Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Metadataspec
highlighttrue
keysNotes;Core;
shareqc_sdtmig33sdtm4tig10_ds
ClassFindings
DomainDO
Variable NameVariable LabelTypeControlled Terms, Codelist, or Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharDOIdentifierTwo-character abbreviation for the domain.Req
SPDEVIDSponsor Applicant Device IdentifierChar
Identifier

SponsorApplicant-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
DOSEQSequence NumberNum
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
DOGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a device.Perm
DOREFIDReference IDChar
Identifier

Internal or external identifier.

This could be a scan code or equivalent.

Perm

DOSPID

SponsorApplicant-Defined IdentifierChar
IdentifierSponsorApplicant-defined reference number.Perm
DOTESTCDDevice Property Short NameChar(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
DOTESTDevice Property Test NameChar(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
DOCATCategory for Device In-UseChar*
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
DOSCATSubcategory for Device In-UseChar*
Grouping Qualifier

A further categorization of a measurement or examination.

For example, if DOCAT = "DIMENSION", DOSCAT might be "LENGTH" or "WIDTH" or "THICKNESS".

Perm
DOORRESResult or Finding in Original UnitsChar
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).

Exp
DOORRESUOriginal UnitsChar(UNIT)Variable Qualifier

Original units in which the data were collected.

The unit for DOORRES. Examples: "MONTHS", "cm".

Exp