| 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 | ES | Identifier | Two-character abbreviation for the domain. | Req |
| STOCONID | Applicant-defined Storage Conditions ID | Char |
| Identifier | Applicant-defined identifier for representing a set of storage conditions. Can also be used in the PT domain where storage conditions of the product being tested are applicable (e.g., stability studies). STOCONID should be populated with an intuitive name based on a description of the storage conditions. If a published standard set of conditions is used, the value should represent that (e.g., "E-Liquid Standard Long Term Conditions"). If the study applicant creates their own set of storage conditions, or modifies a standard set, the value should reflect that (e.g., "Modified E-Liquid Standard Long Term Conditions"). It must be unique for each unique set of storage conditions as defined by the specific values of ESPARMCD-ESVAL pairs. | Req |
| ESSEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness within a parameter within the set of storage conditions represent by STOCONID within the dataset. | Req |
| ESPARMCD | Storage Conditions Element Short Name | CharPARMCDES | | Topic | Short name of the identifier or descriptor being described. Examples: "TEMP", "HUMID". | Req |
| ESPARM | Tobacco Product ID Element Name | CharPARMES | (ESPARM) | Synonym Qualifier | Name of the identifying parameter or descriptor being described. Examples: "Temperature", "Humidity". | Req |
| ESVAL | Tobacco Product ID Element Value | Char* |
| Result Qualifier | Value for the parameter in ESPARMCD/ESPARM for a condition within a set of conditions identified by STOCONID. | Req |
| ESVALU | Tobacco Product ID Element Value Unit | Char | (UNIT) | Result Qualifier | Unit for the value in ESVAL. Must be used when value for the parameter has units. | Perm |