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Release Notes
Variable Name
Variable Label
Type
Controlled Terms, Codelist, or Format
Role
CDISC Notes
Core
STUDYID
Study Identifier
Char
Identifier
Unique identifier for a study.
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.
Content: For variable ESPARMCD, codelist PARMCDES is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
Content: For variable ESPARM, codelist PARMES is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist