Versions Compared

Old Version 4

changes.mady.by.user Jon Neville

Saved on

compared with

New Version Current

changes.mady.by.user Lorraine Sobson

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
  1. ES is a study reference dataset that provides a consistent identifier–the Sponsoridentifier—the Applicant-defined Storage Conditions ID (STOCONID)–for a —for the set of conditions under which a product was stored during testing. The dataset contains these storage condition parameters (e.g., temperature, humidity, etc) and merges those characteristics on this single identifier.
    1. STOCONID is sponsorapplicant-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 any dataset the Tobacco Product Testing (PT) domain, where the storage conditions it identifies are applicable to observations contained in that dataset domain (e.g, it can be used in the PT domain 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 . Examples of storage condition parameters include (e.g., temperature, humidity, percent oxygen, climate zone, etc).
  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.g., the PT domain).