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
PD
Identifier
Two-character abbreviation for the domain.
Req
SPTOBID
Sponsor-Defined Tobacco Product ID
Char
Identifier
Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. In product description studies (i.e., where there are no human subjects) it is the top-level identifier.
Req
PDSEQ
Sequence Number
Num
Identifier
Sequence number given to ensure uniqueness within a design parameter within a tobacco product (SPTOBID) within the dataset.
Req
PDPARMCD
Design Parameter Element Short Name
Char
(PARMCDPD)
Topic
Short name of the parameter being described. Examples: "TOCUTSIZ", "BATCAPC".
Req
PDPARM
Design Parameter Element Name
Char
(PARMPD)
Synonym Qualifier
Name of the parameter being described. Examples: "Tobacco Cut Size", "Battery Capacity".
Req
PDVALTRG
Design Parameter Element Target Value
Char
*
Result Qualifier
Target value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID.
Req
PDVALMIN
Design Parameter Element Minimum Value
Char
Result Qualifier
Minimum allowable value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID.
Exp
PDVALMAX
Design Parameter Element Maximum Value
Char
Result Qualifier
Maximum allowable value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID.
Exp
PDVALU
Design Parameter Element Value Unit
Char
(UNIT)
Result Qualifier
The single unit for the values in PDVALTRG, PDVALMIN and PDVALMAX. Will be blank for unitless parameters (e.g., "Number of Heating Elements"). Must be used where applicable (e.g., "Circumference").
Content: For variable PDPARMCD, codelist PARMCDPD is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
Content: For variable PDPARM, codelist PARMPD is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.