SDTMIG v3.3 Metadata Check for Domain Specification Table 1.3.1
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<a href="https://wiki.cdisc.org/x/r37dAg" target="_blank">Release Notes</a>
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
DO
Identifier
Two-character abbreviation for the domain.
Req
SPDEVID
Sponsor Device Identifier
Char
Identifier
Sponsor-defined identifier for the device.
It must be unique for each tracked unit of the device under study, and can be at whatever level of granularity the device should be identified (e.g., model or serial number, combination of identifiers).
Req
DOSEQ
Sequence Number
Num
Identifier
Sequence Number given to ensure uniqueness of device records within subject records within a domain.
May be any valid number. It should be unique within every subject/device combination.
Req
DOGRPID
Group ID
Char
Identifier
Used to tie together a block of related records in a single domain for a device.
Perm
DOREFID
Reference ID
Char
Identifier
Internal or external identifier.
This could be a scan code or equivalent.
Perm
DOSPID
Sponsor-Defined Identifier
Char
Identifier
Sponsor-defined reference number.
Perm
DOTESTCD
Device Property Short Name
Char
(DOTESTCD)
Topic
Short name of the measurement, test, or examination described in DOTEST.
It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in DOTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). DOTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "SHLFLIFE", "INDC", "COMPOS".
Req
DOTEST
Device Property Test Name
Char
(DOTEST)
Synonym Qualifier
Verbatim name of the test or examination used to obtain the measurement or finding.
The value in DOTEST cannot be longer than 40 characters. Examples: "Shelf Life", "Indication for use", "Composition" (of device).
Req
DOCAT
Category for Device In-Use
Char
*
Grouping Qualifier
Defines a category of related records.
For example, it can be used to define the type of property being defined, such as "DIMENSIONS" versus "MATERIAL".
Perm
DOSCAT
Subcategory for Device In-Use
Char
*
Grouping Qualifier
A further categorization of a measurement or examination.
For example, if DOCAT = "DIMENSION", DOSCAT might be "LENGTH" or "WIDTH" or "THICKNESS".
Perm
DOORRES
Result or Finding in Original Units
Char
Result Qualifier
Result of the Device Property as originally observed or collected.
DOORRES should contain the result or value of the property defined in DOTEST. For example, if DOTEST is LIFE (shelf life), then DOORRES might be 6 (months).