| 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 Identifier | Char |
| Identifier | Identifier used to uniquely identify a tobacco product across all studies for all applications or submissions involving the product. | 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 | (PTTESTCD) | 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 | (PTTEST) | Synonym Qualifier | Verbatim name of the test or examination used to obtain the measurement or finding. Note any test normally performed by a clinical laboratory is considered a lab test. The value in PTTEST cannot be longer than 40 characters. Examples: "Ammonia", "Benzene". | Req |
| PTCAT | Category for Lab Test | Char | * | 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 required for tobacco product testing to differentiate and group the records. | Req |
| PTSCAT | Subcategory for Lab Test | Char | * | Grouping Qualifier | A further categorization of a test category. | 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 |
| PTORNRLO | Reference Range Lower Limit in Orig Unit | Char |
| Variable Qualifier | Lower end of reference range for continuous measurement in original units. Should be populated only for continuous results. | Perm |
| PTORNRHI | Reference Range Upper Limit in Orig Unit | Char |
| Variable Qualifier | Upper end of reference range for continuous measurement in original units. Should be populated only for continuous results. | Perm |
| PTSTRESC | Character Result/Finding in Std Format | Char | (PTSTRESC) | 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 |
| PTSTNRLO | Reference Range Lower Limit-Std Units | Num |
| Variable Qualifier | Lower end of reference range for continuous measurements for PTSTRESC/PTSTRESN in standardized units. Should be populated only for continuous results. | Perm |
| PTSTNRHI | Reference Range Upper Limit-Std Units | Num |
| Variable Qualifier | Upper end of reference range for continuous measurements in standardized units. Should be populated only for continuous results. | Perm |
| PTSTNRC | Reference Range for Char Rslt-Std Units | Char |
| Variable Qualifier | For normal range values that are character in ordinal scale or if categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE"). | Perm |
| PTSTREFC | Reference Result in Standard Format | Char |
| Variable Qualifier | Reference value for the result or finding copied or derived from PTORREF in a standard format. | Perm |
| PTNRIND | Reference Range Indicator | Char | (NRIND) | Variable Qualifier | - 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".
- 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 |
| 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 "SPECIMEN SAMPLE LOST". Used in conjunction with PTSTAT when value is "NOT DONE". | Perm |
| PTNAM | Vendor Name | Char |
| Record Qualifier | The name or identifier of the laboratory that performed the test. | Perm |
| PTMATRIX | Sample Matrix | Char | (MATRIX) | Record Qualifier | Defines the type of specimen sample used for a measurement. Examples: "SERUMTOBACCO", "PLASMAE-LIQUID", "URINESMOKE", "DNA", "RNAVAPOR". | Exp |
| PTMTXCND | Matrix Condition | Char | (MATCOND) | Record Qualifier | Free or standardized text describing the condition of the specimensample, e.g., "DRY WEIGHT BASIS", "AS-IS". | Perm |
| PTMETHOD | Method of Test or Examination | Char | (METHOD) | Record Qualifier | Method of the test or examination. Examples: "". | Perm |
| PTLOBXFL | Last Observation Before Exposure Flag | Char | (NY) | Record Qualifier | Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null. | Exp |
| 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 |
| PTFAST | Fasting Status | Char | (NY) | Record Qualifier | Indicator used to identify fasting status such as "Y", "N", "U", or null if not relevant. | 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 |
| PTDTC | Date/Time of Sample Testing | Char | ISO 8601 | Timing | Date/time of sample testing represented in ISO 8601 character format. | Exp |
| PTENDTC | End Date/Time of Sample Collection | Char | ISO 8601 | Timing | End date/time of sample collection represented in ISO 8601 character format. | Perm |
| PTTPT | Planned Time Point Name | Char |
| Timing | - Text description of time when sample should be tested.
- 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 |
| 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 | 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: "PLACED IN STORAGE" | Perm |
| PTRFTDTC | Date/Time of Reference Time Point | Char | ISO 8601 | Timing | Date/time of the reference time point, PTTPTREF. | Perm |