SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1
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Release Notes
Variable Name
Variable Label
Type
Controlled Terms, Codelist or Format1
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
Sponsor-defined Storage Conditions ID
Char
Identifier
Sponsor-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 sponsor 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.
Req
ESPARMCD
Storage Conditions Element Short Name
Char
PARMCDES
Topic
Short name of the identifier or descriptor being described. Examples: "TEMP", "HUMID".
Req
ESPARM
Tobacco Product ID Element Name
Char
PARMES
Synonym Qualifier
Name of the identifying parameter or descriptor being described. Examples: "Temperature", "Humidity".
Req
ESVAL
Tobacco Product ID Element Value
Char
*
Result Qualifier
Value for the parameter in ESPARMCD/ESPARM for a condition within a set of conditions identified by STOCONID.
Req
ESVALU
Tobacco Product ID Element Value Unit
Char
UNIT
Result Qualifier
Unit for the value in ESVAL. Must be used when value for the parameter has units.
Content: For variable ESPARMCD, PARMCDES is a not a recognized content for Controlled Terms, Codelist or Format1
Content: For variable ESPARM, PARMES is a not a recognized content for Controlled Terms, Codelist or Format1
Content: For variable ESVALU, UNIT is a not a recognized content for Controlled Terms, Codelist or Format1
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.