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.
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Assumptions
- 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.
- STOCONID is applicant-defined, but it must be unique with regard to the specific set of storage conditions contained in the ES dataset.
- 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).
- ESPARMCD/ESPARM are the parameters of the storage conditions (e.g., temperature, humidity, percent oxygen, climate zone).
- 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).
Overview
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