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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 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 | PT | Identifier | Two-character abbreviation for the domain. | Req |
| SPTOBID | Sponsor-Defined Tobacco Product ID | Char | Identifier | Identifier 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 | |
| PTSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req | |
| PTGRPID | Group ID | Char | Identifier | Used to tie together a block of related records in a single domain for a subject. | Perm | |
| PTREFID | Sample ID | Char | Identifier | Internal or external sample identifier. Example: Batch number or lot number of the product being tested. | Perm | |
| PTSPID | Sponsor-Defined Identifier | Char | Identifier | Sponsor-defined reference number. | Perm | |
| PTTESTCD | Lab Test or Examination Short Name. | Char | (TESTCDPT) | Topic | Short 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 |
| PTTEST | Lab Test or Examination Name | Char | (TESTPT) | Synonym Qualifier | Verbatim 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 |
| PTCAT | Category for Lab Test | Char | (CATPT) | Grouping Qualifier | Used 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 a required variable in the PT domain to differentiate and group the records by purpose. | Req |
| PTSCAT | Subcategory for Lab Test | Char | * | Grouping Qualifier | A further categorization of a test category. Examples: "TEST PRODUCT", "PREDICATE PRODUCT". | Perm |
| PTORRES | Result or Finding in Original Units | Char | Result Qualifier | Result of the measurement or finding as originally received or collected. | Exp | |
| PTORRESU | Original Units | Char | (UNIT) | Variable Qualifier | Original units in which the data were collected. The unit for PTORRES. Example: "mg/mL". | Exp |
| PTLLOD | Lower Limit of Detection | Char | Variable Qualifier | The lowest threshold (as originally received or collected) for reliably detecting the presence or absence of substance measured by a specific test. The value for the field will be as described in documentation from the instrument or lab vendor. | Perm | |
| PTSTRESC | Character Result/Finding in Std Format | Char | Result Qualifier | Contains 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 | |
| PTSTRESN | Numeric Result/Finding in Standard Units | Num | Result Qualifier | Used 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 | |
| PTSTRESU | Standard Units | Char | (UNIT) | Variable Qualifier | Standardized unit used for PTSTRESC or PTSTRESN. | Exp |
| PTSTAT | Completion Status | Char | (ND) | Record Qualifier | Used to indicate exam not done. Should be null if a result exists in PTORRES. | Perm |
| PTREASND | Reason Test Not Done | Char | Record Qualifier | Describes 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 | |
| PTXFN | External File Name | Char | Record Qualifier | The filename and/or path to external data not stored in the same format and possibly not the same location as the other data for a study. For example, when submitting lab methodology as a separate document, the name of the document or path to the file in the folder structure in the submission. | ||
| PTNAM | Vendor Name | Char | Record Qualifier | The name or identifier of the laboratory that performed the test. | Perm | |
| PTSPEC | Specimen Material Type | Char | (SPECPT) | Record Qualifier | Defines the type of sample used for a measurement. Examples: "TOBACCO", "E-LIQUID", "SMOKE", "VAPOR". | Exp |
| PTSPCCND | Specimen Condition | Char | (SPCCNDPT) | Record Qualifier | The physical state or quality of a sample for an assessment. Examples: "AS-IS", "DRY WEIGHT BASIS". | Perm |
| PTMETHOD | Method of Test or Examination | Char | (METHOD) | Record Qualifier | Method used to arrive at the result of the test or examination. Not for representing smoking regimens or sample storage conditions. | Perm |
| PTBLFL | Baseline Flag | Char | (NY) | Record Qualifier | Indicator 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 |
| PTDRVFL | Derived Flag | Char | (NY) | Record Qualifier | Used 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 |
| PTLLOQ | Lower Limit of Quantitation | Num | Variable Qualifier | The lowest threshold for reliably quantifying the amount of substance measured by a specific test, in standardized units. | Perm | |
| PTULOQ | Upper Limit of Quantitation | Num | Variable Qualifier | The highest threshold for reliably detecting the result of a specific test in standardized units. | Perm | |
| PTDTC | Date/Time of Sample Testing | Char | ISO 8601 datetime or interval | Timing | Date/time of sample testing represented in ISO 8601 character format. | Exp |
| PTENDTC | End Date/Time of Sample Collection | Char | ISO 8601 datetime or interval | Timing | End date/time of sample collection represented in ISO 8601 character format. | Perm |
| PTTPT | Planned Time Point Name | Char | Timing |
| Perm | |
| PTTPTNUM | Planned Time Point Number | Num | Timing | Numerical version of PTTPT to aid in sorting. | Perm | |
| PTELTM | Planned Elapsed Time from Time Point Ref | Char | ISO 8601 duration | Timing | Planned 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 |
| PTTPTREF | Time Point Reference | Char | Timing | Name of the fixed reference point referred to by PTELTM, PTTPTNUM, and PTTPT. Example: "DATE OF MANUFACTURE". | Perm | |
| PTRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 datetime or interval | Timing | Date/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 TESTCDPT is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
- Content: For variable PTTEST, csodelist TESTPT is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
- Content: For variable PTCAT, csodelist CATPT is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
- Content: For variable PTLLOD, it is either invalid in the Findings class domain or not a recognized domain-specific variable
- Content: For variable PTXFN, non-ASCII characters (highlighted text in table), found in CDISC Notes; offending characters list: [ ]
- Content: For variable PTXFN, a value is missing in Core
- Content: For variable PTSPEC, csodelist SPECPT is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
- Content: For variable PTSPCCND, csodelist SPCCNDPT is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
- Content: For variable PTDTC, ISO 8601 datetime or interval is a not a recognized content for Controlled Terms, Codelist or Format1
- Content: For variable PTENDTC, ISO 8601 datetime or interval is a not a recognized content for Controlled Terms, Codelist or Format1
- Content: For variable PTELTM, ISO 8601 duration is a not a recognized content for Controlled Terms, Codelist or Format1
- Content: For variable PTRFTDTC, ISO 8601 datetime or interval is a not a recognized content for Controlled Terms, Codelist or Format1
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