Versions Compared

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 identifier–the Sponsor-defined Storage Conditions ID (STOCONID) for –for a set of conditions under which a product was stored during testing. The dataset contains these storage condition parameters (temperature, humidity, etc) and merges those characteristics on this single identifier.
    1. STOCONID is sponsor-defined, but it must be unique with regard to the specific set of storage conditions contained in the ES dataset.
    2. STOCONID can be used in any dataset where there are records pertaining to the storage conditions it identifies are applicable to observations contained in that dataset (e.g, it can be used in the PT domain when representing the results of stability studies).