SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1
Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting.
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
TC
Identifier
Two-character abbreviation for the domain.
Req
STOCONID
Char
Identifier
Sponsor-defined identifier for representing a set of storage conditions. STOCONID should be populated with an intuitive name based on a description of the storage conditions (e.g., "E-Liquid Standard Long Term Condition). It must be unique for each unique set of storage conditions as defined by the specific values of the condition's TOPARMCD-TOVAL pairs.
Req
ESSEQ
Sequence Number
Num
Identifier
Sequence number given to ensure uniqueness within a parameter within a tobacco product (SPTOBID) within the dataset.
Req
ESPARMCD
Tobacco Product ID Element Short Name
Char
PARMCDTO
Topic
Short name of the identifier or descriptor being described. Examples: "MANUF", "TRADENAM", "CIRCUMF".
Req
ESPARM
Tobacco Product ID Element Name
Char
PARMTO
Synonym Qualifier
Name of the identifying parameter or descriptor being described. Examples: "Manufacturer", "Trade Name", "Circumference".
Req
ESVAL
Tobacco Product ID Element Value
Char
*
Result Qualifier
Value for the parameter in TOPARMCD/TOPARM for the product identified by SPTOBID.
Req
ESVALU
Tobacco Product ID Element Value Unit
Char
UNIT
Result Qualifier
Unit for the value in TOVAL. Will be blank for unitless identifying descriptors (e.g., "Trade Name"). Must be used where applicable (e.g., "Circumference").
Content: For variable STOCONID, a value is missing in Variable Label
Content: For variable ESPARMCD, PARMCDTO is a not a recognized content for Controlled Terms, Codelist or Format1
Content: For variable ESPARM, PARMTO 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.