| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format1 | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. Serves as a key to indicate that all datasets containing the same value of this variable are related by the purpose for which they were collected. | Req |
| DOMAIN | Domain Abbreviation | Char | PT | Identifier | Two-character abbreviation for the domain. | Req |
| SponsorApplicant-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 |
| IGDCMPID | Ingredient or Component Identifier | Char |
| Identifier | Identifier given to an ingredient, substance or component of a tobacco product (e.g., "Burley Tobacco", "Reconstituted Tobacco"). It originates in the IT or IN domain. See PT assumption 7a below for more information. | Perm |
| STOCONID | Applicant-defined Storage Conditions ID | Char |
| Identifier | Applicant-defined identifier for a set of storage conditions that are represented in the ES domain, where this identifier originates. See assumption 7b below for more information. (See also ES domain Specification and Assumptions for more information on the ES domain). | Perm |
| 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 | Reference ID | Char |
| Identifier | Internal or external identifier. In PT it is used to represent a smoking regimen, and serves as a link to the Device-In Use Properties (DU) domain, where a matching value of DUREFID indicated indicates parameters of the smoking regimen performed by the smoking machine. | Perm |
| SponsorApplicant-Defined Identifier | Char |
| Identifier | Sponsor Applicant-defined reference number. Can be used to identify an instance of an observation. Examples: a value pre-printed on a form; an identifier from the applicant's operational database. | Perm |
| PTTESTCD | 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 | Test or Examination Name | Char | (TESTPTPTTEST) | 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 |
| PTTSTDTL | Test Detail | Char |
| Record Qualifier | Further description of the test performed in producing the PT result (e.g., "DRY WEIGHT BASIS" in HPHC testing or stability testing). | Perm |
| PTCAT | Category of Test | Char | CATPT | Grouping Qualifier | Used to define a category of related records by purpose. Examples: "HPHC TESTING", "STABILITY STUDYTESTING", "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 of Test | Char | * |
| Grouping Qualifier | A further categorization of a test category. Examples: "HPHC" (for constituents designated as HPHCs under PTCAT=HPHC TESTING), "OTHER" (for constituents like tar, which are categorized under PTCAT=HPHC TESTING but that are not formally designated HPHCs). | 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 |
| | 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 Path | 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 should be referred to in this variable. | Perm | Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-185 |
|---|
|
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| 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/matrix used for a measurement. Examples: "TOBACCO", "E-LIQUID", "SMOKE", "VAPORAEROSOL". | 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. If lab methodology is too complex for this single variable, and supplemental lab documentation is instead submitted, a file name or path to such documentation should be included in the PTXFN variable instead. | 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 |
| PTREPNUM | Repetition Number | Num |
| Record Qualifier | The instance number of a test that is repeated within a given time frame for the same test performed. The level of granularity can vary (e.g., within a time point). Example: multiple measurements of tobacco product testing for a specific test. | 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| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-343 |
|---|
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| 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. Used when I sample is collected over a period of time, and the length of time is deemed significant to the test or the interpretation if its result. | 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 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 |