Description

A study reference dataset that provides a consistent identifier (STOCONID) for the representation of a set of environmental conditions under which a test article is stored, and contains a list of those conditions.

es.xpt, Environmental Storage Conditions — Study Reference. One record per parameter code per defined set of storage conditions, Tabulation.


Specification

TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique 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
DOMAINDomain AbbreviationCharESIdentifierTwo-character abbreviation for the domain.Req
STOCONIDApplicant-defined Storage Conditions IDChar
IdentifierApplicant-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
ESSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness within a parameter within the set of storage conditions represent by STOCONID within the dataset.Req
ESPARMCDStorage Conditions Element Short NameChar

(ESPARMCD)

TopicShort name of the identifier or descriptor being described. Examples: "TEMP", "HUMID".Req
ESPARMTobacco Product ID Element NameChar(ESPARM)Synonym QualifierName of the identifying parameter or descriptor being described. Examples: "Temperature", "Humidity".Req
ESVALTobacco Product ID Element ValueChar
Result QualifierValue for the parameter in ESPARMCD/ESPARM for a condition within a set of conditions identified by STOCONID.Req
ESVALUTobacco Product ID Element Value UnitChar(UNIT)Result QualifierUnit for the value in ESVAL. Must be used when value for the parameter has units.Perm


Assumptions

  1. ES is a study reference dataset that provides a consistent identifier—the Applicant-defined Storage Conditions ID (STOCONID)—for the set of conditions under which a product was stored during testing. The dataset contains these storage condition parameters (e.g., temperature, humidity) and merges those characteristics on this single identifier.
    1. STOCONID is applicant-defined, but it must be unique with regard to the specific set of storage conditions contained in the ES dataset.
    2. STOCONID can also be used in the Tobacco Product Testing (PT) domain, where the storage conditions it identifies are applicable to observations contained in that domain (e.g, when representing the results of stability studies in the PT domain that were conducted under a set of storage conditions represented in ES).
  2. ESPARMCD/ESPARM are the parameters of the storage conditions (e.g., temperature, humidity, percent oxygen, climate zone).
  3. Timing and duration of storage would be determined in the context of the testing of stored samples from the timing variables used in the domain where the testing results are represented (i.e., the PT domain).

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