRCReference Range for Char Rslt-Std UnitsChar
Variable QualifierFor normal range values that are character in ordinal scale or if categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE").Perm
PTSTREFCReference Result in Standard FormatChar
Variable QualifierReference value for the result or finding copied or derived from PTORREF in a standard format.Perm
PTNRINDReference Range IndicatorChar(NRIND)Variable Qualifier
  1. Indicates where the value falls with respect to reference range defined by PTORNRLO and PTORNRHI, PTSTNRLO and PTSTNRHI, or by PTSTNRC. Examples: "NORMAL", "ABNORMAL", "HIGH", "LOW".
  2. Sponsors should specify in the study metadata (Comments column in the Define-XML document) whether PTNRIND refers to the original or standard reference ranges and results.
Perm
PTSTATCompletion StatusChar(ND)Record QualifierUsed to indicate exam not done. Should be null if a result exists in PTORRES.Perm
PTREASNDReason Test Not DoneChar
Record QualifierDescribes why a measurement or test was not performed, e.g., "BROKEN EQUIPMENT", or "SAMPLE LOST". Used in conjunction with PTSTAT when value is "NOT DONE".Perm
PTNAMVendor NameChar
Record QualifierThe name or identifier of the laboratory that performed the test.Perm
PTMATRIXSample MatrixChar(MATRIX)Record QualifierDefines the type of sample used for a measurement. Examples: "TOBACCO", "E-LIQUID", "SMOKE", "VAPOR".Exp
PTMTXCNDMatrix ConditionChar(MATCOND)Record QualifierFree or standardized text describing the condition of the sample, e.g., "DRY WEIGHT BASIS", "AS-IS".Perm
PTMETHODMethod of Test or ExaminationChar(METHOD)Record QualifierMethod of the test or examination. Examples: "".Perm
PTBLFLBaseline FlagChar(NY)Record QualifierIndicator used to identify a baseline value. Should be "Y" or null. Note that PTBLFL is retained for backward compatibility. The authoritative baseline for statistical analysis is in an ADaM dataset.Perm
PTDRVFLDerived FlagChar(NY)Record QualifierUsed to indicate a derived record. The value should be "Y" or null. Records that represent the average of other records, or do not come from the CRF, or are not as originally received or collected are examples of records that might be derived for the submission datasets. If PTDRVFL = "Y", then PTORRES may be null, with PTSTRESC and (if numeric) PTSTRESN having the derived value.Perm
PTDTCDate/Time of Sample TestingCharISO 8601TimingDate/time of sample testing represented in ISO 8601 character format.Exp
PTENDTCEnd Date/Time of Sample CollectionCharISO 8601TimingEnd date/time of sample collection represented in ISO 8601 character format.Perm
PTTPTPlanned Time Point NameChar
Timing
  1. Text description of time when sample should be tested.
  2. This may be represented as an elapsed time relative to a fixed reference point, such as date of manufacture. See PTTPTNUM and PTTPTREF. Examples: "Week 12".
Perm
PTTPTNUMPlanned Time Point NumberNum
TimingNumerical version of PTTPT to aid in sorting.Perm
PTELTMPlanned Elapsed Time from Time Point RefCharISO 8601TimingPlanned elapsed time (in ISO 8601) relative to a planned fixed reference (PTTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date/time variable. Represented as ISO 8601 duration. Example: "PT60D" to represent the period of 60 days after the reference point indicated by PTTPTREF.Perm
PTTPTREFTime Point ReferenceChar
TimingName of the fixed reference point referred to by PTELTM, PTTPTNUM, and PTTPT. Example: "PLACED IN STORAGE".Perm
PTRFTDTCDate/Time of Reference Time PointCharISO 8601TimingDate/time of the reference time point, PTTPTREF.Perm

Metadata Checks Findings

SDTMIG v3.3 Metadata Check User Macros FAQ
  • Content: For variable SPTOBID, it is either invalid in the Findings class domain or not a recognized domain-specific variable
  • Content: For variable PTTESTCD, csodelist PTTESTCD is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
  • Content: For variable PTTEST, csodelist PTTEST is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
  • Content: For variable PTSCAT, CDISC Notes does not have an ending period
  • Content: For variable PTSTRESC, csodelist PTSTRESC is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
  • Content: For variable PTMATRIX, it is either invalid in the Findings class domain or not a recognized domain-specific variable
  • Content: For variable PTMATRIX, csodelist MATRIX is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
  • Content: For variable PTMTXCND, it is either invalid in the Findings class domain or not a recognized domain-specific variable
  • Content: For variable PTMTXCND, csodelist MATCOND is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
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